(87 days)
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene suture. The Bio Mini-Revo suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions: with or without colorant D&C violet #2.
This document is a 510(k) summary for the ConMed Linvatec Bio Mini-Revo Suture Anchor. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a new, unique device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted because such a study is not described in this 510(k) submission.
Key points from the document that explain why the requested information isn't available:
- Type of Submission: This is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with defined acceptance criteria.
- Focus on Substantial Equivalence: The document explicitly states: "The ConMed Linvatec Bio Mini-Revo Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K053561, K072291 and K061863."
- Lack of Performance Data: There are no sections detailing specific performance metrics, clinical study results, or statistical analyses against defined acceptance criteria that would typically be found in a study proving a device meets certain performance thresholds.
- Device Type: The device is a Bioabsorbable Suture Anchor. The 510(k) generally relies on the established safety and performance of similar predicate devices and material characterization (e.g., bioabsorption properties of the PLA Copolymer) rather than a comparative study of its clinical performance against specific metrics.
In summary, this 510(k) submission successfully established substantial equivalence, allowing the device to be marketed, but does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance) that would be provided for a device with a novel mechanism requiring such demonstration.
§ 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.