(95 days)
The BIOSURE REGENESORB Interference Screw is indicated for the reattachment, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs
PCL repairs
Extra-capsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs
Vastus medialis obliquus advancement
Iliotibial band tenodesis
Shoulder
Acromioclavicular separation repairs
Biceps tenodesis
Foot and Ankle
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Flexor hullucis longus (FHL) Tendon transfers
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicylitis repair
Scapholunate ligament reconstruction
Tendon transfers
Carpometacarpal joint arthroplasty
NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.
The Smith & Nephew's BIOSURE REGENESORB interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The interference screw is provided sterile, for single use only.
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.
This document is a 510(k) premarket notification clearance letter from the FDA for the BIOSURE REGENESORB Interference Screw. It states that the device is "substantially equivalent" to legally marketed predicate devices.
While the document mentions "Mechanical testing data for insertion and pull out (fixation) testing demonstrates the BIOSURE REGENESORB interference screw is substantially equivalent to the currently marketed predicate devices," and "The in vitro degradation of the device is substantially equivalent to the predicate BIOSURE HA (K080358)," it does not provide specific details about:
- Acceptance criteria: No numerical or qualitative criteria are listed for any performance metrics.
- Reported device performance: Specific values for insertion force, pull-out strength, or degradation rates are not provided.
- Study design details: There is no information on sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or whether MRMC or standalone studies were conducted.
The document's purpose is to grant clearance based on substantial equivalence, not to present the detailed results of performance studies against specific acceptance criteria. To get the information you are looking for, you would typically need to consult the full 510(k) submission, which is not included in the provided text.
§ 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.