510(k) Report

FDA product code · Orthopedic

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

JDLClass III21 CFR 888.3320PMA required45 decisions since 19775 recalls

45 FDA decisions since 1977. 5 recalls name this code, 0 of them Class I. The most-cited predicate is K922561, named by 11 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 JDL 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 · JDL

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDL

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

Recalls per year · JDL

1in 2010

2009: 22010: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JDL

16in 2025

2007: 792008: 672009: 1042010: 1982011: 2712012: 3382013: 4962014: 5192015: 4662016: 2992017: 3362018: 2052019: 1402020: 942021: 682022: 492023: 322024: 272025: 16
2007high 519 (2014) · low 16 (2025)2025

MAUDE reports naming product code JDL, 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
20071—079
20081—067
20090—2104
20100—1198
20110—0271
20120—0338
20130—0496
20140—0519
20150—0466
20160—0299
20170—0336
20180—0205
20190—0140
20200—094
20210—068
20220—049
20230—032
20240—027
20250—016
20260—1—
FIG. 1 — JDL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JDL? 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 888.3320.