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: K102924, K120794, K131135, K131633, K162726, K173824, K182516, K183039, K191963, K193038, K202024, K202716, K210899, K212737, K241817
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.
- TT MB Peg LIMACORPORATE SPA
- TT MB Peg LIMACORPORATE SPA
- 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
- 3PEGS GLENOID CEMENT PRESSURIZER LIMACORPORATE SPA
- 3PEGS GLENOID CEMENT PRESSURIZER LIMACORPORATE SPA
- ACUMED Acumed LLC
- ACUMED Acumed LLC