Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthosoft Inc. (d/b/a) Zimmer CAS · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
241 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-06-04 | 28 | 0 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 | 90 | 0 |
| K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 | 22 | 0 |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 | 199 | 0 |
| K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024-10-18 | 28 | 0 |
| K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024-02-21 | 146 | 0 |
| K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 | 123 | 0 |
| K230567 | OptiVu™ ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 | 104 | 0 |
| K231162 | ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-05-23 | 29 | 0 |
| K230180 | Rosa Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-02-22 | 30 | 0 |
| K220733 | OptiVu ROSA MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-07-29 | 137 | 0 |
| K213708 | ROSA® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-04-22 | 149 | 0 |
| K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021-10-12 | 60 | 0 |
| K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020-06-05 | 88 | 0 |
| K192080 | iASSIST Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-11-05 | 95 | 0 |
| K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-30 | 28 | 0 |
| K183544 | Efficient Care 3D Planning | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-23 | 246 | 0 |
| K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 | 90 | 0 |
| K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-01-24 | 91 | 0 |
| K171269 | X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2017-12-28 | 241 | 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