Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kyocera Medical Technologies, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
265 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tes | Kyocera Medical Technologies, Inc. | 2026-07-15 | 82 | 0 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 | 198 | 0 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025-04-10 | 272 | 0 |
| K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025-03-20 | 188 | 0 |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | 2025-01-13 | 87 | 0 |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024-11-05 | 39 | 0 |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | 2024-04-04 | 265 | 0 |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | 2023-04-21 | 29 | 0 |
| K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022-12-22 | 83 | 0 |
| K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022-01-07 | 112 | 0 |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | 2021-08-30 | 59 | 0 |
| K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | 2021-04-02 | 128 | 0 |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies | Kyocera Medical Technologies, Inc. | 2020-07-16 | 28 | 0 |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | 2020-04-17 | 30 | 0 |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, | Kyocera Medical Technologies, Inc. | 2020-03-11 | 30 | 0 |
| K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) Syste | Kyocera Medical Technologies, Inc. | 2020-02-04 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda