OSferion Knochenersatz für Opening Wedge Osteotomie, 12 x 35 mm

Cuña de osteotomía OSferion, 12 mm x 35 mm

Cunha para osteotomia OSferion, 12 mm x 35 mm

Finished Product

AR-13370-3

Human

Knee

Product

OSferion is an osteoconductive bone graft substitute and bone void filler consisting of 100% High Purity Beta-Tricalcium Phosphate (β-TCP). OSferion's micro and macro porous structure allows it to be resorbed and replaced by bone during the healing process when used in conjunction with rigid fixation devices. These revolutionary osteotomy wedges have an unprecedented compressive force of 15-20 MPa (2900 pounds/square inch), comparable to cortical bone, adding improved stability to the correction site. OSferion wedges can be used in conjunction with the Arthrex distal femoral and high tibial opening wedge osteotomy plates and screws. The chamfered wedge design of the implants corresponds to the shape of the open wedge correction performed with the Opening Wedge Osteotomy System. After insertion of the osteotomy plate, the appropriate size OSferion wedges are prepared in a sterile fashion using autogenous blood, or osteotomy site bone marrow and placed within the osteotomy site by hand. The OSferion wedges are placed on either side of the secured osteotomy plate within the osteotomy. They can be trimmed to size using a rongeur.

OSferion Osteotomy Wedge

Child (D)

Orthobiologics

OSferion is an osteoconductive bone graft substitute and bone void filler consisting of 100% High Purity Beta-Tricalcium Phosphate (β-TCP). OSferion's micro and macro porous structure allows it to be resorbed and replaced by bone during the healing process when used in conjunction with rigid fixation devices. These revolutionary osteotomy wedges have an unprecedented compressive force of 15-20 MPa (2900 pounds/square inch), comparable to cortical bone, adding improved stability to the correction site. 
 

OSferion wedges can be used in conjunction with the Arthrex distal femoral and high tibial opening wedge osteotomy plates and screws. The chamfered wedge design of the implants corresponds to the shape of the open wedge correction performed with the Opening Wedge Osteotomy System. After insertion of the osteotomy plate, the appropriate size OSferion wedges are prepared in a sterile fashion using autogenous blood, or osteotomy site bone marrow and placed within the osteotomy site by hand. The OSferion wedges are placed on either side of the secured osteotomy plate within the osteotomy. They can be trimmed to size using a rongeur.

Procedure

Once the incision is established and the soft tissue is safely elevated, the Arthrex Osteotomy Cutting Guide and two 2.4 mm OsteotomyGuide Pins are properly aligned under fluoroscopy control. Specifically design retractors are then used to clear any soft tissue and the osteotomy is precisely performed preserving approximately 1 cm of the medial cortex. The desired amount of angular correction is achieved utilizing the Osteotome Jackor Osteotomy Wedge and the osteotomy site is packed with allograft or autograft bone void filler.

Distal Femoral Osteotomy 

Titanium
Anatomically curved and low profile, ContourLock DFO plates are available in right and left orientations and multiple sizes, depending on the desired amount of correction. The toothless design facilitates greater flexibility through infinite correction potential up to 20 mm without compromising strength.
Titanium Femoral Opening Wedge Osteotomy Plates provide a straight-toothed option to aid in maintaining the osteotomy correction.
These plates are fixated to bone using titanium locking 6.5 mm cancellous and 4.5 mm cortical screws. Each screw can be angled to the proper anatomic orientation within a swiveling bushing before being locked.
Stainless Steel
Low-profile, stainless steel Femoral Opening Wedge Osteotomy Plates are available with a straight tooth to facilitate maintaining the osteotomy. These plates are optimal for unique anatomy that requires a customized fit with multiple bends. The plates are fixated using standard AO stainless steel 6.5 mm cancellous and 4.5 cortical screws.
All of the Femoral Opening Wedge Osteotomy Plates are designed to work in conjunction with the standard <a href="http://www.arthrex.com/knee/opening-wedge-osteotomy-instrument-set">Opening Wedge Osteotomy Instruments Sets.</a>

ContourLock™ Distal Femoral Osteotomy (DFO) Plates and Screws

An alterative to traditional metal plates and screws, the iBalance HTO system consists of nonabsorbable polyetheretherketone (PEEK) implant anchors that are inserted into the proximal tibial opening wedge osteotomy site during HTO procedures to maintain and fixate the osteotomy. The iBalance HTO implants and anchors are intended for permanent implantation and, in some cases, may negate the need for a second surgical procedure to remove hardware due to overlying soft-tissue irritation.
To promote healing and provide additional strength to the repair, biologics such as OSferion osteotomy wedge, Quickset™* cement, AlloSync™ demineralized bone matrix, and autologous conditioned plasma may be used.
*Quickset is a trademark of Graftys, S.A.

