Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bodycad Laboratories, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
245 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253300 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2025-10-28 | 29 | 0 |
| K250394 | Fine TTO™ | Bodycad Laboratories, Inc. | 2025-10-21 | 251 | 0 |
| K250923 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2025-08-21 | 147 | 0 |
| K241356 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024-09-05 | 114 | 0 |
| K240703 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024-04-12 | 29 | 0 |
| K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024-02-09 | 31 | 0 |
| K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023-06-02 | 28 | 0 |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-10-12 | 81 | 0 |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-08-20 | 60 | 0 |
| K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021-07-28 | 61 | 0 |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-03-12 | 84 | 0 |
| K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020-03-25 | 90 | 0 |
| K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019-12-05 | 132 | 0 |
| K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-10-08 | 160 | 0 |
| K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-01-17 | 245 | 0 |
| K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017-03-29 | 90 | 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