# K971922: Innovasive 2.8MM and 3.5MM Roc EZ Suture Bone Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Aug 7, 1997 after 76 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.
106 later devices descend from it; 3 cite it directly.
0 of 107 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) 2.8mm and 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener: named in the summary without a submission number

## Most influential descendants
- K992458: RC Multisuture Bone Anchor, Model 4453/4454 (1999), 79 descendants of its own
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own

## Indications for use
SHOULDER Bankart repair Repair of rotator cuff tears capsular instability slap lesion repair acromio-clavicular separation capsule shift/capsulolabral reconstruction 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 mid-foot reconstructions. FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs BLADDER NECK SUSPENSION Rladder neck suspension for female urinary incontinence due to vrethial hypermebility.

Source page: https://510kreport.com/device/K971922
Methodology: https://510kreport.com/methodology