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The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot. Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.

The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.

The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).

The CoLink® PCR Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle.

The In2Bones CoLink® PCR Plating System includes plates and screws and surgical instruments intended for treating fusions and fractures of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® PCR Plating System. The CoLink® PCR Plating System consists of the MTP Narrow NX and Universal style plates available in Carbon Fiber Reinforced PEEK-OPTIMA™ with Barium Sulfate. The plates are used with previously cleared 3.0mm and 3.5mm titanium alloy locking and non-locking screws.

The Hercules® Syndesmosis Implant System is intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures and as an adjunct in external and intramedullary fixation systems. The Hercules® Syndesmosis Implant System is also intended to provide fixation during healing process after joint reconstruction in the midfoot and forefoot including correction of hallux valgus deformity.

The In2Bones Hercules® Syndesmosis Implant System is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two low profile titanium alloy buttons, designed to complement plate fixation or to allow use as a stand-alone device. This device is also packaged with various ancillary instruments to aid in insertion.

The Avenger Radial Head System is intended for replacement of the proximal end of the radius: • Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with: - a. Joint destruction and/or subluxation visible on x-ray; and/or - b. Resistance to conservative treatment. - · Primary replacement after fracture of the radial head. - · Symptomatic sequelae after radial head resection. - Revision following failed radial head arthroplasty. The components are intended for uncemented use.

The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The subject of this 510(k) is to clear a new range of stem implants (+4mm offset stems) that can be used to extend the current range of the Avenger Radial Headle modular system. The implant allows for replacement of the radial head.

The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.

The In2Bones CoLink® NeoFuse Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System.

The In2Bones USA, CoLink Vallux Plating System is indicated for fixational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The In2Bones CoLink Vallux Plating System includes a plate and screws and surgical instruments used to treat Hallux Valgus and reconstruction of bone for bunion corrections. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink Vallux Plating System.

The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.

The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.

The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).

The In2Bones Hercules™ Suture Anchors are intended for use in the following applications: 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. 2. Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction. 3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair. 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction. 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.