Atlas FDA

PKC

19 FDA 510(k) clearances · Product code

167 daysmedian time to decision
274 days90th percentile
19clearances measured

FDA profile

Official device name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Replacement of the humeral head for total anatomic shoulder arthroplasty
Adverse events (MAUDE)
2021: 14 · 2022: 31 · 2023: 46 · 2024: 54 · 2025: 88 · 2026: 91
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FX V135 EASYTECH® Shoulder System (K254154)FX Shoulder Solutions, Inc.2026-05-01
AETOS Shoulder System Stemless Humeral Prosthesis (K252129)Smith & Nephew, Inc.2025-10-03
INHANCE INTACT™ (K243248)Depuy Ireland UC2024-12-23
OsseoFit Stemless Shoulder System (K241873)Zimmer, Inc.2024-12-11
AETOS Shoulder System Stemless Humeral Prosthesis (K240716)Smith & Nephew, Inc.2024-11-20
SMR Stemless Anatomic (K221758)Lima Corporate S.P.A.2023-03-17
Tornier Perform Humeral System – Stemless (K220418)Tornier, Inc.2022-09-14
Shoulder Innovations Total Shoulder System (K213615)Shoulder Innovations, Inc.2022-03-11
GLOBAL ICON Stemless Shoulder System (K212683)Depuy(Ireland)2022-01-19
Ignite Stemless Anatomic Shoulder System (K203108)Ignite Orthopedics, LLC2021-07-16
Easytech® Anatomical Shoulder System (K201391)Fx Shoulder USA, Inc.2021-02-16
Arthrex Eclipse Titanium Humeral Head (K203100)Arthrex, Inc.2020-11-20
Arthrex Eclipse Shoulder Prosthesis System (K201542)Arthrex, Inc.2020-07-08
AltiVate Anatomic Canal-Sparing (CS) Shoulder (K193226)Encore Medical L.P.2020-06-03
Exactech® Equinoxe® Stemless Humeral Components (K192097)Exactech, Inc.2020-04-29
Comprehensive Nano Stemless Shoulder (K182516)Biomet Manufacturing Corp2019-04-22
Exactech Equinoxe Stemless Shoulder (K173388)Exactech, Inc.2018-03-09
Sidus Stem-Free Shoulder (K171858)Zimmer GmbH2017-12-18
Simpliciti Shoulder System (K143552)Tornier, Inc.2015-03-04

Track PKC automatically

Every clearance here is in the API, with alerts when new ones post.