510(k) Report

510(k) · Cleared

Cleared

Healey Revision Component System

K921139510(k) TraditionalCleared Jul 1, 1992113-day reviewClass III21 CFR 888.3320

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

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

Cleared on Jul 1, 1992 after a 113-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 1, 1992
Review
113 days
Class
Class III
Product code
JDL
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2000: 1 descendant cleared1990200020102020
  1. This deviceK921139 Healey Revision Component SystemBiomet, Inc. · 1992
  2. Descendant · cites it directly · 1 of its ownK990032 Modular Protusio CupBiomet, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK992359 MRS-TitanRotec Medizintechnik GmbH · 2000

Most influential descendants

Showing 2 of 2 · See all
  • K990032Modular Protusio CupBiomet, Inc. · 1999 · cites it directly1descendant
  • K992359MRS-TitanRotec Medizintechnik GmbH · 2000 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921139Healey Revision Component SystemBiomet, Inc.1992—
+1K990032Modular Protusio CupBiomet, Inc.19991
+2K992359MRS-TitanRotec Medizintechnik GmbH2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
FIG. 1 — Lineage of K921139, 1992–2000Source: FDA 510(k) summaries, read by 510(k) Report · 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.

Planning a device in JDL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990032Modular Protusio CupBiomet, Inc.19991

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K990032 (Biomet, Inc., 1999) has gone furthest, with 1 descendant of its own.

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 Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K921139 · printed Nov 4, 2026

Cite this page

510(k) Report. “K921139: Healey Revision Component System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921139

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