OSSIOfiber Suture Anchor
FDA 510(k)Class II (US FDA 510(k))
by Ossio Ltd
Identifiers
- 510(k) Number
- K254055 FDA 510(k)
- FDA Product Code
- MAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OSSIOfiber Suture Anchor is a biodegradable soft tissue fixation device classified as a fastener. It is designed to secure soft tissue to bone or soft tissue to soft tissue using suture attachment, providing a reliable anchor point for orthopedic and sports medicine procedures. The device is engineered to offer predictable pull-out resistance and maintain strength during and after insertion, facilitating stable tissue repair.
This device is intended for single-use in orthopedic settings and is supplied sterile. It is classified as a Class II medical device under FDA regulations (888.3030) and holds a 510(k) clearance (K254055) for traditional premarket notification. The anchor is available in sizes such as 2.5mm and 5.5mm, and is designed for use in procedures requiring secure soft tissue fixation. Storage and handling should follow manufacturer guidelines to ensure sterility and performance integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OSSIOfiber® Suture Anchors: Intelligent Soft Tissue Repair, OSSIOfiber® 2.5mm Suture Anchor - OSSIO - Naturally Transformative Bone ..., OSSIOfiber® Suture Anchors - OrthoPediatrics, PDF OSSIOfiber 5.5mm Suture Anchor - orthopediatrics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254055 | Class II | Active |
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Manufacturer
- Manufacturer
- Ossio Ltd
- FDA Applicant
- OSSIO , Ltd.
Sources (1)
- FDA 510(k) K254055 24 fields · synced Sep 20, 2026