OSSIOfiber Compression Screws
FDA 510(k)Class II (US FDA 510(k))
by Ossio Ltd
Identifiers
- 510(k) Number
- K193660 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OSSIOfiber Compression Screws are bio-integrative, metal-free orthopedic fixation devices designed for bone stabilization. These screws are engineered to provide compressive force at fracture sites, facilitating alignment and promoting bone healing without the use of metallic implants. Their unique composition allows for gradual integration into bone tissue, reducing the risk of hardware-related complications such as loosening or corrosion. This device falls under the category of orthopedic fixation screws, offering an alternative to traditional metal-based solutions for long bone fractures or osteotomies.
These screws are supplied sterile and intended for single-use in orthopedic surgical procedures. They are compatible with standard surgical techniques and can be used in various anatomical locations, including long bones such as the femur, tibia, and humerus. The device is classified under product code HWC and has received FDA clearance via a 510(k) submission (K193660), affirming its substantial equivalence to predicate devices. Storage instructions specify maintaining sterility until use, with no specific MRI safety restrictions noted in the available data.
Frequently asked questions
What are the OSSIOfiber Compression Screws used for?
The OSSIOfiber Compression Screws are designed for orthopedic fixation in long bone fractures or osteotomies, such as those in the femur, tibia, or humerus. Unlike traditional metal screws, they provide compressive force at fracture sites to promote alignment and healing while integrating into bone tissue over time. This reduces risks like loosening or corrosion associated with metallic implants.
Are the OSSIOfiber Compression Screws metal-free and how does that benefit patients?
Yes, the OSSIOfiber Compression Screws are entirely metal-free, composed of a unique bio-integrative material. This eliminates concerns about corrosion, allergic reactions, or long-term hardware failure, which can occur with traditional metal screws. The material also allows for gradual integration into bone, potentially improving stability and healing outcomes.
How are the OSSIOfiber Compression Screws supplied and what are their storage requirements?
The screws are supplied sterile and intended for single-use only in surgical procedures. To maintain sterility, they must be stored according to the manufacturer’s instructions until use. No specific MRI safety restrictions are noted in the available data, but standard surgical precautions should be followed.
Can these screws be used in any anatomical location, or are there specific limitations?
The OSSIOfiber Compression Screws are compatible with standard surgical techniques and can be used in various anatomical locations, particularly long bones like the femur, tibia, and humerus. While they offer flexibility in application, their suitability for other sites should be evaluated on a case-by-case basis by the surgeon, considering the specific clinical context and anatomical constraints.
What regulatory approval does the OSSIOfiber Compression Screws hold, and how does that affect their use?
The OSSIOfiber Compression Screws have received FDA clearance through a 510(k) submission (K193660), confirming their substantial equivalence to predicate devices. This clearance indicates that the device meets regulatory standards for safety and effectiveness as determined by the FDA. Clinicians and facilities should verify compliance with local regulations and institutional protocols before use.
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® Bio-Integrative Metal-Free Compression Screws, OSSIO® Products: Metal-Free Bone Fixation Solutions, http://discover.ossio.io/compression-screw/, PDF OSSIOfiber Compression Screws - 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 | K193660 | Class II | Active |
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Manufacturer
- Manufacturer
- Ossio Ltd
- FDA Applicant
- OSSIO , Ltd.
Sources (1)
- FDA 510(k) K193660 24 fields · synced Oct 1, 2026