Company · US
Kyocera Medical Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2026 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System Kyocera Medical Technologies, Inc. | OVD |
| Apr 10, 2025 | K242928 | Tesera-k SC System Kyocera Medical Technologies, Inc. | OVE |
| Apr 10, 2025 | K242045 | Initia T3 Acetabular Hemispherical Shell System Kyocera Medical Technologies, Inc. | LPH |
| Mar 20, 2025 | K242771 | Tesera-k PL System and Tesera-k XL System Kyocera Medical Technologies, Inc. | MAX |
| Jan 13, 2025 | K243295 | Initia Knee System Kyocera Medical Technologies, Inc. | JWH |
| Nov 5, 2024 | K243015 | Skyway Anterior Cervical Plate System Kyocera Medical Technologies, Inc. | KWQ |
| Apr 4, 2024 | K232114 | TRIBRID® Unicompartmental Knee System Kyocera Medical Technologies, Inc. | HSX |
| Apr 21, 2023 | K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System Kyocera Medical Technologies, Inc. | OVD |
| Dec 22, 2022 | K223105 | Tesera-K SC System Kyocera Medical Technologies, Inc. | OVE |
| Jan 7, 2022 | K212980 | Tesera-k ALIF System Kyocera Medical Technologies, Inc. | OVD |
| Aug 30, 2021 | K212070 | KMTI S141 Lumbar Interbody Fusion System Kyocera Medical Technologies, Inc. | MAX |
| Apr 2, 2021 | K203472 | KMTI Hip Replacement System Kyocera Medical Technologies, Inc. | OQG |
| Jul 16, 2020 | K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc. | OQG |
| Apr 17, 2020 | K200709 | Kyocera Bipolar Hip System Kyocera Medical Technologies, Inc. | KWY |
| Mar 11, 2020 | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc. | OQG |
| Feb 4, 2020 | K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System Kyocera Medical Technologies, Inc. | OVD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||