Implant System, Secondary Fixation with BioComposite SwiveLock Anchor 4.75 x 19.1 mm

Finished Product

AR-1593-BC

Human

Knee

Product

The ACL Backup Fixation System includes the implants and instruments needed to back up the fixation sutures of an ACL graft or the InternalBrace™ ligament augmentation of an ACL reconstruction or primary repair. The kit contains a 4.75 mm SwiveLock® implant, as well as a spade-tipped drill and disposable tap. Strong tibial fixation, an important factor in successful ACL reconstructions, is reliable and reproducible with the ACL Backup Fixation System.&nbsp;
The InternalBrace surgical technique is intended only to augment the primary repair/reconstruction by expanding the area of tissue approximation during the healing period and is not intended as a replacement for the native ligament. The InternalBrace technique is for use during soft tissue-to-bone fixation procedures and is not cleared for bone-to-bone fixation.&nbsp;

ACL Backup Fixation System

Child (D)

Procedure

Arthrex offers a comprehensive selection of fixation devices for a variety of bone-patellar tendon-bone (BTB) graft techniques. These options include adjustable, continuous-loop suspensory fixation, and interference screws in a variety of materials. The TightRope® implant, which has been used in 2 million procedures globally,1 was designed to simplify ACL reconstruction and facilitate advanced techniques, such as the GraftLink® technique. BioComposite FastThread™ interference screws, which are composed of time-tested material with more than a decade of clinical success and implantation, allow for faster screw insertion and better graft protection.2
References
1. Arthrex, Inc. Data on file (sales data as of September 18, 2018). Naples, FL; 2018.
2. Arthrex, Inc. LA1-0199-EN_E. Naples, FL; 2018.
Please note that certain bio (PLLA) anchors and screws are not available for sale in EMEA.

BTB Autograft ACL Reconstruction 

There has been a renewed interest in ACL primary repairs as the treatment for Sherman type I and type II ACL ruptures. Careful analysis of historical data has revealed that certain ACL tear subgroups, especially proximal tears with good tissue quality, have positive clinical outcomes with primary ACL repair.1
Studies reporting outcomes of remnant-preserving ACL surgeries have shown encouraging results and a greater potential for early healing and better functional outcomes compared with remnant-resecting surgeries.2 Preservation of the native ACL using the primary repair technique can achieve short-term clinical success and result in good clinical outcomes at 3-year follow-up in this carefully selected patient population.3
Arthroscopic primary repair is minimally invasive because no grafts need to be harvested, no graft tunnels or sockets need to be drilled, and revision surgery, if necessary, is more analogous to primary reconstructions.4 The goal of the procedure is to preserve the remnant native ligament. By doing this, the native nerve endings and blood supply are preserved.5
References
1. van der List JP, DiFelice GS. Role of tear location on outcomes of open primary repair of the anterior cruciate ligament: a systematic review of historical studies. Knee. 2017;24(5):898-908. doi:10.1016/j.knee.2017.05.009
2. van der List JP, DiFelice GS. Successful arthroscopic primary repair of a chronic anterior cruciate ligament tear 11 years following injury. HSS J. 2017;13(1):90-95. doi:10.1007/s11420-016-9530-8
3. Jonkergouw A, van der List JP, DiFelice GS. Arthroscopic primary repair of proximal anterior cruciate ligament tears: outcomes of the first 56 consecutive patients and the role of additional internal bracing. Knee Surg Sports Traumatol Arthrosc. 2019;27(1):21-28. doi:10.1007/s00167-018-5338-z
4. DiFelice GS, Villegas C, Taylor S. Anterior cruciate ligament preservation: early results of a novel arthroscopic technique for suture anchor primary anterior cruciate ligament repair. Arthroscopy. 2015;31(11):2162-2171. doi:10.1016/j.arthro.2015.08.010
5. DiFelice GS, van der List JP. Arthroscopic primary repair of proximal anterior cruciate ligament tears. Arthrosc Tech. 2016;5(5):e1057-e1061. doi:10.1016/j.eats.2016.05.009

ACL Repair

An innovative approach to ACL preservation, the ACL Repair TightRope implant enables precise, incremental repair tensioning and retensioning. Additionally, the FiberRing suture allows for simplified and reproducible suture passing and implant loading. Careful analysis of historical data has revealed that certain ACL tear subgroups, especially proximal tears with good tissue quality, have positive clinical outcomes with primary ACL repair.1
Reference
1. Arthrex, Inc. Data on file (DOC1-000178-en-US_B). &nbsp;Naples, FL; 2020.

