# K992377: RC Tack

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Oct 8, 1999 after 85 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 K970089 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970089: Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener, Innovasive Devices, Inc. (1997) Summary page 1.
- K971922: Innovasive 2.8MM and 3.5MM Roc EZ Suture Bone Fastener, Innovasive Devices, Inc. (1997) Summary page 1.

## Most influential descendants
- K994269: Titan RC Tack (2000), 0 descendants of its own

## Indications for use
The 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/K992377
Methodology: https://510kreport.com/methodology