HBS Headless Bone Screw
510(k) K030302
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030302 | Date8 Aug 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The HBS Headless Bone Screw is a metallic orthopedic fixation device classified as a bone screw (Product Code HWC). It features a headless, dual-threaded design intended for internal fixation of bone fractures and osteotomies, providing compression to stabilize osseous fragments and promote healing.
Implanted by orthopedic surgeons in clinical or surgical settings, these cannulated titanium alloy screws are supplied in Mini and Standard series. The device is regulated under FDA 510(k) clearance (K030302) and is intended for single-use implantation. Storage and handling follow standard sterile orthopedic implant protocols.
Questions
AI-generated answers, 19 Sep 2026
What are the key differences between the Mini and Standard series of the HBS Headless Bone Screw, and how might a surgeon choose between them?
The HBS Headless Bone Screw comes in two series: Mini and Standard, which likely differ in size and intended application for smaller or larger bone fragments. The Mini series is designed for smaller bones or limited spaces, while the Standard series is suited for larger fixation needs. Surgeons typically select based on the anatomical site, fracture size, and stability requirements—smaller bones (e.g., wrist, ankle) may use the Mini series, whereas larger bones (e.g., tibia, femur) may require the Standard series for optimal compression and stabilization.
Is the HBS Headless Bone Screw reusable, or is it intended for single-use only? How should it be handled to maintain sterility?
The HBS Headless Bone Screw is intended for single-use implantation only, as explicitly stated in the device description. To maintain sterility, it should be handled using standard sterile orthopedic implant protocols—packaged in sterile packaging, opened only in a sterile field, and used immediately after removal from its sterile barrier. Reuse is not recommended to prevent contamination or compromise of fixation integrity.
What material is the HBS Headless Bone Screw made from, and why is this material choice important for orthopedic fixation?
The HBS Headless Bone Screw is made from titanium alloy, a material chosen for its biocompatibility, corrosion resistance, and lightweight properties. Titanium alloy is ideal for orthopedic fixation because it integrates well with bone tissue, reduces the risk of adverse reactions, and provides sufficient strength to maintain stability during the healing process without adding excessive weight to the implant site.
How is the dual-threaded design of the HBS Headless Bone Screw intended to benefit bone healing compared to traditional screws?
The dual-threaded design of the HBS Headless Bone Screw creates a tighter grip on bone fragments, allowing for compression across the fracture site when implanted. This compression promotes better alignment of bone fragments and enhances the healing process by reducing micromotion, which can delay or disrupt osseous union. Traditional screws may not provide the same level of compression, making this design particularly useful for stabilizing osteotomies or complex fractures where stability is critical.