# K972356: Innovasive 2.3MM Roc EZ Suture Bone Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Aug 26, 1997 after 62 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) 2.8mm/3.5mm Innovasive Devices ROC EZ Suture Bone Fastener: named in the summary without a submission number
- (no number) 1.9mm/2.3mm Innovasive Devices ROC Suture Bone Fastener: named in the summary without a submission number
- (no number) 1.8mm Mitek Mini Anchor: named in the summary without a submission number

## Indications for use
ANKLE Lateral instability Medial instability Achilles tendon reconstruction and repair Midfoot reconstructions HAND Ulnar or lateral collateral ligament reconstruction WRIST Scapholunate ligament reconstruction FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs

Source page: https://510kreport.com/device/K972356
Methodology: https://510kreport.com/methodology