# K972326: Peba Anchor/Suture Combination

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Feb 6, 1998 after 228 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
488 later devices descend from it; 9 cite it directly.
0 of 489 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) Zimmer Statak 2.5 Anchor: named in the summary without a submission number
- (no number) Arthrex Corkscrew 5.0 mm Anchor: named in the summary without a submission number

## Most influential descendants
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor (2006), 477 descendants of its own
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (2006), 283 descendants of its own
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew (2007), 227 descendants of its own
- K061154: Kinsa Suture Anchor (2006), 162 descendants of its own
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew (2009), 159 descendants of its own

## Recalls of this device
- Dec 30, 2019 · Class II · Z-1273-2020: Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture th

## 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 Cinch Series 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 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 Knee: 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 obliquous advancement

Source page: https://510kreport.com/device/K972326
Methodology: https://510kreport.com/methodology