# K190915: OsteoFab Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Performance Materials, Inc.
- Decided: Jul 3, 2019 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
Longest line of descent: 7 generations back to K961555 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only, Cayenne Medical, Inc. (2012) Summary page 4.

## Indications for use
The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair. Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis. Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair. Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair. Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.

Source page: https://510kreport.com/device/K190915
Methodology: https://510kreport.com/methodology