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BioSync® Reconstruction Wedge Patient Information Leaflet Helping Surgeons Treat Their Patients Better® Since its inception, Arthrex has been committed to one mission: Helping Surgeons Treat Their Patients Better. We are strategically focused on constant product innovation through scientific research, surgeon collaboration, and medical education to make less invasive surgical procedures simpler, safer, and more reproducible. Each year, we develop more than 1000 new innovative products and procedures to advance minimally invasive orthopedics worldwide. Arthrex has always remained a privately held company, which allows for the rapid evaluation of new technologies and ideas. Our economic strength enables us to develop products and techniques that truly make a difference without compromising on quality. Our experienced team of dedicated professionals represents a shared passion and commitment to delivering uncompromising quality to the health care providers who use our products and the millions of patients whose lives we impact. The medical significance of our contributions serves as our primary benchmark of success and will continue into the future as the legacy of Arthrex. Table of Contents 04 Introduction 05 Device Description 06 Material Specifications 07 Indications 08 Contraindications 09 Risks/Adverse Effects 10 Postoperative Care 11 Warnings 12 MRI Safety Information 12 BioSync Reconstruction Wedge 13 Evans Wedge Implant Models 14 Anatomic Cotton Wedge Implant Models 15 Contact Information Introduction The bones of the midfoot and forefoot are intricately structured to support weight, absorb shock, and enable complex movements such as walking, running, and balancing. These bones include the metatarsals, cuneiforms, and the calcaneus, among others. When deformities, injuries, or degenerative conditions affect these bones, surgical correction may be necessary to restore alignment and function. This leaflet contains information about your BioSync reconstruction wedge implant. It may not contain all the information related to your specific procedure and if you have any questions, talk to your healthcare provider. All implants have risks and benefits. Follow your healthcare team's advice even if it differs from what is contained within this leaflet. Please read this leaflet carefully and refer to it in the future if needed. The name and number of your wedge implant can be found on your implant card. If a healthcare professional asks about your implant, please show them your implant card. Introduction | 04 Device Description The BioSync reconstruction wedge is a porous metal wedge used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications. Device Description | 05 Material Specifications The BioSync reconstruction wedge is manufactured from grade 2 chemically pure porous titanium (BioSync-Ti) per ASTM F67 which contains: ❯ Titanium, (balance) ❯ Iron, max (0.30%) ❯ Oxygen, max (0.25%) ❯ Other materials may be present at trace levels. Material Specifications | 06 Indications The BioSync reconstruction wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as: Cotton and Evans Wedges: ❯ Opening wedge osteotomies of the bones of the foot (including osteotomies for hallux valgus, except in Canada) ❯ Opening wedge of medial cuneiform or Cotton osteotomies ❯ Lateral column lengthening (Evans lengthening osteotomy or calcaneal z osteotomy) ❯ Metatarsal/Cuneiform arthrodesis Midfoot Wedges: ❯ Opening wedge osteotomies of the bones of the foot including osteotomies for hallux valgus ❯ Nonunion of arthrodesis of the midfoot including metatarsal/cuneiform arthrodesis (tarsometatarsal (TMT) or lapidus) This device is intended for use with ancillary fixation. The BioSync reconstruction wedge is not intended for use in the spine. Indications | 07 Contraindications 1. Insufficient quantity or quality of bone. 2. Blood supply limitations and previous infections, which may retard healing. 3. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation. 4. Any active infection or blood supply limitations. 5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. 6. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. 7. Do not use for surgeries other than those indicated. Contraindications | 08 Risks/Adverse Effects 1. Infections, both deep and superficial. 2. Foreign body reactions. 3. Unwanted soft tissue damage and / or articular surface damage due to improper wedge placement. Risks/Adverse Effects | 09 Postoperative Care Postoperative management is patient-specific and dependent on your doctor's assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. Please be aware that surgery and recovery protocol may vary for each individual and any questions pertaining to the surgical procedure or postoperative protocol should be discussed with your surgeon. Please call your doctor if: ❯ You experience loss of function/range of motion ❯ You develop a fever greater than 100.4 °F (38 °C) ❯ Drainage continues from the site of your incision ❯ Your surgical site becomes more swollen, tender, and painful, with increased difficulty performing your exercises. If you have difficulty breathing or develop severe pain or chest pain, call your local emergency care or report immediately to your local emergency room. North America emergency services – 911 Postoperative Care | 10 Warnings 1. Caution: Federal law restricts this device to sale by or on the order of a physician. 2. This device is intended to be used by a trained medical professional. 3. An internal fixation device must never be re-used. 4. Procedures carried out using these devices may be used on the general population. 5. The clinical benefits associated with the use of these devices outweigh the known clinical risks. 6. There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices. 7. All metallic implant devices used for this surgical procedure should have the same composition properties. 8. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device. 9. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Device removal should be followed by adequate postoperative management. 10. Detailed instructions and limitations of this device are provided to the surgeon in addition to this patient information leaflet and your patient implant card. 11. These are single-use devices. Reuse of this device could result in the failure of the device to perform as intended and could cause harm to the patient and/or user. 12. Removal of supplemental fixation after healing. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid re-fracture. 13. Serious incidents should be reported to Arthrex, Inc. or an in-country representative, and to the health authority where the incident occurred. Warnings | 11 MR MRI Safety Information MRI, or Magnetic Resonance Imaging, is an imaging technique utilizing a strong magnetic field to produce detailed anatomical images. This section details the information that you should be aware of when receiving an MRI scan. MR Magnetic Resonance (MR) Conditional A patient with this device can be scanned safely in an MR system under the following conditions. Failure to follow these conditions may result in injury. Device Name BioSync Reconstruction Wedge Static Magnetic Field Strength (B0) 1.5-Tesla and 3-Tesla Maximum Spatial Field Gradient 30 T/m or 3000 Gauss/cm RF (Radio Frequency) Excitation Circularly Polarized (CP) RF (Radio Frequency) Transmit Coil Type Volume RF body coil Operating Mode Normal Operating Mode Maximum Whole-Body SAR (Specific Absorption Rate) 1 W/kg Maximum Head SAR 3.2 W/kg Scan Duration Under the scan conditions defined, the BioSync Reconstruction Wedge can be scanned continuously for 10 minutes. With 20 minutes wait time, the sequence can be repeated twice in 60 minutes. MR Image Artifact The presence of this implant may produce an image artifact. Patients who have other MR Conditional devices can be scanned as long as all the MR Conditional scan parameters for each of the devices are met. Do