ACL Repair TightRope® Implant With FiberRing™ Sutures

Orthobiologics

The BioACL technique harnesses the power of next-generation biologics to provide the ultimate anatomic, minimally invasive, reproducible approach for taking patient outcomes to the next level.
By prefilling ACL bone tunnels with a powerful composite of concentrated platelet-rich plasma (cPRP) from bone marrow aspirate (BMA) or whole blood processed with the Angel® system, the patient’s own bone collected with the GraftNet™ device, and AlloSync® Pure demineralized bone matrix, the BioACL technique provides all the necessary healing components for an ACL reconstruction procedure.
In conjunction with the QuadLink™ with InternalBrace™ technique, the BioACL technique has been shown to result in earlier range of motion, improved limb symmetry, less bone-tunnel widening, and improved patient-reported outcomes as compared to nonaugmented ACL procedures.1&nbsp;
 
 
Reference
1. Lavender CD, Schaver AL, Taylor S, et al. Anterior cruciate ligament reconstruction augmentation with bone marrow aspirate concentrate, demineralized bone matrix, and suture tape shows no difference in outcomes—but faster functional recovery—versus non-augmented anterior cruciate ligament reconstruction. Arthroscopy. Published online July 22, 2024.&nbsp;<a href="https://doi.org/10.1016/j.arthro.2024.06.042">https://doi.org/10.1016/j.arthro.2024.06.042</a>
 
The&nbsp;InternalBrace surgical technique is intended only to augment the primary repair/reconstruction by expanding the area of tissue approximation during the healing period and is not intended as a replacement for the native ligament. The&nbsp;InternalBrace technique is for use during soft tissue-to-bone fixation procedures and is not cleared for bone-to-bone fixation.

BioACL™ Technique

Arthrex offers the most advanced techniques and instruments for hamstring harvesting and preparation for ACL reconstruction. A reproducible harvest can be performed through a traditional anterior or posterior approach using the minimally invasive hamstring harvest technique and specialized tendon strippers.
The GraftLink®&nbsp;technique provides an anatomic, minimally invasive, and reproducible ACL reconstruction procedure. When used in combination with anatomic guides, the FlipCutter® III drill allows independent femoral and tibial "retrodrilling" to create sockets while maintaining the cortices to maximize fixation. Femoral and tibial TightRope® II implants, with a proprietary 5-point locking system, make the GraftLink technique the most reproducible ACL reconstruction available.
Anatomic: Independent tibial and femoral socket preparation with FlipCutter III reamer and/or low-profile reamers facilitate unconstrained placement of the ACL graft.
Minimally Invasive: Socket preparation with the FlipCutter III reamer limits soft-tissue dissection and helps preserve bone and periosteum.
Reproducible: The GraftPro® graft prep system simplifies graft preparation; the tapered graft and adjustable ACL TightRope II buttons facilitate graft passing, fine tuning of graft depth, and graft tensioning from the femoral and tibial sides.

Hamstring Autograft ACL Reconstruction

For over a decade, Arthrex has offered multiple collateral ligament reconstruction techniques, ranging from socket and tunnel based aperture fixation with FastThread™ interference screws to suspensory fixation using TightRope® technology.
In cases of avulsion type injuries, a primary LCL/PLC repair may be performed to restore stability while preserving native anatomy. The versatile line of Knee FiberTak® anchors offers various onlay fixation options, utilizing both knotted and knotless SutureTape technology in addition to the InternalBrace™ technique.
The InternalBrace surgical technique is intended only to augment the primary repair/reconstruction by expanding the area of tissue approximation during the healing period and is not intended as a replacement for the native ligament. The InternalBrace technique is for use during soft tissue-to-bone fixation procedures and is not cleared for bone-to-bone fixation.&nbsp;

