OSSIOfiber Suture Anchor
FDA 510(k)Class II (US FDA 510(k))
by Ossio Ltd
Identifiers
- 510(k) Number
- K251309 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 fastener used for soft tissue fixation in orthopedic applications. It is designed to provide initial pull-out resistance and maintain strength during surgical procedures involving soft tissue repair.
This device is supplied sterile and intended for single-use. It is authorized under FDA 510(k) clearance (K251309) and classified as a Class II medical device for orthopedic use.
Frequently asked questions
What types of orthopedic procedures is the OSSIOfiber® Suture Anchor designed to assist with?
The OSSIOfiber® Suture Anchor is specifically designed for soft tissue fixation in orthopedic applications. It provides initial pull-out resistance and maintains strength during surgical procedures involving soft tissue repair, such as rotator cuff repairs, labral repairs, or other soft tissue reattachments in joints like the shoulder.
Is the OSSIOfiber® Suture Anchor reusable, or is it intended for single-use only?
The OSSIOfiber® Suture Anchor is explicitly intended for single-use only. This ensures sterility and safety for each patient, as it is supplied sterile and should not be reused after a single surgical procedure.
How is the OSSIOfiber® Suture Anchor supplied, and what should I consider for storage?
The OSSIOfiber® Suture Anchor is supplied sterile, ready for immediate use in surgical settings. Since it is single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use. Always follow manufacturer guidelines for storage to maintain sterility and functionality.
What regulatory pathway was followed for the approval of the OSSIOfiber® Suture Anchor?
The OSSIOfiber® Suture Anchor was authorized under the FDA 510(k) clearance process, specifically with clearance number K251309. It is classified as a Class II medical device for orthopedic use, indicating it has undergone a review to demonstrate substantial equivalence to a predicate device already on the market.
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 ..., OSSIO , Ltd. FDA 510 (k) Orthopedic Products - Latest 2026, OSSIOfiber® Suture Anchors: Intelligent Soft Tissue Repair
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251309 | Class II | Active |
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Manufacturer
- Manufacturer
- Ossio Ltd
- FDA Applicant
- OSSIO , Ltd.
Sources (1)
- FDA 510(k) K251309 24 fields · synced Sep 19, 2026