TRIBRID® Unicompartmental Knee System
FDA 510(k) K232114 · Kyocera Medical Technologies, Inc.
510(k) numberK232114
Submission
- Device name
- TRIBRID® Unicompartmental Knee System
- Applicant
- Kyocera Medical Technologies, Inc.
Redlands, CA, US - Received
- July 14, 2023
- Decision date
- April 4, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K260796 | Tahoe Unicondylar Knee System with TiNbN OvercoatHSX · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 04/02/2026SE |
| 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 |
| K221292 | Uni Knee Resurfacing SystemHSX · Traditional | Overture Resurfacing, Inc. | 03/10/2023SE |
More from Overture Resurfacing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | 07/15/2026SE |
| K242928 | Tesera-k SC SystemOVE · Traditional | 04/10/2025SE |
| K242045 | Initia T3 Acetabular Hemispherical Shell SystemLPH · Traditional | 04/10/2025SE |
| K242771 | Tesera-k PL System and Tesera-k XL SystemMAX · Traditional | 03/20/2025SE |
| K243295 | Initia Knee SystemJWH · Traditional | 01/13/2025SE |
| K243015 | Skyway Anterior Cervical Plate SystemKWQ · Traditional | 11/05/2024SE |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Special | 04/21/2023SE |
| K223105 | Tesera-K SC SystemOVE · Traditional | 12/22/2022SE |
| K212980 | Tesera-k ALIF SystemOVD · Traditional | 01/07/2022SE |
| K212070 | KMTI S141 Lumbar Interbody Fusion SystemMAX · Special | 08/30/2021SE |
Questions and answers
When was TRIBRID® Unicompartmental Knee System cleared by the FDA?
TRIBRID® Unicompartmental Knee System (K232114) received a 510(k) decision of Substantially Equivalent on April 4, 2024, 265 days after the submission was received.
What is the product code of K232114?
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.