Orthosoft D/B/A Zimmer Cas: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Orthosoft D/B/A Zimmer Cas” (first 2021, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Since 2017 the median was 95 days, against 113 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 3 | 125 |
| 2022 | 2 | 105 |
| 2023 | 2 | 72 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthosoft D/B/A Zimmer Cas took a median 95 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Orthopedic (5)
- Radiology (2)
Most recent Orthosoft D/B/A Zimmer Cas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232533 | ROSA Partial Knee System | OLO | 2023-11-16 | 87 |
| K230243 | ROSA® Knee System | OLO | 2023-03-29 | 58 |
| K221928 | ROSA® Knee System | OLO | 2022-10-04 | 95 |
| K213033 | iASSIST Knee System | OLO | 2022-01-14 | 115 |
| K210998 | ROSA Hip System | LLZ | 2021-08-17 | 137 |
| K210653 | ONE Planner Hip | LLZ | 2021-07-07 | 125 |
| K210121 | ROSA Partial Knee System | OLO | 2021-04-19 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Orthosoft D/B/A Zimmer Cas.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Orthosoft, Inc. (14 510(k)s)
- Orthosoft Inc (D/B/A Zimmer Cas) (14 510(k)s)
- Orthosoft Inc. (d/b/a) Zimmer CAS (5 510(k)s)
- Orthosoft Inc. (D/B/A) Zimmer Cas) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthosoft D/B/A Zimmer Cas?
FDA lists 7 510(k) clearances under the applicant name “Orthosoft D/B/A Zimmer Cas” (first 2021, latest 2023), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthosoft D/B/A Zimmer Cas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthosoft D/B/A Zimmer Cas is 95 days. Since 2017: 95 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthosoft D/B/A Zimmer Cas?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 5); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 7 Orthosoft D/B/A Zimmer Cas clearances with predicates and recalls
- Run predicate analysis for product code OLO, Orthosoft D/B/A Zimmer Cas's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.