# K983056: Innovasive Tibial Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Oct 13, 1998 after 42 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: 2 generations back to K970316 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980491: Innovasive Linx Tibial Ligament Fastener, Innovasive Devices, Inc. (1998). Our OCR of the scanned summary read K990491, FDA’s number for Angio-CT Miyabi (Siemens Medical Solutions USA, Inc.), decided Apr 5, 1999, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “LinX Tibial Ligament Fastener”.
- K962194: Mli Soft Tissue Screw & Washer System, Medicinelodge, Inc. (1996) Summary page 2.

## Indications for use
The Tibial Fastener is 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/K983056
Methodology: https://510kreport.com/methodology