not conduct an MRI scan if any conditions for safe scanning for any device cannot be met. If information about a specific parameter is not included, there are no conditions associated with that parameter. MR The person with a BioSync Reconstruction Wedge implant can safely undergo an MR exam only under very specific conditions. Scanning under different conditions may result in severe injury. Full MRI safety information is available in the MRI Safety Information section of this patient information leaflet or by calling Arthrex customer service at +1 800 934-4404. MRI Safety Information | 12 BioSync Reconstruction Wedge Evans Wedge Implant Models Consult your BioSync Reconstruction Wedge Implant Identification Card for information on the device type/model of the implant used in your procedure. Item Number Product Description AR-8942W-1806 BioSync Evans Wedge, 18 x 18 x 6.5 mm AR-8942W-1808 BioSync Evans Wedge, 18 x 18 x 8 mm AR-8942W-1810 BioSync Evans Wedge, 18 x 18 x 10 mm AR-8942W-1812 BioSync Evans Wedge, 18 x 18 x 12 mm AR-8942W-2006 BioSync Evans Wedge, 20 X 20 X 6.5 mm AR-8942W-2008 BioSync Evans Wedge, 20 X 20 X 8 mm AR-8942W-2010 BioSync Evans Wedge, 20 X 20 X 10 mm AR-8942W-2012 BioSync Evans Wedge, 20 X 20 X 12 mm AR-8942W-2206 BioSync Evans Wedge, 22 X 22 X 6.5 mm AR-8942W-2208 BioSync Evans Wedge, 22 X 22 X 8 mm AR-8942W-2210 BioSync Evans Wedge, 22 X 22 X 10 mm AR-8942W-2212 BioSync Evans Wedge, 22 X 22 X 12 mm BioSync Reconstruction Wedge | 13 BioSync Reconstruction Wedge Anatomic Cotton Wedge Implant Models Consult your BioSync Reconstruction Wedge Implant Identification Card for information on the device type/model of the implant used in your procedure. Item Number Product Description AR-8948W-1645 BioSync Anatomic Cotton Wedge, 16x4.5 mm AR-8948W-1655 BioSync Anatomic Cotton Wedge, 16x5.5 mm AR-8948W-1665 BioSync Anatomic Cotton Wedge, 16x6.5 mm AR-8948W-1675 BioSync Anatomic Cotton Wedge, 16x7.5 mm AR-8948W-2045 BioSync Anatomic Cotton Wedge, 20x4.5 mm AR-8948W-2055 BioSync Anatomic Cotton Wedge, 20x5.5 mm AR-8948W-2065 BioSync Anatomic Cotton Wedge, 20x6.5 mm AR-8948W-2075 BioSync Anatomic Cotton Wedge, 20x7.5 mm BioSync Reconstruction Wedge | 14 Contact Information Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the health authority where the incident occurred. Region Contact 1370 Creekside Blvd. Naples, FL 34108, USA Arthrex, Inc. Arthrex GmbH USA Toll free: +1 800 934-4404 arthrex.com Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 90 90 05-0 arthrex.de USA – U. S. Food & Drug Administration website: https://www.fda.gov/safety/medwatch-fda-safety-information-andadverse-event-reporting-program Contact Information | 15 The information contained in this patient leaflet is not medical advice and is not meant to be a substitute for the advice provided by a surgeon or other qualified medical professional on the use of these products. You should talk with your physician or healthcare provider for more information about your health condition, and whether Arthrex products might be appropriate for you. The surgeon who performs any surgical procedure is responsible for determining and using the appropriate techniques for surgical procedures on each individual patient. Arthrex recommends that surgeons be trained on the use of any particular product before using it in surgery. A surgeon must always rely on their professional medical judgment when deciding whether to use a particular product when treating a particular patient. A surgeon must always refer to the package insert, product label, and/or directions for use before using any Arthrex product. Products may not be available in all markets because product availability is subject to regulatory approvals and medical practices in individual markets. Please contact Arthrex if you have questions about the availability of products in your area. Symbols glossary can be found at www.arthrex.com/symbolsglossary. © 2025-11 Arthrex, Inc. All rights reserved. PIL-0027_US_ENr0 arthrex.com

