1.5MM Bone Fixation Kit
FDA 510(k) K012000 · Bionx Implants, Ltd.
510(k) numberK012000
Submission
- Device name
- 1.5MM Bone Fixation Kit
- Applicant
- Bionx Implants, Ltd.
Tampere, FI - Received
- June 27, 2001
- Decision date
- July 18, 2001
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K030388 | Impact Suture Anchor. Model 433510HWC · Traditional | 04/24/2003SE |
| K023022 | Nugen FX ScrewHWC · Special | 10/04/2002SE |
| K020056 | Duet Suture AnchorHWC · Traditional | 06/26/2002SE |
| K011569 | Biosorbfx O/M 2.0/2/4 SystemJEY · Traditional | 02/22/2002SE |
| K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214HWC · Special | 11/21/2001SE |
| K013057 | Biocuff,C, Models 236018, 236028, 236036MAI · Special | 10/12/2001SE |
| K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116MAI · Special | 09/19/2001SE |
| K012001 | SmartscrewHWC · Special | 07/18/2001SE |
| K010983 | Plla PinHTY · Special | 06/13/2001SE |
| K010554 | Meniscus Arrow Sheath #CN1000A; Smartscrew Acl Sheath #SSA2000AHWC · Traditional | 05/25/2001SE |
Questions and answers
When was 1.5MM Bone Fixation Kit cleared by the FDA?
1.5MM Bone Fixation Kit (K012000) received a 510(k) decision of Substantially Equivalent on July 18, 2001, 21 days after the submission was received.
What is the product code of K012000?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.