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
- K170518
Cited as predicate by: K180377, K190385, K191535, K193543, K200762, K201149, K213069, K231236, K241387
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.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-03-08 | VAI | Voluntary action indicated | In2bones USA, LLC | 3 |
| 2019-03-08 | VAI | Voluntary action indicated | In2bones USA, LLC | 3 |
- """USTAR II Knee System """ UNITED ORTHOPEDIC CORP.
- 10.5MM CANNULATED DILATOR Biomet Orthopedics, LLC
- 10MM CANNULATED DILATOR Biomet Orthopedics, LLC
- 11MM CANNULATED DILATOR Biomet Orthopedics, LLC
- 36MM BRIDGEBACK RMR Zimmer, Inc.
- 37MM BRIDEBACK RMR Zimmer, Inc.
- 38MM BRIDGEBACK RMR Zimmer, Inc.
- 39MM BRIDGEBACK RMR Zimmer, Inc.
- 3MM RATTLER DRIVER Biomet Orthopedics, LLC
- 40MM BRIDGEBACK RMR Zimmer, Inc.
- 40mm Head Pusher Zimmer, Inc.
- 41MM BRIDGEBACK RMR Zimmer, Inc.