# K122954: Cincher-2.6 Suture Anchor Model FG-001

- Pathway: 510(k) (Traditional)
- Applicant: Foundry Newcoxi, Inc.
- Decided: Dec 19, 2012 after 85 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Bioraptor 2.3 PK: named in the summary without a submission number
- (no number) PushLock: named in the summary without a submission number
- (no number) Force Fiber: named in the summary without a submission number

## Indications for use
The Foundry NewcoXl Cincber-2.6 Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: 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 tenoddsis Foot and Ankle: Hallux valgus repairs; Medial or lateral instability repairs/reconstructions; Achilles tendon repairs/reconstructions; Midfoot reconstructions; Metatarsal ligament/tendon repairs/reconstruction; Bunionectomy Elbow, Wrist and Hand: Biceps tendon reattachment; Ulnar or radial collateral ligament reconstructions; Lateral epicondylitis repair; Tennis elbow repair; Scapholunate ligament reconstruction Knee: Extra-capsular repairs: Medial collateral ligament; Lateral collateral ligament; Posterior oblique ligament; Patellar realignment and tendon repairs; Vastus medialis obliquous advancement; liotibial band tenodesis The Foundry NewcoXil Cincher-2.6 Suture Anchor is intended for single-use only.

Source page: https://510kreport.com/device/K122954
Methodology: https://510kreport.com/methodology