Orthosoft Inc. (d/b/a) Zimmer CAS: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Orthosoft Inc. (d/b/a) Zimmer CAS” (first 2024, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 days. Since 2017 the median was 28 days, against 91 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 |
|---|---|---|
| 2024 | 1 | 28 |
| 2025 | 1 | 199 |
| 2026 | 3 | 28 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthosoft Inc. (d/b/a) Zimmer CAS took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| QHE | Shoulder Arthroplasty Implantation System | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Orthosoft Inc. (d/b/a) Zimmer CAS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261510 | Signature ONE System | QHE | 2026-06-04 | 28 |
| K260582 | ROSA® Shoulder System | OLO | 2026-05-21 | 90 |
| K260104 | Signature ONE System | QHE | 2026-02-04 | 22 |
| K251314 | Rosa® Knee System | OLO | 2025-11-13 | 199 |
| K242864 | ROSA® Knee System | OLO | 2024-10-18 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Orthosoft Inc. (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 D/B/A Zimmer Cas (7 510(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 Inc. (d/b/a) Zimmer CAS?
FDA lists 5 510(k) clearances under the applicant name “Orthosoft Inc. (d/b/a) Zimmer CAS” (first 2024, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthosoft Inc. (d/b/a) Zimmer CAS?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthosoft Inc. (d/b/a) Zimmer CAS is 28 days. Since 2017: 28 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthosoft Inc. (d/b/a) Zimmer CAS?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 3); QHE (Shoulder Arthroplasty Implantation System, 2).
Next steps
- See all 5 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. 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.