# K955768: Biofix Biodegradable Meniscus Arrow System

- Pathway: 510(k) (Traditional)
- Applicant: Bioscience, Inc.
- Decided: Mar 4, 1996 after 73 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: 1 generation back to K925573 (1993). 2 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925573: Acufex T-Bar, Acufex Microsurgical, Inc. (1993) Summary page 1.
- K942442: Acufex T-Fix Delivery System, Acufex Microsurgical, Inc. (1994) Summary page 1.
- (no number) Davis & Geck Maxon Monofilament Polyglyconate Synthetic Absorbable Surgical Sutures (Maxon sutures): named in the summary without a submission number

## Most influential descendants
- K993453: Meniscus Arrow, Models 531110, 531113, 531116 (1999), 2 descendants of its own
- K012334: Contour Meniscus Arrow, Models 541110, 541113, and 541116 (2001), 1 descendant of its own
- K053492: Bioduct (2007), 0 descendants of its own
- K031714: Inion Trinion Biodegradable Meniscus Screw (2004), 0 descendants of its own
- K041128: Suture Arrow (2004), 0 descendants of its own

## Indications for use
The BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., “red-red” and “red-white” area) in conjunction with appropriate immobihization.

Source page: https://510kreport.com/device/K955768
Methodology: https://510kreport.com/methodology