Product Code: PKC


Products Classified as PKC

4684Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrainedShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4684Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrainedShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained [34059]21 CFR §888.3660 🔎

Pre-market Notifications for PKC

K220418Tornier Perform Humeral System – StemlessTornier, Inc.
K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.
K212683GLOBAL ICON Stemless Shoulder SystemDePuy (Ireland)
K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics LLC
K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.
K201391Easytech® Anatomical Shoulder SystemFX Shoulder USA, Inc.
K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical, L.P
K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.
K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp
K173388Exactech Equinoxe Stemless ShoulderExactech Inc
K171858Sidus Stem-Free ShoulderZimmer GmbH
K143552Simpliciti Shoulder SystemTORNIER, INC.

Global Unique Device Identification Database

00846832061440Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061433Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061426Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061419Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061402Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061396Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061389Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061372Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061365Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061358Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061341Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061334Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061327Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061310Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
00846832061303Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Maude Adverse Events

SIDUSZIMMER GMBH2020-01-06
HUMERAL ANCHOR UNCEMENTED SZIMMER GMBH2019-11-21
SIDUS STEM-FREE SHOULDER, HEAD DISTRACTORZIMMER GMBH2019-10-29
SIDUS HEAD EXTREMITIESZIMMER GMBH2019-09-05
SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, MZIMMER GMBH2019-08-19
SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16ZIMMER GMBH2019-08-19
SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, LZIMMER GMBH2019-08-16
COMPR NANO SLAP HAMMERZIMMER BIOMET, INC.2019-06-25
SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16ZIMMER GMBH2018-12-20
SIDUS STEM-FREE SHOULDER HUMERAL ANCHOR, UNCEMENTED, LZIMMER GMBH2018-12-20
SIDUS STEM-FREE SHOULDER HUMERAL HEAD, 46-16ZIMMER GMBH2018-12-20
SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, SZIMMER GMBH2018-10-19
UNKNOWN SIDUS COMPONENTZIMMER GMBH2018-06-14
SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-19ZIMMER GMBH2018-05-08
SIMPLICITI SHOULDER SYSTEMTORNIER INC.2017-03-27
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