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The Extremity All Suture System is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below: 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 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

The Extremity All Suture System (EASS) includes the Griplasty™ System – Base of Thumb and Griplasty™ System – Micro, Mini and Small Suture Anchor. The system incorporates soft tissue fixation devices; 'all suture' anchors with an expandable push-in design, provided preloaded in an inserter handle with associated single-use instruments, and supplied sterile (ethylene oxide) for single use. The EASS anchors are constructed from a hollow braid with a suture component assembled through the hollow braid. All sutures, inclusive of suture line and anchor, are made with non-absorbable Ultra High Polyethylene (UHMWPE) per ASTM F2848. All needles are made with Stainless Steel per ASTM F899. The instrumentation is made stainless steel and medical grade Acrylonitrile Butadiene Styrene (ABS). The anchor and impacted into a pilot hole. The sutures are manually tensioned to set the anchor by bunching the suture sleeve. Griplasty" System – Base of Thumb: Comprises a suture anchor implant (with or without needles) and associated instrumentation for use in carpometacarpal (CMC) joint arthroplasty. Griplasty" System – Micro, Mini and Suture Anchor: Comprises a range of all suture anchor implants (with or without needles) and associated instrumentation for use in securing soft tissue to bone.

The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, osteotomies, and arthrodesis. appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler. The Field Orthopaedics BTES Plate Range and Plate Screws are in the fixation of fractures, osteotomies, and arthrodesis of the hand and other small bones. The system may be used in both adults and pediatric patients.

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates cleared in K200043. The BTES screw range consists of a range of screws intended for standalone use, and a range of screws intended to be used with the BTES plate range. The standalone screw range consists of 1.2 mm solid, partially threaded screws of various lengths; 1.5 – 5.0 mm cannulated, partially threaded screws in both headless and headed designs of various lengths; and 2.0 - 3.0 mm Cannulated, fenestrated, partially threaded screws in both headless and headed designs of various lengths. The range of screws intended to be used with the BTES plate range consists of 1.2, 1.5, and 2.0 mm solid, fully-threaded screws of various lengths. The purpose of this Special 510(k) device modification is to notify FDA of the sterile NX Nail System, which is a line extension to the BTES Screw Range described above and cleared in K200043. NX Nail implants are made from the same titanium alloy using the same manufacturing processes as BTES implants, are non-compressive in design, and are available in lengths ranging from 12 to 90 mm and diameters ranging from 2.0 to 5.0 mm. NX Nail implants are offered nonsterile and sterile (gamma radiation). This Special 510(k) also includes added instruments for implanting NX Nail devices. Materials: All BTES screws in the Screw Range are made with Titanium alloy ELI (as per ASTM F136). All plates are available as identical configurations in both Titanium alloy ELI (as per ASTM F136) and CP Titanium (ISO 5832-2). Instruments are made from medical grades stainless steel, anodized aluminum, and marked with epoxy resin.

The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, and arthrodesis, appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement or bone void filler. The Field Orthopaedics BTES Plate Range and Plate Screws are intended for use in the fixation of fractures, osteotomies and arthrodesis of the hand and other small bones. The system may be used in both adults and paediatric patients.

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates. The BTES screw range consists of a range of screws intended for standalone use, and a range of screws intended to be used with the BTES plate range. The standalone screw range consists of 1.2 mm solid, partially threaded screws of various lengths; 1.5 – 5.0 mm Cannulated, partially threaded screws in both headless and headed designs of various lengths; and 2.0 - 3.0 mm Cannulated, fenestrated, partially threaded screws in both headless and headed designs of various lengths. The range of screws intended to be used with the BTES plate range consists of 1.2, 1.5 and, 2.0 mm solid, fully-threaded screws of various lengths. The BTES plate range consists of a variety of configurations including straight, L, T, and H frames. Key features of the plate range include anatomical contouring, locking screw, rotational correction, and compression holes. The plate thickness ranges from 0.6 – 1.2 mm with a number of holes ranging from 1 – 16 holes. Materials: All screws in the screw range are made with Titanium ELI(as per ASTM F136). All plates are available as identical configurations in both Titanium ELI (as per ASTM F136) and CP Titanium (ISO 5832-2). The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.

The Field Orthopaedics Micro Screw System consists of the following kits with the following indications: The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm. The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.

The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit. The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw. The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion. Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136). All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138). The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.