# K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Nov 4, 1996 after 67 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.
18 later devices descend from it; 4 cite it directly.
0 of 19 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) Mitek GII Anchor: named in the summary without a submission number

## Most influential descendants
- K060970: Axyaloop Nonabsorbable Bone Anchor (2006), 10 descendants of its own
- K083268: Tornier, Inc., Insite Suture Anchors (2009), 7 descendants of its own
- K110773: Tornier Insite FT Suture Anchor (2011), 5 descendants of its own
- K982963: Polymer Threaded Anchor / Suture Combination (1998), 4 descendants of its own
- K011985: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit (2001), 3 descendants of its own

## Indications for use
The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K963402
Methodology: https://510kreport.com/methodology