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The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues. The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.

The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure • Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.

The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

The Arthrex Humeral Plating and Cerclage Button consist of straight humeral plates and a 3.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 90.5 - 309 mm and include suture holes for soft tissue refixation. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294) and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.

Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as bone fixation cerclage the sutures are intended for: - · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty) - · Sternotomy indications including the "rewiring" of osteomized sternums - · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring - · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft) - · Repair of long bone fractures due to trauma or reconstruction - · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament - · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only. The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus. The Arthrex DynaNite Nitinol Staples are indicated for: • Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. • Fixation of proximal tibial metaphysis osteotomy. • Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. • Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum. • When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.

The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.

The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures. The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is 5.0 mm in diameter and 15 mm in length. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is a line extension to the Anti-Rotation Screws cleared within Arthrex Intramedullary Nails (K230257). The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is manufactured from Titanium Alloy conforming to ASTM F136. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is sold sterile and is single-use.

The distal humerus fracture plates and olecranon fracture plates are indicated for adult patients. The distal humerus and olecranon fracture plates are indicated for fixation of fractures of the humerus and ulna.

The Arthrex Elbow Fracture Plating System consists of a series of olecranon and distal humerus plates of varying lengths, thicknesses, and orientations. The proposed plates are contoured and may be available in left and right configurations, ranging from 73 mm to 294.37 mm in length, 1.93 mm to 5.51 mm in thickness, and 10.06 mm to 22 mm in width. Each plate provides locking screw fixation and may include suture holes for soft tissue refixation. The proposed plates are manufactured from stainless steel conforming to ASTM F138 or titanium alloy confirming to ASTM F136 (ISO 5832-3). The plates are sold sterile (Gamma) and non-sterile and are single-use.