Impact PEEK Union Nail System
FDA 510(k) K250646 · Nvision Biomedical Technologies
510(k) numberK250646
Submission
- Device name
- Impact PEEK Union Nail System
- Applicant
- Nvision Biomedical Technologies
San Antonio, TX, US - Received
- March 4, 2025
- Decision date
- June 11, 2025
- 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
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 |
| 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 |
| K231905 | Electro-Spec Steri-CapsHTY · Traditional | Electro-Spec, Inc. | 08/14/2023SE |
More from Electro-Spec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253718 | enHAnce PEEK Bunion SystemHRS · Traditional | 04/01/2026SE |
| K260291 | Vortex5 Tailor's Bunion Correction SystemHRS · Traditional | 03/25/2026SE |
| K253423 | ToeJack MIS Bunion SystemHRS · Traditional | 11/18/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | 09/19/2025SE |
| K250613 | SnapHammer Hammertoe Correction SystemHWC · Special | 04/02/2025SE |
| K242896 | Caliber Intramedullary Fixation SystemHWC · Traditional | 02/05/2025SE |
| K243231 | Trigon PEEK HA WedgesPLF · Special | 11/08/2024SE |
| K240250 | 3D Printed PEEK Interbody SystemMAX · Traditional | 09/17/2024SE |
| K231453 | SnapHammer Hammertoe Correction SystemHWC · Traditional | 02/16/2024SE |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | 01/26/2024SE |
Questions and answers
When was Impact PEEK Union Nail System cleared by the FDA?
Impact PEEK Union Nail System (K250646) received a 510(k) decision of Substantially Equivalent on June 11, 2025, 99 days after the submission was received.
What is the product code of K250646?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.