510(k) Report

FDA product code · Orthopedic

Mesh, Surgical, Acetabular, Hip, Prosthesis

JDJClass II21 CFR 878.3300510(k) required7 decisions since 19890 recalls

7 FDA decisions since 1989. No recall names this code. The most-cited predicate is K962541, named by 5 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 JDJ 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 · JDJ

FDA has decided no JDJ device since 2007.

Median 510(k) review, days · JDJ

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

Recalls per year · JDJ

No recall names JDJ since 2007.

Adverse event reports per year · JDJ

2in 2025

2007: 12008: 12010: 52011: 62012: 102013: 182014: 152015: 122016: 52017: 22018: 152019: 342020: 142021: 142022: 82024: 12025: 2
2007high 34 (2019) · low 0 (2009)2025

MAUDE reports naming product code JDJ, 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—00
20100—05
20110—06
20120—010
20130—018
20140—015
20150—012
20160—05
20170—02
20180—015
20190—034
20200—014
20210—014
20220—08
20230—00
20240—01
20250—02
20260—0—
FIG. 1 — JDJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JDJ? 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

Which predicates do JDJ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K962541Reflection Acetabular Reinforcement RingsSmith & Nephew Richards, Inc. · 19965cite it
  • K962007Protrusion CagesDepuy, Inc. · 19964cite it
  • K970957Osteonics Restoration Acetabular RingOsteonics Corp. · 19971cites it
  • K925883Osteonics Microstructured Acetabular ComponentsOsteonics Corp. · 19931cites it
  • K890450Intermedics Apr (TM) II Femoral ComponentIntermedics Orthopedics · 19891cites it

Which JDJ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K963940Exeter MeshHowmedica, Inc. · 19971generation

What has FDA decided in JDJ lately?

  • K972760Link, Acetabular Revision Mesh CupLink America, Inc. · 1997
  • K970957Osteonics Restoration Acetabular RingOsteonics Corp. · 1997
  • K963940Exeter MeshHowmedica, Inc. · 1997
  • K962541Reflection Acetabular Reinforcement RingsSmith & Nephew Richards, Inc. · 1996
  • K962007Protrusion CagesDepuy, Inc. · 1996
  • K925883Osteonics Microstructured Acetabular ComponentsOsteonics Corp. · 1993

All 7 JDJ decisions →

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