# K213415: OSSIOfiber Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Mar 28, 2022 after 160 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K792022 (1979). 90 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193503: Arthrex SwiveLock Suture Anchor, Arthrex, Inc. (2020) Summary page 4.

## Most influential descendants
- K251309: OSSIOfiber® Suture Anchor (2025), 1 descendant of its own
- K254055: OSSIOfiber® Suture Anchor (2026), 0 descendants of its own
- K243760: OSSIOfiber® Suture Anchor 2.5-3.5 mm (2025), 0 descendants of its own

## Indications for use
The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow 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. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 – 5.5 Anchors only). Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

Source page: https://510kreport.com/device/K213415
Methodology: https://510kreport.com/methodology