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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, 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 and Reconstruction, Gluteal Tendon Repair

The 1.8 Knotless FiberTak® Soft Anchor with #2 Suture is also intended to be used for osteochondral fixation and fractures, including surgeries with autograft and allograft tissues, in the Knee and Hip.

The Arthrex FiberTak Suture Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The anchor (sheath) and connected sutures are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and/or Polyester. The subject anchors are impacted into a pilot hole via their inserter. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sheath within the pilot hole. The subject devices are provided sterile (Ethylene Oxide), are single-use, and are packaged in a dual-barrier configuration.

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The FiberTape Button is intended to be used for fixation of bone to bone or soft tissue to bone and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering the FiberTape Button for primary or secondary fixation for ACL, PCL, MCL, POL, LCL, MPFL, ALL, PLC, Quadriceps Tendon, and Patellar Tendon repair and reconstruction and Iliotibial Band tenodesis.

The FiberTape Button is a suture-button construct comprised of a titanium button and nonabsorbable suture. The device is provided sterile and is single-use.

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The Arthrex FibuLock Nail System is intended for use in the fixation of fibula fractures and osteotomies.

The Buttress Plate is intended for use with the FibuLock PRO Nail and Arthrex TightRope Syndesmosis Devices to support additional stabilization for fibula fractures. The Buttress Plate is designed for use with the FibuLock PRO Nail and TightRope Syndesmosis devices and may not be used as a stand-alone device.

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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 (Anatomic Humeral Plate) and Cerclage Button consist of contoured humeral plates and a 4.5 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 92 - 265 mm and include suture holes for soft tissue repair. 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), Arthrex 4.0 mm screws (K150456, K143614, and K103705), and Arthrex 4.5 mm screws (K141735).

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The Nano FiberTak Suture Anchor is intended to be used for soft tissue to bone fixation with indications for use in:

Hand and Wrist
Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor, and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.

The Arthrex Nano FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with a push-in design preloaded on an inserter with needles. The anchor (sheath) and connected sutures are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyester. The device is provided sterile (Ethylene Oxide) and is packaged in a dual-barrier configuration for single-use.

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The Arthrex Lateral Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.

The Arthrex Medial Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.

The Arthrex Posteromedial Proximal Tibia Plates are intended to be used for internal bone fixation for bone fractures in the tibia.

The Arthrex Variable Angle (VA) Proximal Tibia Plating System is designed for repairing fractures of the tibia. The Arthrex Variable Angle (VA) Proximal Tibia Plating System consists of two Lateral Proximal Tibia Plate types (Standard and High), Posteromedial Proximal Tibia Plates, and Medial Proximal Tibia Plates. The Lateral Proximal Tibia Plates are anatomically contoured, available in left and right configurations, varying plate lengths of 78 mm to 239 mm. The primary difference between the Standard and High Lateral Proximal Tibia Plates is that the High Lateral Proximal Tibia Plate includes four additional 2.7 mm screw holes proximally. The Medial Proximal Tibia Plates are anatomically contoured, available in left and right configuration, and varying plate lengths of 94 mm to 202 mm. The Posteromedial Proximal Tibia Plates are anatomically contoured straight plates offered in varying plate lengths of 87 mm to 137 mm. The Lateral, Posteromedial, and Medial Proximal Tibia Plates within the Arthrex Variable Angle (VA) Proximal Tibia Plating System accept variable angle (VA) and nominal angle locking screws, KreuLock™ screws, cortical screws, as well as cancellous screws. Additionally, the Variable Angle (VA) Proximal Tibia Plates includes K-wire holes for temporary fixation and suture holes to assist in soft tissue management. The proposed plates are manufactured from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136 (ISO 5832-3). The Variable Angle (VA) Proximal Tibia Plates are single use and sold either sterile (Gamma) or non-sterile.

The Arthrex Variable Angle (VA) Proximal Tibia Plating System are compatible with the following Arthrex Screws:

• 2.7 mm Cortical Screw and 2.7 mm VAL Screw (K220937)
• 2.7 mm VAL KreuLock Screws (K242554)
• 3.0 mm Low Profile VA Locking Screw (K213837)
• 3.0 mm KreuLock™ Compression Screw, 3.0 Low Profile VA Locking Screw, Hybrid, 3.0 mm Hybrid KreuLock™ Compression Screw (K242554)
• 3.5 mm Low Profile Screw (K203294, K150456, K143614, K123241, K111253, K103705)
• 3.5 mm Low Profile Locking Screws (K150456, K143614, K111253, K103705)
• 3.5 mm Variable Angle Locking (VAL) Screw, Reinforced, 3.5 mm Variable Angle Locking (VAL) KreuLock™ Screw, Reinforced, 3.5 VAL Screw, 3.5 mm VAL KreuLock Screws (K241592)
• 4.0 mm Low Profile Screw, Cancellous (K150456, K143614, K111253, K103705)

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The Anatomic Lapidus Plates and I-Beam Lapidus Plates are intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the foot.

The Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates consists of a series of plates of varying sizes, orientations, and lengths. The proposed plates are available in small, medium, and long, and left and right configurations. The proposed plates (I-Beam Lapidus Plates only) include an internal beam. Each plate provides locking screw fixation. The proposed plates are manufactured from titanium alloy conforming to ASTM F136. The proposed plates are sold sterile (gamma) and are single-use. The proposed Anatomic Lapidus Plates are sold as standalone, whereas the I-Beam Lapidus Plates are packaged as a kit with instrumentation.

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The Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is intended to be used for suture or tissue fixation in the foot/ankle and hand/wrist. Specific indications for use are listed below:

• Hand/Wrist: Repair of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus Reconstruction

The proposed Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is a knotless, two-component suture anchor consisting of a fully threaded and vented anchor body and a closed eyelet. The anchor and eyelet are manufactured from polyetheretherketone (PEEK Optima per ASTM F2026). The anchor and eyelet are preassembled on a disposable inserter with a suture threader. Arthrex recommends the use of the Arthrex 1.3 mm SutureTape (sold separately) previously cleared within Arthrex SutureTape (K193575). The proposed device is offered sterile, single-use, and is packaged in a single-pack (one per box).

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The Syndesmosis TightRope PRO is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Syndesmosis TightRope PRO is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The Syndesmosis TightRope PRO devices are comprised of various configurations of two metal buttons (round and oblong) preloaded onto an inserter with #5 suture (implanted) and #2-0 FiberWire suture (passing suture), a one-hole washer or two-hole buttress plate. The proposed Syndesmosis TightRope PRO devices will utilize the existing #5 suture (implanted) and two-hole buttress plate previously cleared within K201522 – Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. The proposed Syndesmosis TightRope PRO devices may be packaged as standalone devices or together with ancillary instruments to aid in insertion.

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