ActivaScrew Cannulated COM
FDA 510(k) K261057 · Bioretec, Ltd.
510(k) numberK261057
Submission
- Device name
- ActivaScrew Cannulated COM
- Applicant
- Bioretec, Ltd.
Tampere, FI - Received
- March 31, 2026
- Decision date
- September 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| 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 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | OSSIO , Ltd. | 05/01/2026SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K133950 | Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)HTY · Special | 01/22/2014SE |
| K130716 | Bioretec Activascrew InterferenceMAI · Traditional | 08/28/2013SE |
| K080879 | Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm…HTY · Traditional | 06/24/2008SE |
| K081392 | Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinHWC · Special | 06/18/2008SE |
| K072848 | ActivascrewHWC · Special | 11/02/2007SE |
| K071863 | Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)HTY · Special | 08/31/2007SE |
| K062980 | ActivascrewHWC · Traditional | 11/22/2006SE |
| K061164 | ActivapinHTY · Traditional | 07/06/2006SE |
Questions and answers
When was ActivaScrew Cannulated COM cleared by the FDA?
ActivaScrew Cannulated COM (K261057) received a 510(k) decision of Substantially Equivalent on September 4, 2026, 157 days after the submission was received.
What is the product code of K261057?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.