Lateral Collateral Ligament (LCL) and Posterolateral Corner (PLC) Repair

MCL reconstruction is typically performed when the MCL is severely injured or in cases of chronic MCL laxity. During an MCL reconstruction, autograft or allograft tissue is used to reconstruct the injured ligament. Graft-fixation technology for MCL reconstruction has evolved from staples, posts and washers, and interference screws to less invasive and easier-to-use suspensory fixation, including the TightRope® implant, and 
all-suture anchor technology, such as the Knee FiberTak® anchor.&nbsp;
Adding the InternalBrace™ technique to an MCL repair may result in lower failure rates and less residual laxity post-op as well as shorter immobilization times and faster return to play.1 Additionally, FiberTape® suture has been used for more than 15 years in more than 4 million cases, including tendon and ligament-bridging repairs.
The InternalBrace surgical technique is intended only to support the primary repair and is not intended as a replacement for the standard of care using biologic augmentation in a primary repair.&nbsp;The InternalBrace surgical technique is intended only for soft-tissue-to-bone fixation and is not cleared for bone-to-bone fixation.
Reference
 
1. van Eck CF, Nakamura T, Price T, Linde M, Smolinski P. Suture tape augmentation improves laxity of MCL repair in the ACL reconstructed knee.&nbsp;Knee Surg Sports Traumatol Arthrosc. 2021;29(8):2545-2552. doi:10.1007/s00167-020-06386-7

Medial Collateral Ligament (MCL) Reconstruction

Certain MCL injuries, including femoral and tibial avulsion injuries, such as Stener lesions, are more amenable to repair than others.1&nbsp;
Using FiberTape® suture for the InternalBrace™ technique for MCL repair has been shown to provide additional stabilization compared to an MCL repair using only suture.2 Adding the InternalBrace technique to an MCL repair may result in lower failure rates and less residual laxity post-op as well as shorter immobilization times and faster return to play.2 FiberTape sutures have been used for more than 15 years in more than 4 million cases, including tendon and ligament-bridging repairs.
The InternalBrace surgical technique is intended only to support the primary repair and is not intended as a replacement for the standard of care using biologic augmentation in a primary repair.&nbsp;The InternalBrace surgical technique is intended only for soft-tissue-to-bone fixation and is not cleared for bone-to-bone fixation.
References
 
1. Shultz CL, Poehlein E, Morriss NJ, et al. Nonoperative management, repair, or reconstruction of the medial collateral ligament in combined anterior cruciate and medial collateral ligament injuries-which is best? a systematic review and meta-analysis.&nbsp;Am J Sports Med. 2024;52(2):522-534. doi:10.1177/03635465231153157 

2. van Eck CF, Nakamura T, Price T, Linde M, Smolinski P. Suture tape augmentation improves laxity of MCL repair in the ACL reconstructed knee.&nbsp;Knee Surg Sports Traumatol Arthrosc. 2021;29(8):2545-2552. doi:10.1007/s00167-020-06386-7&nbsp;

Medial Collateral Ligament (MCL) Repair 

Ruptures of the quadriceps and patellar tendons are common in elite and recreational athletes. Most surgeons treat these injuries surgically to lessen the risk of long-term disability and morbidity.&nbsp;
Historically, open techniques have been used for rupture repairs, but these techniques may be complicated by wound-healing issues and infection. The minimally invasive Percutaneous Achilles Repair System (PARS) technique can be used to treat quadriceps, patellar, and Achilles tendon ruptures.

Patellar Tendon Repair

PCL injuries occur during sports-related activities or high-velocity, traumatic accidents. Indications for operative treatment of PCL tears include acute injuries, active young patients, and either isolated grade 3 tears or combined injuries, such as a grade 2 injury with posterolateral corner instability. 

Arthrex developed several techniques for isolated PCL injuries—including PCL inlay reconstruction, double-bundle PCL reconstruction, and the transtibial PCL RetroConstruction™ procedure—that can be combined with multiligament or posterolateral corner reconstruction.
Additionally, a comprehensive line of PCL reconstruction instrumentation is available for a variety of PCL reconstruction techniques, as well as autografts and allografts and single- or double-bundle options.

Posterior Cruciate Ligament (PCL) Reconstruction

A technique gaining popularity, PCL repair is generally indicated for bony avulsions that can occur on either the femur or tibia.&nbsp;
PCL injuries can happen during sports-related activities or high-velocity, traumatic accidents. Applications for operative treatment of PCL tears include acute injuries, tears in active young patients, and either isolated grade 3 tears or a combined injury, such as grade 2 tears with posterolateral corner instability.
PCL tears can be treated with innovative, minimally invasive procedures using the PCL Repair TightRope® implant and FiberRing™ sutures.

