510(k) Report

FDA product code · Orthopedic

Total Shoulder Arthroplasty System

QHQClass II21 CFR 888.3660510(k) required1 decision since 20190 recalls

1 FDA decision since 2019. No recall names this code. The most-cited predicate is K183194, named by 4 later devices.

To treat pain and lack of function in the shoulder.

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 QHQ 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 · QHQ

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QHQ

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

Recalls per year · QHQ

No recall names QHQ since 2007.

Adverse event reports per year · QHQ

27in 2025

2019: 102020: 212021: 232022: 92023: 172024: 322025: 27
2007high 32 (2024) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—010
20200—021
20210—023
20220—09
20230—017
20240—032
20250—027
20260—0—
FIG. 1 — QHQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QHQ? 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

Which predicates do QHQ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 20194cite it

Which QHQ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 20197generations

What has FDA decided in QHQ lately?

  • K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019

The one QHQ decision →

Related product codes

Other codes under 21 CFR 888.3660.

KWS Prosthesis, Shoulder, Semi-Constrained…PKC Prosthesis, Total Anatomic Shoulder…PHX Shoulder Prosthesis, Reverse ConfigurationQHE Shoulder Arthroplasty Implantation SystemPAO Prosthesis, Shoulder, Semi-Constrained…