# K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Jan 28, 1999 after 107 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.
22 later devices descend from it; 7 cite it directly.
0 of 23 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) RCI Screw: named in the summary without a submission number

## Most influential descendants
- K032167: Bio-Intrafix Tibial Screw and Sheath (2003), 15 descendants of its own
- K063577: Femoral Intrafix Screw and Sheath (2007), 7 descendants of its own
- K122123: 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw 8-10MM X 30 MM Intrafix Peek Tapered (2012), 5 descendants of its own
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) (2013), 4 descendants of its own
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (2013), 3 descendants of its own

## Indications for use
The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

Source page: https://510kreport.com/device/K983560
Methodology: https://510kreport.com/methodology