(257 days)
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for use in the following applications:
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
- Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
- Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
The Tornier Insite™ FT Biocomposite Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded biocomposite (85/15 PLLA/βTCP) anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.
The Tornier Insite™ FT Biocomposite Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.
The provided document describes the Tornier Insite™ FT Biocomposite Suture Anchor and its regulatory submission (K122635). It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML-based medical device.
The document pertains to a traditional medical device (a suture anchor), and the "nonclinical testing" described refers to mechanical, material, and biocompatibility tests typical for such devices, aimed at demonstrating substantial equivalence to predicate devices, rather than AI performance metrics.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it is not present in the given text. The input does not describe an AI/ML device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.