# K994269: Titan RC Tack

- Pathway: 510(k) (Special)
- Applicant: Innovasive Devices, Inc.
- Decided: Jan 10, 2000 after 21 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K970089 (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)
- K992377: RC Tack, Innovasive Devices, Inc. (1999) Summary page 1.

## Indications for use
The Titan RC Tack is intended for soft tissue to bone fixation for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

Source page: https://510kreport.com/device/K994269
Methodology: https://510kreport.com/methodology