(64 days)
The Bio-Mini Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to secure soft tissue, such as ligaments, tendons, or joint capsules, to the bone, thereby stabilizing the damaged area during the healing period.
The Linvatec Bio-Mini-Revo™ suture anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with one non-absorbable, braided, ultrahigh molecular weight polyethylene suture. The Bio-Mini-Revo™ suture anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.
The requested information is not available in the provided document. The document is a 510(k) summary for a medical device (Bio-Mini Revo Suture Anchor) and primarily discusses its substantial equivalence to predicate devices, device description, and intended use. It does not contain details about specific acceptance criteria or a study proving the device meets them in the way described in the request (e.g., performance metrics, sample sizes, expert involvement, and ground truth establishment). The document is a regulatory submission for premarket notification, not a clinical or performance study report.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.