Kyocera Medical Technologies, Inc.: FDA clearances and approvals
Kyocera Medical Technologies, Inc. has 16 FDA 510(k) clearances (first 2020, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time: 82 days. Since 2017 its median was 82 days, against 93 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 4 | 30 |
| 2021 | 2 | 94 |
| 2022 | 2 | 98 |
| 2023 | 1 | 29 |
| 2024 | 2 | 152 |
| 2025 | 4 | 193 |
| 2026 | 1 | 82 |
Review time against the same product codes
Since 2017, Kyocera Medical Technologies, Inc.'s cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Kyocera Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | OVD | 2026-07-15 | 82 |
| K242928 | Tesera-k SC System | OVE | 2025-04-10 | 198 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | LPH | 2025-04-10 | 272 |
| K242771 | Tesera-k PL System and Tesera-k XL System | MAX | 2025-03-20 | 188 |
| K243295 | Initia Knee System | JWH | 2025-01-13 | 87 |
| K243015 | Skyway Anterior Cervical Plate System | KWQ | 2024-11-05 | 39 |
| K232114 | TRIBRID® Unicompartmental Knee System | HSX | 2024-04-04 | 265 |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | 2023-04-21 | 29 |
| K223105 | Tesera-K SC System | OVE | 2022-12-22 | 83 |
| K212980 | Tesera-k ALIF System | OVD | 2022-01-07 | 112 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kyocera Medical Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kyocera Medical Technologies, Inc. have?
Kyocera Medical Technologies, Inc. has 16 FDA 510(k) clearances (first 2020, latest 2026), across 9 product codes in 1 review panel.
How long does FDA take to clear Kyocera Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kyocera Medical Technologies, Inc.'s cleared 510(k)s is 82 days. Since 2017: 82 days, versus 93 days for all cleared 510(k)s in the same product codes.
What devices does Kyocera Medical Technologies, Inc. make?
Its most frequent FDA product codes are 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).
Has Kyocera Medical Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kyocera Medical Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 16 Kyocera Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OVD, Kyocera Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.