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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-FiTM, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use.

The Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.

Acumed Wrist Plating System is a set of plates, screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Congruent Bone Plate Systems, per K012655, K120903 and K102998. Acumed Wrist Plating System plates and screws are designed to provide fixation for fractures of the distal radius and ulna. The system provides plates and screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the plates and screws are manufactured from titanium alloy per ASTM F136 and pure titanium per ASTM F67, are single use and are provided both sterile and non-sterile. The Acumed Wrist Plating System plates and screws are an extension of the Congruent Bone Plate family with new lengths and the addition of new size plates and screws. Plates and screws are intended for single patient use only. Instruments supplied with the Acumed Wrist Plating System are intended to aid removal. Instruments are supplied sterile and non-sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.

Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.

Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333. Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile. The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used. Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.

Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation. Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous. The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile. Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.

The Acumed Ankle Syndesmosis Repair System 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 Acumed Ankle Syndesmosis Repair 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.

The Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma. The Acumed Ankle Syndesmosis Repair System contains a fibula button, a tibia button and a high strength fiber suture assembled onto a driver, and is provided in a sterile kit as two options, one with and one without a drill. The system also offers optional washers in a separate sterile kit. The driver and drill are part of the sterile kits and are not available individually. The metal implants including the buttons and washers are manufactured from Titanium Alloy (Ti 6AL-4V ELI per ASTM F136) and the suture is manufactured from ultra-high-molecular-weight polyethylene (UHMWPE).

The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions and dislocations of the acromioclavicular joint.

The Acumed Clavicle Hook Plating System contains pre-contoured hook plates, 3.5mm locking screws and other typical instrumentation for AC joint reduction or distal clavice fragments cases. All implants are manufactured from Titanium Alloy (Ti 6AL-4V) per ASTM F136 and are provided both sterile and non-sterile.

The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula, Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

The Acumed Small Fragment Base Set contains orthopedic plates and screws indicated for general fragment fixation as described below. Plates and screws are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136, or from commercially pure titanium per ASTM F67. All implants are provided both sterile and non-sterile. The set also contains typical instrumentation for general orthopedic fracture fixation cases.

The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.

The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws and lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 5 mm to 20 mm. The lag screws and k-wires are used for fixation independent of the plates. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the k-wires are made of titanium alloy per ASTM F136. All plates and screws are provided sterile and non-sterile.