# K243760: OSSIOfiber® Suture Anchor 2.5-3.5 mm

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Apr 3, 2025 after 118 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: 13 generations back to K792022 (1979). 108 ancestors in all.
No later device cites it as a predicate yet.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180594: Knotless SutureTak Anchors, Arthrex, Inc. (2018) Summary page 5.
- K213415: OSSIOfiber Suture Anchor, OSSIO, Ltd. (2022) Summary page 5.

## Indications for use
The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, 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. Specific indications are listed below: » 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction * Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, Joint Capsule Closure * Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers * Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

Source page: https://510kreport.com/device/K243760
Methodology: https://510kreport.com/methodology