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: K142139, K153602, K161189, K163397, K170893, K172054, K172456, K183042, K190286, K190911, K191963, K193560, K200368, K201905, K212569, K212800, K212992, K220452, K220792, K221758, K230315, K231112, K233408, K241143, K242813, K243826, K243955, K251184, K251558, K260802
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.
- 10 Deg 36mm Adj B-D Mini Sizer Biomet Orthopedics, LLC
- 3 Peg Mod Drill Guide Sz 1 Zimmer, Inc.
- 3 Peg Mod Drill Guide Sz 2-5 Zimmer, Inc.
- 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
- AEQUALIS TORNIER
- AEQUALIS TORNIER