510(k) Report

FDA product code · Orthopedic

Condylar Plate Fixation Implant

JDPClass II21 CFR 888.3030510(k) required2 decisions since 20111 recall

2 FDA decisions since 2011. 1 recall names this code; it is not Class I. The most-cited predicate is K110354, named by 6 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 JDP 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 · JDP

1in 2017

2011: 12017: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDP

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

Recalls per year · JDP

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JDP

41in 2025

2007: 12008: 12009: 12010: 12011: 22012: 212013: 832014: 552015: 972016: 1172017: 462018: 562019: 492020: 562021: 792022: 612023: 292024: 302025: 41
2007high 117 (2016) · low 1 (2007)2025

MAUDE reports naming product code JDP, 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—01
20080—01
20090—01
20100—01
20111—02
20120—021
20130—183
20140—055
20150—097
20160—0117
20171—046
20180—056
20190—049
20200—056
20210—079
20220—061
20230—029
20240—030
20250—041
20260—0—
FIG. 1 — JDP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JDP? 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 888.3030.