(78 days)
The Arthrex Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone. Specifically; Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 mm.
The provided text is a 510(k) summary for a medical device called the "Bio-Post and Washer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) is not present in the provided document.
The document states that the device is "substantially equivalent" to predicate devices, meaning that "basic features and intended uses are the same. Minor differences... do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device." This implies that the device's performance aligns with that of already approved devices, making specific, quantifiable acceptance criteria and a standalone study proving those criteria less relevant for this type of regulatory submission.
§ 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.