# K974538: Meniscal Repair Device

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Mar 3, 1998 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925573 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955768: Biofix Biodegradable Meniscus Arrow System, Bioscience, Inc. (1996) Summary page 3.

## Indications for use
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.

Source page: https://510kreport.com/device/K974538
Methodology: https://510kreport.com/methodology