510(k) Report

FDA product code · Orthopedic

Prosthesis, Hip, Femoral Component, Cemented, Metal

JDGClass II21 CFR 888.3360510(k) required59 decisions since 19769 recalls

59 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 187 days (half between 187 and 187). 9 recalls name this code, 0 of them Class I. The most-cited predicate is K992234, named by 4 later devices.

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 JDG 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 · JDG

1in 2022

2018: 12020: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDG

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

Recalls per year · JDG

4in 2021

2009: 22013: 32021: 4
2007high 4 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDG

263in 2025

2007: 282008: 192009: 382010: 372011: 252012: 492013: 842014: 1452015: 3912016: 3832017: 3282018: 4472019: 3332020: 1,0462021: 1,2062022: 8862023: 2892024: 3002025: 263
2007high 1,206 (2021) · low 19 (2008)2025

MAUDE reports naming product code JDG, 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—028
20080—019
20090—238
20100—037
20110—025
20120—049
20130—384
20140—0145
20150—0391
20160—0383
20170—0328
20181—0447
20190—0333
20201—01,046
20210—41,206
20221—0886
20230—0289
20240—0300
20250—0263
20260—0—
FIG. 1 — JDG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JDG? 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

Related product codes

Other codes under 21 CFR 888.3360.