(75 days)
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.
Implantation of the fixation device is accomplished through arthroscopy or arthrotomy.
The Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C violet #2 at less than 0.01 wt.8.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The document is a 510(k) summary for a Meniscal Repair Device, detailing its intended use, description, and substantial equivalence to a predicate device. It includes regulatory correspondence from the FDA.
§ 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.