# K970089: Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Mar 25, 1997 after 74 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.
82 later devices descend from it; 2 cite it directly.
0 of 83 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) Innovasive Devices ROC 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
The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER 1. Repair of rotator cuff tears 2. capsular instability 3. slap lesion repair 4. acromio-clavicular separation 5. capsule shift/capsulolabral reconstruction 6. biceps tenodesis 7. deltoid repair KNEE 1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure. 2. Patellar ligament and tendon avulsion repairs. 3. Extra-capsular reconstruction, ITB tenodesis ANKLE 1. Lateral instability 2. Medial instability 3. Achilles tendon reconstruction and repair 4. Mid-foot reconstructions FOOT 1. Hallux valgus reconstruction BLADDER NECK SUSPENSION 1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K970089
Methodology: https://510kreport.com/methodology