Modification to HBS Headless Bone Screw
FDA 510(k) K101030 · Biopro, Inc.
510(k) numberK101030
Submission
- Device name
- Modification to HBS Headless Bone Screw
- Applicant
- Biopro, Inc.
Port Huron, MI, US - Received
- April 13, 2010
- Decision date
- June 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail SystemHSB · Traditional | 09/14/2017SE |
| K162674 | BioPro Foot Plating SystemsHRS · Traditional | 06/16/2017SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | 10/24/2013SE |
| K130298 | Biopro Kwick-Wire Universal Screw SystemJDW · Traditional | 06/18/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | 10/30/2012SE |
| K100761 | Biopro Polar HeadKWY · Traditional | 12/03/2010SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | 05/22/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | 03/18/2009SE |
| K082705 | Biopro Bipolar Head, Models 18130-18152KWY · Traditional | 12/15/2008SE |
| K081149 | Biopro Go-Ez ScrewHWC · Traditional | 08/05/2008SE |
Questions and answers
When was Modification to HBS Headless Bone Screw cleared by the FDA?
Modification to HBS Headless Bone Screw (K101030) received a 510(k) decision of Substantially Equivalent on June 3, 2010, 51 days after the submission was received.
What is the product code of K101030?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.