# K974049: Innovasive Linx BT 10MM Ligament Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Feb 18, 1998 after 117 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 1 generation back to K970316 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970316: Innovasive 8MM Ligament Fastener, Innovasive Devices, Inc. (1997) Summary page 2.
- (no number) Mitek Ligament Anchor: named in the summary without a submission number

## Indications for use
The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.

Source page: https://510kreport.com/device/K974049
Methodology: https://510kreport.com/methodology