BioSync® Reconstruction Wedge

Spanish (Español) - es

Sistema de vigas intramedulares Prospecto de información para el paciente

Beaming System Patient Information Leaflet

Arthrex KreuLock™ Screws - Patient Information Leaflet

Arthroplasty Shoulder

Univers Revers™ Shoulder Prosthesis System Patient Information Leaflet Helping Surgeons Treat Their Patients Better™ Since its inception, Arthrex has been committed to one mission: Helping Surgeons Treat Their Patients Better. We are strategically focused on constant product innovation through scientific research, surgeon collaboration, and medical education to make less invasive surgical procedures simple, safer, and more reproducible. Each year, we develop more than 1000 new innovative products and procedures to advance minimally invasive orthopedics worldwide. Arthrex has always remained a privately held company, which allows for the rapid evaluation of new technologies and ideas and the freedom to develop products and techniques that truly make a difference without economic considerations or compromise. Our experienced team of dedicated professionals represents a shared passion and commitment to delivering uncompromising quality to the healthcare providers who use our products and the millions of patients whose lives we impact. The medical significance of our contributions serves as our primary benchmark of success and will continue into the future as the legacy of Arthrex. Table of Contents Device Description ............................................................................................... ...............................................................................................04 04 Material Specifications ........................................................................................ ........................................................................................05 05 Postoperative Care ............................................................................................... ...............................................................................................06 06 MRI Safety Information ........................................................................................ 07 Contact Information .............................................................................................. ..............................................................................................08 08 Device Description The Univers R Revers evers™™ shoulder prosthesis system The Univers Revers shoulder prosthesis system has an articular design that is inverted, compared to traditional total shoulder prosthesis. The system is comprised of two main components: the Arthrex Univers Revers shoulder prosthesis and a glenoid baseplate system. The glenoid baseplate system is comprised of either the Universal Glenoid™ shoulder prosthesis or the Univers Revers™ Modular Glenoid System. The Arthrex Univers Revers shoulder prosthesis is comprised of a humeral stem and epiphysis or humeral cup (i.e., SutureCup), a spacer, and a humeral cup liner. The Universal Glenoid shoulder prosthesis consists of a glenoid baseplate, a glenosphere, and screws. The Univers Revers modular glenoid system consists of a monoblock baseplate or a modular baseplate; both baseplates are available with either a central screw or central post. Modular baseplates are also available with full or half augments that can be obliquely or non-obliquely oriented. The augmented modular baseplates are used with central posts. The baseplates are designed to be used cementless with peripheral screws and a glenosphere. The glenoid system is designed to be used as the glenoid side of the existing Univers Revers shoulder prosthetic system. The Univers Revers cuff arthropathy system (CA humeral head with adapter) is designed to be used with the existing well-fixated Univers Revers stem, or to convert an existing reversed shoulder prosthesis to a hemi anatomic configuration. The Univers Revers cuff arthropathy (CA) humeral head is designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency. Device Description | 4 Material Specifications The Univers R Revers evers™™ shoulder prosthesis system ▪ The humeral device consists of a stem, cup, screw, and spacer manufactured of titanium. The stem body and cup are partly coated with a calcium phosphate (CaP) or hydroxyapatite (HA) coating and the cup is partly coated with a calcium phosphate (CaP) coating. ▪ The humeral inlay component is composed of ultra-high molecular weight polyethylene (UHMWPE). ▪ The Universal Glenoid shoulder prosthesis consists of the baseplate, bushings, a central screw and cancellous screws – all manufactured of titanium. The baseplate is partially coated with calcium phosphate (CaP). The glenosphere is manufactured of cobaltchromium ▪ The Univers Revers modular glenoid system consists of a baseplate, central screw or post and cancellous bone screws - all manufactured of titanium. The baseplates and modular posts are partially coated with CP (commercially pure) titanium. The glenosphere is manufactured of cobalt-chromium. The glenosphere is also manufactured of titanium alloy Ti-6AL-4V ELI. ▪ The Univers Revers CA humeral head is manufactured of cobalt-chromium and the CA head adapter is manufactured of titanium alloy Ti-6Al-4V ELI and UHMWPE. Material Specifications | 5 Postoperative Care Postoperative management is patient-specific