# K982996: Polymer Obl SB Anchor / Suture Combination

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Mar 4, 1999 after 189 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950592 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener, Innovasive Devices, Inc. (1996) Summary page 1.
- K950592: Accessories Foe Orthopedic Surgical Procedures, Eare Consulting Service (1995) Summary page 1.

## Indications for use
This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended for use only for the fixation of non-absorbable synthetic sutures for the following indications. The Polymer Cinch SB Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. Shoulder: 1. Bankhart Repair 2. SLAP Lesion Repair 3. Acromio-clavicular separation 4. Rotator Cuff Repair S. Capsule and Capsulolabral Reconstruction 6. Biceps Tenodesis 7. Deltoid Repair Hand, Wrist, Elbow: 1. Scapholunate ligament reconstruction 2. Ulnar Collateral Ligament Reconstruction 3. Lateral Collateral Ligament Reconstruction 4. Biceps Tendon Reattachment 5. Elbow Medial/Lateral Repair of Tendons in the Elbow Foot: 1. Hallux Valgus Reconstruction 2. Mid and Forefoot Reconstruction Knee: 1. medial collateral ligament 2. Jateral collateral ligament 3. posterior oblique ligament b 4. Joint capsule closure 5. Iitiotibial band tendonesis 6. VMO Advancement Urinary: Bladder Neck Suspension

Source page: https://510kreport.com/device/K982996
Methodology: https://510kreport.com/methodology