Modification to: Inion Otps Biodegradable Pin
FDA 510(k) K050275 · Inion , Ltd.
510(k) numberK050275
Submission
- Device name
- Modification to: Inion Otps Biodegradable Pin
- Applicant
- Inion , Ltd.
Tampere, FI - Received
- February 7, 2005
- Decision date
- March 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code HTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | 11/07/2025SE |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…HBW · Traditional | 07/11/2025SE |
| K203105 | Inion CompressOn ScrewHWC · Traditional | 01/13/2021SE |
| K191764 | Inion BioRestoreMQV · Special | 07/31/2019SE |
| K151360 | Inion Spinal Graft Containment SystemOJB · Traditional | 10/06/2015SESU |
| K133932 | Inion FreedompinHTY · Traditional | 04/11/2014SE |
| K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)HWC · Traditional | 02/27/2013SE |
| K122890 | Inion CPS Orbital PlatesJEY · Traditional | 01/29/2013SE |
| K090177 | Inion Biorestore Biodegradable Bone Graft SubstituteMQV · Special | 02/20/2009SE |
| K071810 | Inion Spinal Graft Containment SystemOJB · Traditional | 07/11/2008SESU |
Questions and answers
When was Modification to: Inion Otps Biodegradable Pin cleared by the FDA?
Modification to: Inion Otps Biodegradable Pin (K050275) received a 510(k) decision of Substantially Equivalent on March 7, 2005, 28 days after the submission was received.
What is the product code of K050275?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.