and dependent on your doctor's assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. Please be aware that surgery and recovery protocol may vary for each individual and any questions pertaining to the surgical procedure or postoperative protocol should be discussed with your surgeon. Please call your doctor if: ▪ You experience loss of function/range of motion ▪ You develop a fever greater than 38 °Celsius /100.4 °Fahreheit ▪ Drainage continues from the site of your incision ▪ Your surgical site becomes more swollen, tender, and painful, with increased difficulty performing your exercises. If you have difficulty breathing or develop severe pain or chest pain, call 911 or report immediately to your local emergency room. Postoperative Care | 6 MR MRI Safety Information MRI, or Magnetic Resonance Imaging, is an imaging technique utilizing a strong magnetic field to produce detailed anatomical images. This section details the information that you should be aware of when receiving an MRI scan. 1. MR MR Conditional MRI Safety Information A person with the Univers Revers™ shoulder prosthesis system may be safely scanned under the following conditions. Failure to follow these conditions may result in injury. Device Name Univers Revers™ shoulder prosthesis system Static Magnetic Field Strength (B0 - B subscript zero) 1.5-Tesla and 3.0-Tesla Maximum Spatial Field Gradient 30 T/m or 3000 Gauss/cm RF (Radio Frequency) Excitation Circularly Polarized (CP) RF (Radio Frequency) Transmit Coil Type Volume RF body coil Operating Mode Normal Operating Mode Maximum Whole-Body SAR (Specific Absorption Rate) 0.5 W/kg (Normal Operating Mode) Maximum Head SAR N/A Scan Duration Under the scan conditions defined, the Univers Revers™ shoulder prosthesis system can be scanned continuously for 60 minutes. MR Image Artifact The presence of this implant may produce an image artifact of 60 mm. Patients who have other MR Conditional devices can be scanned as long all the MR Conditional scan parameters for each of the devices are met. Do not conduct an MRI scan if any conditions for safe scanning for any device cannot be met. If information about a specific parameter is not included, there are no conditions associated with that parameter. MR A person with an Arthrex Univers Revers shoulder system implant can safely undergo an MR exam only under very specific conditions. Scanning under different conditions may result in severe injury. Full MRI safety information is available in the MRI Safety Information section of this patient information leaflet, Directions for Use (https://edfu.arthrex. https://edfu.arthrex.com com) or by calling Arthrex customer service at +1 800 934-4404. MRI Safety Information | 7 Contact Information Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the health authority where the incident occurred. Region Arthrex, Inc. Arthrex GmbH Arthrex Distribution Hub EMEA B. B.V V. Arthrex LLtd., td., confinis ch-rep ag, Manufacturer' Manufacturer'ss A Australian ustralian Sponsor Arthrex Australia Pty LLtd td Contact 1370 Creekside Blvd. Naples, FL 34108, USA +1 800 934-4404 arthrex. arthrex.com com Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 90 90 05-0 arthrex. arthrex.de de Ampèrestraat 9 5928 PE Venlo, Netherlands +31 88 712 9800 arthrex.nl Unit 1 Bessemer Park Shepcote Lane Sheffield S9 1DZ United Kingdom +44 0 114 232 9180 arthrex. arthrex.co co.uk .uk Hauptstrasse 16 3186 Düdingen, Switzerland +41 26 494 8 494 Suite 501, 20 Rodborough Road Frenchs Forest, NSW, 2086 Australia +1 800 950 637 arthrex. arthrex.com.au com.au USA – U. S. Food & Drug Administration website: https://www https://www..fda. fda.gov/safety/medwatch-fdagov/safety/medwatch-fdasafety-information-and-adverse-event-reporting-program Australia – Therapeutic Goods Administration website: https://www https://www..tga. tga.gov gov.au .au European Union – https://ec. https://ec.europa. europa.eu/growth/sectors/medical-devices/contacts_en eu/growth/sectors/medical-devices/contacts_en Contact Information | 8 Symbols glossary can be found at www www.arthrex. .arthrex.com/symbolsglossary com/symbolsglossary.. The information contained in this patient information leaflet is not medical advice and is not meant to be a substitute for the advice provided by a surgeon or other qualified medical professional on the use of these products. You should talk with your physician or healthcare provider for more information about your health condition, and whether Arthrex products might be appropriate for you. The surgeon who performs any surgical procedure is responsible for determining and using the appropriate techniques for surgical procedures on each individual patient. Arthrex recommends that surgeons be trained on the use of any particular product before using it in surgery. A surgeon must always rely on their professional medical judgment when deciding whether to use a particular product when treating a particular patient. A surgeon must always refer to the package insert, product label, and/or directions for use before using any Arthrex product. Products may not be available in all markets because product availability is subject to regulatory approvals and medical practices in individual markets. Please contact Arthrex if you have questions about the availability of products in your area. arthrex. arthrex.com com © 2024-02 Arthrex, Inc. All rights reserved. PIL-0002-5r0_en-US