Posterior Cruciate Ligament (PCL) Repair 

Quadriceps tendon grafts offer unique benefits for cruciate ligament reconstruction, such as a predictably large diameter, low morbidity,1 and a preferable stiffness profile for knee ligament reconstruction.
The QuadPro™ tendon harvester is designed to harvest a quadriceps or patellar tendon graft using a minimally invasive technique.2-4 The sharp tip cores out an approximate cylindrical graft. The harvester's ergonomically designed handle features graduations on the clear shaft to allow visualization of approximate graft length during harvesting. Available in four sizes (8 mm to 11 mm), the QuadPro tendon harvester can accommodate each patient’s unique needs as well as the surgeon’s preference for graft diameter.
The FiberTag® TightRope® implant facilitates attachment of single-ended grafts, such as quadriceps tendon grafts, to the ACL TightRope RT and ABS implants. FiberTag suture is integrated into the TightRope implant for a strong, consistent connection between the suture and TightRope loop. A simplified suturing technique, along with innovative packaging and the GraftClamp graft preparation instrument, make preparing quadriceps tendon grafts faster and more reproducible than ever.
References
1. Arthrex, Inc. LA1-00100-EN_K. Naples, FL; 2021.
2. Xerogeanes JW, Mitchell PM, Karasev PA, Kolesov IA, Romine SE. Anatomic and morphological evaluation of the quadriceps tendon using 3-dimensional magnetic resonance imaging reconstruction: applications for anterior cruciate ligament autograft choice and procurement. Am J Sports Med. 2013;41(10):2392-2399. doi:10.1177/0363546513496626
3. Hadjicostas PT, Soucacos PN, Berger I, Koleganova N, Paessler HH. Comparative analysis of the morphologic structure of quadriceps and patellar tendon: a descriptive laboratory study. Arthroscopy. 2007;23(7):744-750. doi:10.1016/j.arthro.2007.01.032
4. Krebs N, Yaish A, O’Neill N. Anatomic evaluation of the quadriceps tendon in cadaveric specimens: application for anterior cruciate ligament reconstruction graft choice. SMRJ. 2019;4(1):7961. doi:10.51894/001c.7961

Quad Tendon Autograft ACL Reconstruction

Ruptures of the quadriceps and patellar tendons are common in elite and recreational athletes. Most surgeons treat these injuries surgically to lessen the risk of long-term disability and morbidity. Historically, open techniques have been used for rupture repairs but may be complicated by wound-healing issues and infection. The minimally invasive Percutaneous Achilles Repair System (PARS) technique can be used to treat quadriceps, patellar, and Achilles tendon ruptures.
The PARS technique helps facilitate consistent capture of the distal aspect of the quadriceps tendon and includes color-coded FiberWire® and FiberTape® sutures. The anatomically contoured guide is reusable, while the suture and passing needles come packaged in a convenient kit. Choose transverse suture, locking suture, or both. The colored FiberWire sutures offer a more organized approach to identifying and securing matched pairs.

Quadriceps Tendon Repair 

Relatively uncommon knee injuries, tibial spine avulsion fractures typically occur in children and adolescents.1 Despite the low incidence of tibial spine avulsion fractures, they deserve ample attention to ensure knee function and stability are correctly restored.
Innovative FiberRing™ sutures provide a simple and reproducible technique for securing the distal remnant to achieve anatomic reduction. The ACL Repair TightRope® implant offers titratable knotless fixation to ensure ACL length is appropriately restored and maintained.
Finally, the ACL InternalBrace™ ligament augmentation button accommodates the InternalBrace technique to help prevent excess range of motion during the healing phase and potentially reduce the chances of secondary injury.2,3
References
1. Williams NR, Yin S, Guzman AJ, et al. Tibial spine avulsion repair with FiberRing suture and anterior cruciate ligament repair TightRope.&nbsp;Arthrosc Tech. 2023;12(12):e2381-e2385. doi:10.1016/j.eats.2023.08.008
2. Mackay GM, Blyth MJ, Anthony I, Hopper GP, Ribbans WJ. A review of ligament augmentation with the InternalBrace™ the surgical principle is described for the lateral ankle ligament and ACL repair in particular, and a comprehensive review of other surgical applications and techniques is presented. Surg Technol Int. 2015;26:239-255.
3. Smith PA, Bley JA. Allograft anterior cruciate ligament reconstruction utilizing internal Brace augmentation. Arthrosc Tech. 2016;5(5):e1143-e1147. doi:10.1016/j.eats.2016.06.007

Implant System, Secondary Fixation with BioComposite SwiveLock Anchor 4.75 x 19.1 mm

AR-1593-BC

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