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: K102072, K110047, K121277, K131264, K131459, K142134, K180348, K191424, K203811, K213982
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 |
|---|---|---|---|---|
| 2024-07-30 | VAI | Voluntary action indicated | GSource, LLC | 2 |
| 2024-07-30 | VAI | Voluntary action indicated | GSource, LLC | 2 |
- 1/3 COMPOSITE RING, LARGE Biomet Orthopedics, LLC
- 1/3 COMPOSITE RING, MEDIUM Biomet Orthopedics, LLC
- 1/3 COMPOSITE RING, SMALL Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/4 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/4 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC