HBS Headless Bone Screw
FDA 510(k)Class II (US FDA 510(k))
by Biopro, Inc.
Identifiers
- 510(k) Number
- K101030 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 HBS Headless Bone Screw is a fixation device designed for hand, foot, and small bone fragment repairs or fusions. It is indicated for use in osteotomy fixation, joint arthrodesis, and post-traumatic fragment repair.
This cannulated screw is manufactured from titanium in compliance with ASTM F136-02a and is available in 2.5mm and 3.0mm diameters. The device has received FDA 510(k) clearance under K101030.
Frequently asked questions
What clinical procedures is the HBS Headless Bone Screw indicated for?
This device is designed for use in hand, foot, and small bone fragment repairs or fusions. Specific clinical applications include osteotomy fixation, joint arthrodesis, and the repair of post-traumatic bone fragments.
What material is used to manufacture the HBS Headless Bone Screw?
The screw is manufactured from titanium in compliance with the ASTM F136-02a standard, which ensures the material meets the necessary specifications for surgical implant applications.
What are the available size options for this cannulated screw?
The HBS Headless Bone Screw is currently available in two diameter sizes: 2.5mm and 3.0mm, allowing clinicians to select the appropriate size for their specific small bone fixation requirements.
What is the regulatory status of this device?
The HBS Headless Bone Screw has received FDA 510(k) clearance under K101030, confirming that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
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: MODIFICATION TO HBS HEADLESS BONE SCREW by BIOPRO, INC. | FDA 510 (k ..., Modification To Hbs Headless Bone Screw 510 (k) FDA Premarket ..., PDF K101030 - Modification to Hbs Headless Bone Screw, www.accessdata.fda.gov, FDA Browser - Cleared 510 (K) - MODIFICATION TO HBS HEADLESS BONE SCREW ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101030 | Class II | Active |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA 510(k) K101030 24 fields · synced Sep 22, 2026