Univers Revers™ Shoulder Prosthesis System Patient Information Leaflet

Univers II™, Univers Apex, and Univers Apex OptiFit™ Total Shoulder System Patient Information Leaflet Helping Surgeons Treat Their Patients Better™ Since its inception, Arthrex has been committed to one mission: Helping Surgeons Treat Their Patients Better. We are strategically focused on constant product innovation through scientific research, surgeon collaboration, and medical education to make less invasive surgical procedures simple, safer, and more reproducible. Each year, we develop more than 1000 new innovative products and procedures to advance minimally invasive orthopedics worldwide. Arthrex has always remained a privately held company, which allows for the rapid evaluation of new technologies and ideas and the freedom to develop products and techniques that truly make a difference without economic considerations or compromise. Our experienced team of dedicated professionals represents a shared passion and commitment to delivering uncompromising quality to the healthcare providers who use our products and the millions of patients whose lives we impact. The medical significance of our contributions serves as our primary benchmark of success and will continue into the future as the legacy of Arthrex. Table of Contents Device Description ............................................................................................... ...............................................................................................04 04 Material Specifications ........................................................................................ ........................................................................................05 05 Postoperative Care ............................................................................................... ...............................................................................................06 06 MRI Safety Information ........................................................................................ 07 Contact Information .............................................................................................. ..............................................................................................08 08 Device Description The Univers II™, Univers Apex, and Univers Apex OptiFit™ T Total otal Shoulder S System ystem consists of a stem for fixation within the humerus, a spherical head for replacing the humeral head, and a trunion to connect the head to the stem. The stems and heads are available in a variety of sizes. The Univers™ Apex total shoulder system consists of a stem for fixation within the humerus, a spherical head for replacing the humeral head, and a trunion to connect the head to the stem. The Univers Apex OptiFit Humeral Stem is a component of Univers II total shoulder system. The stems and heads are available in a variety of sizes. The Univers Apex stem and Univers Apex OptiFit humeral stem are identical to the existing Univers II stem, except for the overall length. The Univers Apex and Univers Apex OptiFit stems length has been shortened to optimize bone conservation. The stem and trunions in the Univers II, Univers Apex and Univers Apex OptiFit systems are comprised of titanium. The heads are available in cobalt alloy or titanium alloy. The Univers VaultLock® keeled and pegged glenoids are comprised of ultra-high molecular weight polyethylene (UHMWPE) and available in a variety of sizes. The Univers VaultLock may include a half wedge augment. Device Description | 4 Material Specifications Univers II, Univers Apex and Univers Apex OptiFit T Total otal Shoulder S System ystem ▪ The device consists of a stem body manufactured of titanium and may be partly coated with titanium plasma spray coating (TPS), a metal head support of titanium alloy, and a head manufactured of cobalt-chromium (Co-Cr) alloy. Humeral heads are also offered in titanium alloy 6L-4V Eli. The glenoid component is composed of ultra-high molecular weight polyethylene (UHMWPE). Material Specifications | 5 Postoperative Care Postoperative management is patient-specific and dependent on your doctor's assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. Please be aware that surgery and recovery protocol may vary for each individual and any questions pertaining to the surgical procedure or postoperative protocol should be discussed with your surgeon. Please call your doctor if: ▪ You experience loss of function/range of motion ▪ You develop a fever greater than 38° Celsius / 100.4° Fahrenheit ▪ Drainage continues from the site of your incision ▪ Your surgical site becomes more swollen, tender, and painful, with increased difficulty performing your exercises. If you have difficulty breathing or develop severe pain or chest pain, call 911 or report immediately to your local emergency room Postoperative Care | 6 MR MRI Safety Information MRI, or Magnetic Resonance Imaging, is an imaging