510(k) Report

510(k) · Cleared

Cleared

M2A/C2A Acetabular System

K042841510(k) TraditionalCleared Dec 21, 200468-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 Dec 21, 2004 as substantially equivalent to K993438 (Biomet, Inc., 2000) and 2 other predicates after a 68-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided
Dec 21, 2004
Review
68 days
Class
Class III
Product code
JDL
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K861114 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2012: 1 descendant clearedK861114 · Mallory/Head - PF Acetabular Component · Biomet, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K861114 · Mallory/Head - PF Acetabular Component · Biomet, Inc. · 19860
  1. Root · 1 generation backK861114 Mallory/Head - PF Acetabular ComponentBiomet, Inc. · 1986
  2. This deviceK042841 M2A/C2A Acetabular SystemBiomet, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK113271 Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K861114Mallory/Head - PF Acetabular ComponentBiomet, Inc.1986—
0 (this device)K042841M2A/C2A Acetabular SystemBiomet, Inc.2004—
+1K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K042841, 1986–2012Source: 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), the FDA summary (predicates and indications), 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? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K993438Metal on Metal Acetabular System
Summary page 1
…th a cemented acetabular component prosthesis (21 CFR 888.3320) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet devices: K993438 - Metal on Metal Acetabular System K003363 - M2a T M 32mm Taper System K861114 - Mallory/Head PF Acetabul…
Biomet, Inc.2000—
*K003363M2A 32MM Taper System
Summary page 1
…1 CFR 888.3320) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet devices: K993438 - Metal on Metal Acetabular System K003363 - M2a T M 32mm Taper System K861114 - Mallory/Head PF Acetabular Component Device Description: The M2 aTM/C 2aTM Ace…
Biomet, Inc.2000—
*K861114Mallory/Head - PF Acetabular Component
Summary page 1
…ch Substantial Equivalence Is Claimed: Biomet devices: K993438 - Metal on Metal Acetabular System K003363 - M2a T M 32mm Taper System K861114 - Mallory/Head PF Acetabular Component Device Description: The M2 aTM/C 2aTM Acetabular System consists of a titanium outer acet…
Biomet, Inc.1986—

Also cleared against K993438: 6 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K113271 (Biomet Manufacturing, Inc., 2012) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K993438.

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—

What is it indicated for?

The M2 aTM/C 2 aTM Acetabular System is intended for cemented or non-cemented use in cases of:

1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular

necrosis

2) Rheumatoid arthritis

3) Correction of functional deformity

4) Revision procedures where other treatment or devices have been unsuccessful

5) Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal

femur with head involvement, unmanageable using other techniques

Indications for use as stated in the FDA summary.

Also cleared against K993438

6 other devices cite the same predicate.

  • K131647Trinity Acetabular SystemCorin USA · 2013
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
  • K103431Coren Total Hip SystemCorentec Co., Ltd. · 2011
  • K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 20081 recall
  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 20042 recalls

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/K042841 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042841: M2A/C2A Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042841

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026