# K980491: Innovasive Linx Tibial Ligament Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Apr 29, 1998 after 79 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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) Soft Tissue Screw and Washer System: named in the summary without a submission number

## Most influential descendants
- K983056: Innovasive Tibial Fastener (1998), 0 descendants of its own

## Indications for use
The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.

Source page: https://510kreport.com/device/K980491
Methodology: https://510kreport.com/methodology