Company · CA
Orthosoft Inc (D/B/A Zimmer Cas)
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 13 |
| QHE | Shoulder Arthroplasty Implantation System | 6 |
| LLZ | System, Image Processing, Radiological | 4 |
| SBF | Orthopedic Augmented Reality | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 2026 | K261510 | Signature ONE System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | QHE |
| May 21, 2026 | K260582 | ROSA® Shoulder System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | OLO |
| Feb 4, 2026 | K260104 | Signature ONE System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | QHE |
| Nov 13, 2025 | K251314 | Rosa® Knee System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | OLO |
| Oct 18, 2024 | K242864 | ROSA® Knee System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | OLO |
| Feb 21, 2024 | K233199 | ROSA® Shoulder System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Dec 12, 2023 | K232425 | Signature ONE System Orthosoft Inc. (D/B/A) Zimmer Cas), CA | QHE |
| Nov 16, 2023 | K232533 | ROSA Partial Knee System Orthosoft D/B/A Zimmer Cas, CA | OLO |
| Jun 13, 2023 | K230567 | OptiVu ROSA® MxR Orthosoft Inc (D/B/A Zimmer Cas), CA | SBF |
| May 23, 2023 | K231162 | ROSA Hip System Orthosoft Inc (D/B/A Zimmer Cas), CA | LLZ |
| Mar 29, 2023 | K230243 | ROSA® Knee System Orthosoft D/B/A Zimmer Cas, CA | OLO |
| Feb 22, 2023 | K230180 | Rosa Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Oct 4, 2022 | K221928 | ROSA® Knee System Orthosoft D/B/A Zimmer Cas, CA | OLO |
| Jul 29, 2022 | K220733 | OptiVu ROSA MxR Orthosoft Inc (D/B/A Zimmer Cas), CA | SBF |
| Apr 22, 2022 | K213708 | ROSA® Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Jan 14, 2022 | K213033 | iASSIST Knee System Orthosoft D/B/A Zimmer Cas, CA | OLO |
| Oct 12, 2021 | K212560 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | QHE |
| Aug 17, 2021 | K210998 | ROSA Hip System Orthosoft D/B/A Zimmer Cas, CA | LLZ |
| Jul 7, 2021 | K210653 | ONE Planner Hip Orthosoft D/B/A Zimmer Cas, CA | LLZ |
| Apr 19, 2021 | K210121 | ROSA Partial Knee System Orthosoft D/B/A Zimmer Cas, CA | OLO |
| Jun 5, 2020 | K200615 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | QHE |
| Nov 5, 2019 | K192080 | iASSIST Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Aug 30, 2019 | K192074 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | QHE |
| Aug 23, 2019 | K183544 | Efficient Care 3D Planning Orthosoft Inc (D/B/A Zimmer Cas), CA | LLZ |
| Jun 5, 2019 | K190595 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | KWT |
| Jan 24, 2019 | K182964 | ROSA Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Dec 28, 2017 | K171269 | X-PSI Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | JWH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||