Extremity Medical Calcaneal Osteotomy Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150309 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 Extremity Medical Calcaneal Osteotomy Device is a surgical instrument classified as a Screw, Fixation, Bone (Product Code HWC). It is designed for performing calcaneal osteotomies, a procedure involving controlled bone cuts to correct deformities or realign the heel bone, typically in orthopedic surgery. The device facilitates precise bone manipulation and stabilization during reconstructive procedures of the hindfoot.
This device is supplied sterile for single-use and is intended for use in an operating room setting. It has received FDA 510(k) clearance under Special Controls for orthopedic applications, with clearance granted on March 4, 2015. The device adheres to regulatory standards for Class II medical devices and is manufactured by Extremity Medical, LLC. No additional sterilization or reprocessing is required post-use.
Frequently asked questions
What is the Extremity Medical Calcaneal Osteotomy Device used for?
This device is designed specifically for performing calcaneal osteotomies, which involve controlled bone cuts to correct deformities or realign the heel bone. It is primarily used in orthopedic surgery during reconstructive procedures of the hindfoot, enabling precise manipulation and stabilization of the calcaneus.
How is the device supplied and intended for use?
The Extremity Medical Calcaneal Osteotomy Device is supplied sterile and is intended for single-use only. It is meant to be used in an operating room setting, where surgeons can perform controlled bone cuts without the need for additional sterilization or reprocessing after use.
Is the device reusable or single-use?
The device is explicitly designed for single-use only. It is supplied sterile, eliminating the need for reprocessing or reuse, which helps ensure patient safety and maintain sterility standards in surgical environments.
What regulatory clearance does the device have?
The device has received FDA 510(k) clearance under Special Controls for orthopedic applications. This clearance confirms that it meets regulatory standards for Class II medical devices and is suitable for its intended use in controlled bone cutting procedures.
What type of fixation does the device provide during surgery?
The device is classified as a Screw, Fixation, Bone (Product Code HWC), meaning it is engineered to provide secure fixation during calcaneal osteotomies. This stabilization helps maintain proper alignment of the heel bone during reconstructive procedures.
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: Calcaneal Osteotomy | Extremity Medical, Extremity Medical, K150309 - Extremity Medical Calcaneal Osteotomy Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150309 | Class II | Active |
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Manufacturer
- Manufacturer
- Extremity Medical, LLC
Sources (1)
- FDA 510(k) K150309 24 fields · synced Oct 1, 2026