Activapin
FDA 510(k) K061164 · Bioretec, Ltd.
510(k) numberK061164
Submission
- Device name
- Activapin
- Applicant
- Bioretec, Ltd.
Tampere, FI - Received
- April 26, 2006
- Decision date
- July 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | 09/04/2026SE |
| 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 |
Questions and answers
When was Activapin cleared by the FDA?
Activapin (K061164) received a 510(k) decision of Substantially Equivalent on July 6, 2006, 71 days after the submission was received.
What is the product code of K061164?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.