Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
Cited as predicate by: K121563, K122185, K122305, K123619, K123705, K130128, K131647, K141377, K142761, K152893, K153725, K170359, K171273, K172551, K172857, K180973, K182321, K190834, K192656, K201657, K241472
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- USTAR II Knee System UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.