Tahoe Unicondylar Knee System with TiNbN Overcoat
FDA 510(k) K260796 · Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
510(k) numberK260796
Submission
- Device name
- Tahoe Unicondylar Knee System with TiNbN Overcoat
- Applicant
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
El Dorado Hills, CA, US - Received
- March 11, 2026
- Decision date
- April 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3520
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261609 | Freedom Partial Knee SystemHSX · Traditional | Maxx Orthopedics, Inc. | 08/04/2026SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | Signature Orthopaedics Pty, Ltd. | 12/16/2025SE |
| K251834 | Persona Partial KneeHSX · Traditional | Zimmer Biomet | 08/15/2025SE |
| K251618 | MOTO Partial Knee System ExtensionHSX · Traditional | Medacta International S.A. | 07/24/2025SE |
| K251453 | Arthrex iBalance Partial Knee SystemHSX · Traditional | Arthrex, Inc. | 07/01/2025SE |
| K241260 | ACTIFY Unicondylar Knee SystemHSX · Traditional | Globus Medical, Inc. | 12/06/2024SE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX · Traditional | Smith & Nephew, Inc. | 10/30/2024SE |
| K242746 | OvertureTi Knee Resurfacing SystemTMHSX · Special | Overture Orthopaedics | 10/07/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | Kyocera Medical Technologies, Inc. | 04/04/2024SE |
| K221292 | Uni Knee Resurfacing SystemHSX · Traditional | Overture Resurfacing, Inc. | 03/10/2023SE |
More from Overture Resurfacing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252846 | TaperSet Hip SystemLPH · Special | 11/20/2025SE |
Questions and answers
When was Tahoe Unicondylar Knee System with TiNbN Overcoat cleared by the FDA?
Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796) received a 510(k) decision of Substantially Equivalent on April 2, 2026, 22 days after the submission was received.
What is the product code of K260796?
The FDA product code is HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3520.