# K151314: CinchLock Flex Knotless Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Pivot Medical
- Decided: Jul 23, 2015 after 66 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131769: Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MM, Pivot Medical, Inc. (2013) Summary page 4.

## Recalls of this device
- Jan 29, 2025 · Class II · Z-1328-2025: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
- Apr 12, 2016 · Class II · Z-1635-2016: Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.

## Indications for use
HIP: Hip capsule repair, Acetabular labrum reattachment SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis

Source page: https://510kreport.com/device/K151314
Methodology: https://510kreport.com/methodology