FDA product code · Orthopedic

Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented

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

MJTClass IIIPathway set case by case3 decisions since 19970 recalls

3 FDA decisions since 1997. No recall names this code.

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 MJT 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 · MJT

FDA has decided no MJT device since 2007.

Median 510(k) review, days · MJT

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

Recalls per year · MJT

No recall names MJT since 2007.

Adverse event reports per year · MJT

6in 2022

2007high 39 (2018) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	0
2009	—	1
2010	—	0
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	11
2017	—	26
2018	—	39
2019	—	0
2020	—	2
2021	—	0
2022	—	6
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in MJT? 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

Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented

What has FDA decided in MJT lately?