iBalance® HTO Implants and Anchors

Using iBalance implants and instrument system to create a safety envelope with locked-in retractors, the iBalance HTO surgical technique builds confidence and familiarity with a step-by-step guide for creating safe, reproducible cuts. The technique significantly reduces the chances of neurovascular injury and lateral hinge fractures,1 and the instruments help align the osteotomy to the sagittal and coronal planes, thus preserving the tibial slope.
Reference
1. Arthrex, GMBH. Data on file (LA2-00030-EN_B). Munich, Germany; 2017.

iBalance® HTO Surgical Technique

Implantat für iBalance HTO System, 12 Grad, Größe S

Implante para HTO, iBalance, 12°, pequeño

iBalance HTO Implant, SM 6˚/MD 5˚

Implantat für iBalance HTO System, 5 Grad, Größe M

Implante para HTO, iBalance, 5°, mediano

iBalance HTO Implant, SM 7˚/MD 6˚

Implantat für iBalance HTO System, 6 Grad, Größe M

Implante para HTO, iBalance, 6°, mediano

iBalance HTO Implant, SM 8˚/MD 7˚

Implantat für iBalance HTO System, 7 Grad, Größe M

Implante para HTO, iBalance, 7°, mediano

iBalance HTO Implant, SM 9˚ / MD 8˚

Implantat für iBalance HTO System, 8 Grad, Größe M

Implante para HTO, iBalance, 8°, mediano

iBalance HTO Implant, SM 10˚/MD 9˚

Implantat für iBalance HTO System, 9 Grad, Größe M

Implante para HTO, iBalance, 9°, mediano

iBalance HTO Implant, SM 11˚/MD 10˚

Implantat für iBalance HTO System, 10 Grad, Größe M

Implante para HTO, iBalance, 10°, mediano

iBalance HTO Implant, SM 13˚/MD 11˚

Implantat für iBalance HTO System, 11 Grad, Größe M

Implante para HTO, iBalance, 11°, mediano

iBalance HTO Implant, SM 14˚/MD 12˚

Implantat für iBalance HTO System, 12 Grad, Größe M

Implante para HTO, iBalance, 12°, mediano

iBalance HTO Implant, SM 15˚/MD 13˚

Implantat für iBalance HTO System, 13 Grad, Größe M

Implante para HTO, iBalance, 13°, mediano

Implantat für iBalance HTO System, 14 Grad, Größe M

Implante para HTO, iBalance, 14°, mediano

Implantat für iBalance HTO System, 15 Grad, Größe M

Implante para HTO, iBalance, 15°, mediano

Implantat für iBalance HTO System, 5 Grad, Größe L

iBalance HTO Implant, LG 6˚/XL 5˚

Implantat für iBalance HTO System, 6 Grad, Größe L

iBalance HTO Implant, LG 7˚/XL 6˚

Implantat für iBalance HTO System, Grad, Größe L

iBalance HTO Implant, LG 8˚/XL 7˚

Implantat für iBalance HTO System, 8 Grad, Größe L

iBalance HTO Implant, LG 9˚/XL 8˚

Implantat für iBalance HTO System, 9 Grad, Größe L

iBalance HTO Implant, LG 10˚/XL 9˚

Implantat für iBalance HTO System, 10 Grad, Größe L

Implante para HTO, iBalance, 10°, grande

iBalance HTO Implant, LG 11˚/XL 10˚

Implantat für iBalance HTO System,11 Grad, Größe L

Implante para HTO, iBalance, 11°, grande

iBalance HTO Implant, LG 12˚/XL 11˚

Implantat für iBalance HTO System, 12 Grad, Größe L

Implante para HTO, iBalance, 12°, grande

iBalance HTO Implant, LG 13˚/XL 12˚

Implantat für iBalance HTO System, 13 Grad, Größe L

Implante para HTO, iBalance, 13°, grande

iBalance HTO Implant, LG 14˚/XL 13˚

Implantat für iBalance HTO System, 14 Grad, Größe L

Implante para HTO, iBalance, 14°, grande

iBalance HTO Implant, LG 15˚/XL 14˚

Implantat für iBalance HTO System, 15 Grad, Größe L

Implante para HTO, iBalance, 15°, grande

Highly specific to iBalance® implants, the iBalance HTO system creates a safety “envelope” with locked-in retractors, allowing the surgeon to create all cuts safely and reproducibly, while significantly reducing chances of neurovascular injury and lateral hinge fractures. The instruments also allow for alignment of the osteotomy to the sagittal and coronal planes to preserve tibial slope. Ideal for mastering high tibial osteotomies, the iBalance HTO system features a step-by-step guided technique to build confidence through safety and reproducibility.

iBalance® HTO System

OSferion is an osteoconductive bone graft substitute and bone void filler consisting of 100% beta-tricalcium phosphate (β-TCP). OSferion’s micro- and macroporous structure allows it to be resorbed and replaced by bone during the healing process. OSferion wedges are intended to be used in conjunction with the distal femoral and high tibial opening wedge osteotomy plates and screws to promote healing and provide added rigidity to the repair. The chamfered wedge design of the OSferion implants corresponds to the shape of the osteotomy and can be easily trimmed to size using a rongeur.

OSferion Osteotomy Wedge, 12 mm

AR-13370-3

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