510(k) Report

510(k) · Cleared

Recalled · 2006

Metal Backed Acetabular Component

K950542510(k) TraditionalCleared May 25, 1995107-day reviewClass III21 CFR 888.3320Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encore Orthopedics, Inc. · JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Cleared on May 25, 1995 after a 107-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided
May 25, 1995
Review
107 days
Class
Class III
Product code
JDL
Recalls
1
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K950542Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 12, 2006Not classifiedZ-0799-06OtherVoids in the porous coating of a component used in total hip replacement surgery.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JDL devices

JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

Recent decisions in JDL

The JDL category page

  • K073499Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008
  • K070785Dynasty Acetabular SystemWrightmedicaltechnologyinc · 2007
  • K061844Dynasty Acetabular Shell and Cocr Acetabular LinerWrightmedicaltechnologyinc · 2006
  • K051995Profemur Renaissance Hip StemWrightmedicaltechnologyinc · 2005
  • K051348Conserve Total Femoral HeadWrightmedicaltechnologyinc · 20052 recalls

https://510kreport.com/device/K950542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950542: Metal Backed Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950542

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026