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510(k) Data Aggregation
K Number
K122954Device Name
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
Manufacturer
Date Cleared
2012-12-19
(85 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FOUNDRY NEWCO XI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Foundry NewcoXI Cincher-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 tenodesis
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
- Bicens 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
- Iliotibial band tenodesis
The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for single-use only.
Device Description
The Cincher-2.6 Suture Anchor consists of a PEEK polymer suture anchor preloaded with a #2 polyethylene suture, loaded on an insertion tool. The Cincher-2.6 Suture Anchor is designed to facilitate fixation of soft tissue to bone. The design allows the surgeon to adjust the suture tension on the soft tissue after insertion of the anchor into bone. The device is provided sterile.
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