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: K110847, K111212, K142139, K153722, K183042, K191963, K200368, K201905, K212992, K243955, K251558
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.
- 3 Peg Mod Drill Guide Sz 1 Zimmer, Inc.
- 3 Peg Mod Drill Guide Sz 2-5 Zimmer, Inc.
- 32mm Glenosphere and Humeral Cup FX SOLUTIONS
- 32mm Glenosphere and Humeral Cup FX SOLUTIONS
- 32mm Glenosphere and Humeral Cup FX SOLUTIONS
- 32mm Glenosphere and Humeral Cup FX SOLUTIONS
- 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