# K970423: Innovasive Roclet Bone Tunnel Augmentation Device

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Apr 30, 1997 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) 2mm GORE-TEX soft tissue patch: named in the summary without a submission number

## Most influential descendants
- K112296: Lateral Button (2011), 0 descendants of its own

## Indications for use
The intended use of the ROClet is to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.

Source page: https://510kreport.com/device/K970423
Methodology: https://510kreport.com/methodology