FDA product code · Orthopedic

Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

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

HTGClass II21 CFR 888.3580510(k) required2 decisions since 19770 recalls

2 FDA decisions since 1977. 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 HTG 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 · HTG

FDA has decided no HTG device since 2007.

Median 510(k) review, days · HTG

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

Recalls per year · HTG

No recall names HTG since 2007.

Adverse event reports per year · HTG

5in 2018

2007high 171 (2008) · low 0 (2016)2025

MAUDE reports naming product code HTG, 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	—	80
2008	—	171
2009	—	153
2010	—	147
2011	—	123
2012	—	54
2013	—	39
2014	—	13
2015	—	6
2016	—	0
2017	—	0
2018	—	5
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HTG? 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, Knee, Hemi-, Patellar Resurfacing, Uncemented

What has FDA decided in HTG lately?