Atlas FDA

QHQ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Total Shoulder Arthroplasty System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Medical specialty
Orthopedic
Flags
Implant
FDA definition
To treat pain and lack of function in the shoulder.
Adverse events (MAUDE)
2020: 21 · 2021: 23 · 2023: 17 · 2024: 32 · 2025: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Arthrex Eclipse Shoulder Prosthesis System (K183194)Arthrex, Inc.2019-07-26

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