FDA product code · Orthopedic

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

Name: FDA decisions, review times, recalls and adverse event reports for product code QKW
Creator: 510(k) Report

QKWClass II21 CFR 888.3695510(k) required1 decision since 20220 recalls

1 FDA decision since 2022. No recall names this code.

A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of QKW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QKW

1in 2022

2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QKW

Too few QKW 510(k)s in any year since 2007 to give a median.

Recalls per year · QKW

No recall names QKW since 2007.

Adverse event reports per year · QKW

23in 2025

2007high 23 (2025) · low 0 (2007)2025

MAUDE reports naming product code QKW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	0	—	11
2024	0	—	8
2025	0	—	23
2026	0	—	—

FIG. 1 — QKW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QKW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

What has FDA decided in QKW lately?