IO Fix Hand, IO Fix Foot, Extremity Medical Screw System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101700 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 IO Fix Hand and IO Fix Foot are orthopedic fixation devices designed for internal fixation of fractures in the hand and foot. These systems use intramedullary screws to stabilize long bones, such as the metacarpals, phalanges, and metatarsals, providing mechanical support during the healing process.
The IO Fix Hand and IO Fix Foot systems are supplied as reusable surgical instruments and single-use screw components. They are intended for use in orthopedic procedures under sterile conditions, with sizes tailored for specific anatomical applications. The system holds FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD)
Frequently asked questions
Are the IO Fix Hand and IO Fix Foot systems reusable or single-use, and how should they be handled during surgery?
The IO Fix Hand and IO Fix Foot systems include reusable surgical instruments and single-use screw components. The screws are designed for one-time use under sterile conditions, while the instruments can be reused after proper cleaning and sterilization between cases. This setup ensures both cost efficiency for the reusable tools and safety for patients with the single-use screws.
What types of fractures are these devices intended to stabilize, and how do they work?
The IO Fix Hand and IO Fix Foot systems are designed to stabilize fractures in long bones of the hand and foot, specifically the metacarpals, phalanges, and metatarsals. They use intramedullary screws inserted into the bone marrow cavity to provide mechanical support, helping to align the fracture fragments and promote proper healing during the recovery process.
How are the IO Fix Hand and IO Fix Foot systems regulated, and what pathway was used for FDA clearance?
The IO Fix Hand and IO Fix Foot systems hold FDA 510(k) clearance under the Traditional pathway, meaning they were determined to be substantially equivalent to a legally marketed predicate device. They also comply with the Medical Device Directive (MDD), ensuring adherence to European regulatory standards. The clearance was granted by the Orthopedic (OR) Advisory Committee in 2010.
Are there different sizes available for the IO Fix systems, and how are they tailored to specific anatomical applications?
Yes, the IO Fix Hand and IO Fix Foot systems come with sizes tailored to specific anatomical applications in the hand and foot. The screws are designed to fit the unique dimensions of metacarpals, phalanges, and metatarsals, ensuring proper fixation and stability for different fracture types and patient anatomies.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101700 | Class II | Active |
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Manufacturer
- Manufacturer
- Extremity Medical, LLC
Sources (2)
- FDA 510(k) K101700 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 28, 2026