510(k) K232114
- Device
- TRIBRID® Unicompartmental Knee System
- Applicant
- Kyocera Medical Technologies, Inc.
- 510(k) number
- K232114
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-04
- Date received
- 2023-07-14
- Regulation
- 888.3520
- Classification name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jason Lansdown
- Address
- 1200 California St. Suite 210 Redlands CA US 92374 92374
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 2242737
- 3005180920
- 2133928
- 3009241418
- 3013176080
- 3017410889
- 3021008900
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- 3010039400
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- 3030412764
- 1057425
- 1645151
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- 3035366890
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- 3006783837
- 3011187779
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- 3005706667
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- 3011274144
- 3012319330
- 2249615
- 8043792
- 1219602
- 1424263
- 3016851379
- 2528981
- 9616671
- 3003998208
- 3010375065
- 9613369
- 3005551626
- 3014302784
- 3008262872
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841523171743 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171590 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171606 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171613 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171620 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171637 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171644 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171651 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171668 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171675 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171682 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171699 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171705 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171712 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171729 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171736 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523170753 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171750 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171767 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171774 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171781 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171798 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171804 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171811 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171828 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171835 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171842 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171859 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171866 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
| 00841523171873 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | 2024-05-08 |
Other 510(k) Records For Product Code HSX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| K251834 | Persona Partial Knee | Zimmer Biomet | 2025-08-15 |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025-07-24 |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025-07-01 |
| K241260 | ACTIFY Unicondylar Knee System | Globus Medical, Inc. | 2024-12-06 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024-10-30 |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024-10-07 |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023-03-10 |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022-06-16 |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022-06-02 |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | 2021-12-16 |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021-11-16 |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-10-12 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 |