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Smith & Nephew Arthroscopic Surgical Instruments—Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.

The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following: Shoulder: Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis. Foot/Ankle: Hallux Valgus, Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers. Elbow/Hand/Wrist: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon/Repair. Knee: Medial or Lateral Collateral ligament, Posterior oblique ligament, Vasus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair.

The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee - ACL Repairs, PCL Repairs, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs, Vastus medialis obliquous advancement, Iliotibial band tenodesis. Shoulder - Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis. Foot and Ankle - Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus (FLH), Tendon Transfers. Elbow, Wrist, and Hand - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Reconstruction.

The Smith & Nephew HA-PLA Interference Screw is indicated for fixation of bone-tendonbone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery.

The Cannu-Flex Silk Screw is an Interference Screw, indicated for tendon/ligament graft fixation.

The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. The screw is indicated for single use only.

RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.

The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems are accessory devices and take on the classification of the device(s) with which they are used. The Drivers, Taps, Screw Starters, and Routers are all manufactured from medical grade Stainless Steel.

The provided text describes a 510(k) summary for "Smith & Nephew Interference Screw Systems Instruments." This document primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/software devices.

The product described is a set of surgical instruments made of medical-grade stainless steel, used to facilitate the implantation of interference screws in arthroscopic surgery. The FDA clearance is based on comparison to existing legally marketed predicate devices, asserting that the instruments utilize the same raw materials, manufacturing processes, intended use, and nature of body contact.

Therefore, I cannot populate the requested tables and sections regarding acceptance criteria and performance study details from the provided text. The document states:

• "The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems have the same intended use, technological and performance characteristics as the legally marketed predicate devices. The product designs are in conformance with the recognized consensus standards identified in this submission and do not raise any new issues of safety and efficacy."

This statement indicates that performance was established through substantial equivalence to existing devices and compliance with consensus standards, rather than through a direct performance study with specific acceptance criteria as might be seen for novel devices, especially those involving AI or new performance claims.

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