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: K191146, K191698, K192799, K193394, K201391, K210790, K213117, K222482, K222936, K240278, K254154
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.
- 3PEGS GLENOID CEMENT PRESSURIZER LIMACORPORATE SPA
- 3PEGS GLENOID CEMENT PRESSURIZER LIMACORPORATE SPA
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ACUMED Acumed LLC
- ACUMED Acumed LLC
- ACUMED Acumed LLC