# K252022: OSSIOfiber® Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Aug 19, 2025 after 50 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: 10 generations back to K961555 (1996). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202535: Arthrex FastThread Interference Screw, Arthrex, Inc. (2020) Summary page 5.
- K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw, Depuy Mitek (2024) Summary page 5.

## Indications for use
The OSSIOfiber® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; Specifically: • Shoulder: Rotator Cuff Repairs, 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, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle • Knee: Repair/Reconstruction of the Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band Tenodesis, MPFL • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

Source page: https://510kreport.com/device/K252022
Methodology: https://510kreport.com/methodology