# K982963: Polymer Threaded Anchor / Suture Combination

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Nov 20, 1998 after 88 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K963402 (1996). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972326: Peba Anchor/Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 1.
- K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener, Innovasive Devices, Inc. (1996) Summary page 1.

## Most influential descendants
- K011985: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit (2001), 3 descendants of its own
- K042038: MTF Allograft Anchor (2004), 1 descendant of its own
- K061498: Allofix Anchor, 5.0 MM Anchor (2006), 0 descendants of its own
- K053339: Allofix Anchor (2006), 0 descendants of its own

## Indications for use
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications: Shoulder: Bankart lesion repairs SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs Foot and Ankle: Hallux Valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand: Scapholunate ligament reconstructions Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment Extra-capsular repairs: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs, including vastus medialis obliquus advancement The Cinch Threaded 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. The Cinch Threaded Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indication: Urinary: Bladder Neck Suspension

Source page: https://510kreport.com/device/K982963
Methodology: https://510kreport.com/methodology