enHAnce PEEK Bunion System
FDA 510(k) K253718 · Nvision Biomedical Technologies, Inc.
510(k) numberK253718
Submission
- Device name
- enHAnce PEEK Bunion System
- Applicant
- Nvision Biomedical Technologies, Inc.
San Antonio, TX, US - Received
- November 24, 2025
- Decision date
- April 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | 06/11/2025SE |
| 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 enHAnce PEEK Bunion System cleared by the FDA?
enHAnce PEEK Bunion System (K253718) received a 510(k) decision of Substantially Equivalent on April 1, 2026, 128 days after the submission was received.
What is the product code of K253718?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.