Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Orthosoft D/B/A Zimmer Cas — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

95 daysmedian FDA review time
137 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas2023-11-16870
K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas2023-03-29580
K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas2022-10-04950
K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas2022-01-141150
K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas2021-08-171370
K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas2021-07-071250
K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas2021-04-19900

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