# K954338: Innovasive 1.9MM Roc Suture Bone Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Mar 21, 1996 after 185 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Ethicon USP #2/¢ braided polyester suture with suture button: named in the summary without a submission number

## Indications for use
The Innovasive Devices 1.9mm ROC Suture Bone Fastener is intended for the reattachment of the ulnar collateral and lateral collateral ligaments in the thumb and the scapholunate ligament in the wrist.

Source page: https://510kreport.com/device/K954338
Methodology: https://510kreport.com/methodology