# K970316: Innovasive 8MM Ligament Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Apr 16, 1997 after 82 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
No predicates in its family tree.
5 later devices descend from it; 4 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Mitek 5 mm Ligament Anchor: named in the summary without a submission number

## Most influential descendants
- K980491: Innovasive Linx Tibial Ligament Fastener (1998), 1 descendant of its own
- K983056: Innovasive Tibial Fastener (1998), 0 descendants of its own
- K980334: Innovasive 10MM Linx HT Ligament Fastener (1998), 0 descendants of its own
- K974049: Innovasive Linx BT 10MM Ligament Fastener (1998), 0 descendants of its own
- K973323: Acl Clip-in (1997), 0 descendants of its own

## Indications for use
The Innovasive Devices 8mm Ligament Fastener is intended for ligament to bone reattachenent of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.

Source page: https://510kreport.com/device/K970316
Methodology: https://510kreport.com/methodology