technique utilizing a strong magnetic field to produce detailed anatomical images. This section details the information that you should be aware of when receiving an MRI scan: 1. MR MR Conditional MRI Safety Information A person with the Arthrex Univers II, Univers Apex, and Univers Apex OptiFit Total Shoulder System may be safely scanned under the following conditions. Failure to follow these conditions may result in injury. Device Name Univers II, Univers Apex, and Univers Apex OptiFit Total Shoulder System Static Magnetic Field Strength (B0 - B subscript zero) 1.5-Tesla and 3.0-Tesla Maximum Spatial Field Gradient 30 T/m or 3000 Gauss/cm RF (Radio Frequency) Excitation Circularly Polarized (CP) RF (Radio Frequency) Transmit Coil Type Volume RF body coil Operating Mode Normal Operating Mode Maximum Whole-Body SAR (Specific Absorption Rate) 0.5 W/kg (Normal Operating Mode) Maximum Head SAR N/A Scan Duration Under the scan conditions defined, the Arthrex Shoulder System can be scanned continuously for 60 minutes. MR Image Artifact The presence of this implant may produce an image artifact of 60 mm. Patients who have other MR Conditional devices can be scanned as long all the MR Conditional scan parameters for each of the devices are met. Do not conduct an MRI scan if any conditions for safe scanning for any device cannot be met. If information about a specific parameter is not included, there are no conditions associated with that parameter. MR A person with an Arthrex Univers II, Univers Apex, and Univers Apex OptiFit Total Shoulder System implant can safely undergo an MR exam only under very specific conditions. Scanning under different conditions may result in severe injury. Full MRI safety information is available in the MRI Safety Information section of this patient information leaflet, Directions for Use (https://edfu.arthrex. https://edfu.arthrex.com com) or by calling Arthrex customer service at +1 (800) 934-4404. MRI Safety Information | 7 Contact Information Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the health authority where the incident occurred. Region Arthrex, Inc. Arthrex GmbH Arthrex Distribution Hub EMEA B. B.V V. Arthrex LLtd., td., confinis ch-rep ag, Manufacturer' Manufacturer'ss A Australian ustralian Sponsor Arthrex Australia Pty LLtd td Contact 1370 Creekside Blvd. Naples, FL 34108, USA +1 800 934-4404 arthrex. arthrex.com com Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 90 90 05-0 arthrex. arthrex.de de Ampèrestraat 9 5928 PE Venlo, Netherlands +31 88 712 9800 arthrex.nl Unit 1 Bessemer Park Shepcote Lane Sheffield S9 1DZ United Kingdom +44 0 114 232 9180 arthrex. arthrex.co co.uk .uk Hauptstrasse 16 3186 Düdingen, Switzerland +41 26 494 8 494 Suite 501, 20 Rodborough Road Frenchs Forest, NSW, 2086 Australia +1 800 950 637 arthrex. arthrex.com.au com.au USA – U. S. Food & Drug Administration website: https://www https://www..fda. fda.gov/safety/medwatch-fdagov/safety/medwatch-fdasafety-information-and-adverse-event-reporting-program Australia – Therapeutic Goods Administration website: https://www https://www..tga. tga.gov gov.au .au European Union – https://ec. https://ec.europa. europa.eu/growth/sectors/medical-devices/contacts_en eu/growth/sectors/medical-devices/contacts_en Contact Information | 8 Symbols glossary can be found at www www.arthrex. .arthrex.com/symbolsglossary com/symbolsglossary.. The information contained in this patient information leaflet is not medical advice and is not meant to be a substitute for the advice provided by a surgeon or other qualified medical professional on the use of these products. You should talk with your physician or healthcare provider for more information about your health condition, and whether Arthrex products might be appropriate for you. The surgeon who performs any surgical procedure is responsible for determining and using the appropriate techniques for surgical procedures on each individual patient. Arthrex recommends that surgeons be trained on the use of any particular product before using it in surgery. A surgeon must always rely on their professional medical judgment when deciding whether to use a particular product when treating a particular patient. A surgeon must always refer to the package insert, product label, and/or directions for use before using any Arthrex product. Products may not be available in all markets because product availability is subject to regulatory approvals and medical practices in individual markets. Please contact Arthrex if you have questions about the availability of products in your area. arthrex. arthrex.com com © 2024-02 Arthrex, Inc. All rights reserved. PIL-0002-4r0_en-US

Univers II™, Univers Apex, and Univers Apex OptiFit™ Total Shoulder System - Patient Information Leaflet

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A Patient Leaflet is a guide created specifically for patients to use as reference for information about their implant.

Patient Leaflets

Patient