# K993453: Meniscus Arrow, Models 531110, 531113, 531116

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Ltd.
- Decided: Nov 9, 1999 after 27 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 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 1.

## Most influential descendants
- K012334: Contour Meniscus Arrow, Models 541110, 541113, and 541116 (2001), 1 descendant of its own
- K041128: Suture Arrow (2004), 0 descendants of its own

## Indications for use
The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. “red-red” and “red-white” zones) in conjunction with immobilization during healing.

Source page: https://510kreport.com/device/K993453
Methodology: https://510kreport.com/methodology
