Orthosoft Inc (D/B/A Zimmer Cas): FDA clearances and approvals
Orthosoft Inc (D/B/A Zimmer Cas) has 14 FDA 510(k) clearances (first 2017, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time: 93 days. Since 2017 its median was 93 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 241 |
| 2018 | 0 | — |
| 2019 | 5 | 91 |
| 2020 | 1 | 88 |
| 2021 | 1 | 60 |
| 2022 | 2 | 143 |
| 2023 | 3 | 30 |
| 2024 | 1 | 146 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Orthosoft Inc (D/B/A Zimmer Cas)'s cleared 510(k)s took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 5 | 5 |
| QHE | Shoulder Arthroplasty Implantation System | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| SBF | Orthopedic Augmented Reality | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 1 |
Review panels
- Orthopedic (12)
- Radiology (2)
Most recent Orthosoft Inc (D/B/A Zimmer Cas) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233199 | ROSA® Shoulder System | OLO | 2024-02-21 | 146 |
| K230567 | OptiVu ROSA® MxR | SBF | 2023-06-13 | 104 |
| K231162 | ROSA Hip System | LLZ | 2023-05-23 | 29 |
| K230180 | Rosa Knee System | OLO | 2023-02-22 | 30 |
| K220733 | OptiVu ROSA MxR | SBF | 2022-07-29 | 137 |
| K213708 | ROSA® Knee System | OLO | 2022-04-22 | 149 |
| K212560 | Signature ONE System | QHE | 2021-10-12 | 60 |
| K200615 | Signature ONE System | QHE | 2020-06-05 | 88 |
| K192080 | iASSIST Knee System | OLO | 2019-11-05 | 95 |
| K192074 | Signature ONE System | QHE | 2019-08-30 | 28 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthosoft Inc (D/B/A Zimmer Cas).
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 Orthosoft Inc (D/B/A Zimmer Cas) have?
Orthosoft Inc (D/B/A Zimmer Cas) has 14 FDA 510(k) clearances (first 2017, latest 2024), across 6 product codes in 2 review panels.
How long does FDA take to clear Orthosoft Inc (D/B/A Zimmer Cas)'s 510(k)s?
The median time from FDA receipt to decision across Orthosoft Inc (D/B/A Zimmer Cas)'s cleared 510(k)s is 93 days. Since 2017: 93 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Orthosoft Inc (D/B/A Zimmer Cas) make?
Its most frequent FDA product codes are OLO (Orthopedic Stereotaxic Instrument, 5); QHE (Shoulder Arthroplasty Implantation System, 3); LLZ (System, Image Processing, Radiological, 2).
Has Orthosoft Inc (D/B/A Zimmer Cas) had device recalls?
openFDA lists no recalls under a recalling firm name matching Orthosoft Inc (D/B/A Zimmer Cas). Related entities may recall under other names.
Next steps
- See all 14 Orthosoft Inc (D/B/A Zimmer Cas) clearances with predicates and recalls
- Run predicate analysis for product code OLO, Orthosoft Inc (D/B/A Zimmer Cas)'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.