# K980334: Innovasive 10MM Linx HT Ligament Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Apr 27, 1998 after 89 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.

## Indications for use
The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.

Source page: https://510kreport.com/device/K980334
Methodology: https://510kreport.com/methodology