510(k) Report

510(k) · Cleared

Cleared

M2A Magnum System

K042037510(k) TraditionalCleared Oct 1, 200464-day reviewClass III21 CFR 888.3330

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

Biomet, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Oct 1, 2004 as substantially equivalent to K011110 (Biomet, Inc., 2001) and 4 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1988. 116 later devices descend from it.

Decided
Oct 1, 2004
Review
64 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K881288 (1988). 14 ancestors in all, the oldest K845025 (1985). 116 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1985: 1 other ancestor1991: 1 other ancestor2012: 4 descendants cleared2006: 4 descendants cleared2008: 2 descendants cleared2013: 5 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2015: 6 descendants cleared2016: 7 descendants cleared2021: 8 descendants cleared2017: 6 descendants cleared2018: 8 descendants cleared2019: 14 descendants cleared2020: 12 descendants cleared2025: 7 descendants cleared2026: 9 descendants cleared2024: 8 descendants cleared2014: 5 descendants cleared2022: 3 descendants cleared2023: 5 descendants clearedK881288 · Corin Modular Moore Stem · Orthopedic Systems, Inc. · 1988K960538 · Opteon Unipolar · Exactech, Inc. · 1996K984028 · The New Bio-Moore Endo Heads · Biomet, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 8 descendants3 generations forward: 25 descendants4 generations forward: 29 descendants5 generations forward: 26 descendants6 generations forward: 13 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants K984028 · The New Bio-Moore Endo Heads · Biomet, Inc. · 1999K960538 · Opteon Unipolar · Exactech, Inc. · 1996K881288 · Corin Modular Moore Stem · Orthopedic Systems, Inc. · 19880+5
  1. Root · 3 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
  2. 2 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
  3. 1 generation backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  4. This deviceK042037 M2A Magnum SystemBiomet, Inc. · 2004
  5. Descendant · cites it directly · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  6. Descendant · 2 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  7. Descendant · 3 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
  8. Descendant · 3 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  9. Descendant · cites it directly · 26 of its ownK062995 M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp · 2006

Showing 5 of 116 descendants. See all descendants

Descendants cleared per year

2006: 42008: 22009: 12011: 22012: 42013: 52014: 52015: 62016: 72017: 62018: 82019: 142020: 122021: 82022: 32023: 52024: 82025: 72026: 9
2006high 14 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 116 · See all
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · cites it directly74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 2 generations on73descendants
  • K123392Avenir Muller StemZimmer GmbH · 2013 · 3 generations on41descendants
  • K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 3 generations on34descendants
  • K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp · 2006 · cites it directly26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881288Corin Modular Moore StemOrthopedic Systems, Inc.1988—
−2K960538Opteon UnipolarExactech, Inc.1996—
−1K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
0 (this device)K042037M2A Magnum SystemBiomet, Inc.2004—
+1K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+2K071723Zimmer Porolock Mis StemZimmer GmbH20082
+3K123392Avenir Muller StemZimmer GmbH20134
+3K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
+1K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199110
199510
199610
199710
199810
200010
200120
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200640
200820
200910
201120
201240
201350
201450
201560
201670
201760
201880
2019140
2020120
202180
202230
202350
202480
202570
202690
FIG. 1 — Lineage of K042037, 1988–2026Source: 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 KWA? 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? (5)

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
*K011110M2A Acetabular System
Summary page 1
…esis (888.3330) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The MEaTM Magnum TM System is substantially equivalent to: K01 1110 M2a TM Acetabular System 38mm (Biomet) K984028 Bio-Moore Endo Heads (Biomet) K002106 New Bio-Moor…
Biomet, Inc.2001—
*K984028The New Bio-Moore Endo Heads
Summary page 1
…quivalence Is Claimed: The MEaTM Magnum TM System is substantially equivalent to: K01 1110 M2a TM Acetabular System 38mm (Biomet) K984028 Bio-Moore Endo Heads (Biomet) K002106 New Bio-Moore Endo Head, Taper Adapter JBiomet) K031963 Con…
Biomet, Inc.1999—
*K002106New Bio-Moore Endo Head, Taper Adapter
Summary page 1
…tem is substantially equivalent to: K01 1110 M2a TM Acetabular System 38mm (Biomet) K984028 Bio-Moore Endo Heads (Biomet) K002106 New Bio-Moore Endo Head, Taper Adapter JBiomet) K031963 Conserve® Plus Spiked Shell and Conserve Total 56mm Femor…
Biomet, Inc.2000—
*K031963Conserve Plus Spiked Acetabular Shells and Conserve Total 56MM Femoral Head
Summary page 1
…abular System 38mm (Biomet) K984028 Bio-Moore Endo Heads (Biomet) K002106 New Bio-Moore Endo Head, Taper Adapter JBiomet) K031963 Conserve® Plus Spiked Shell and Conserve Total 56mm Femoral Head (Wright Medical) K021249 Metal T…
Wrightmedicaltechnologyinc2003—
*K021349Metal Transcend Articulation System (Larger Sizes)
Our reading of the summary gave K021249, FDA’s number for Surgassist Flexshaft 2, Model FS2 14 (Power Medical Interventions, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Metal Transcend Articulation System”.
Wrightmedicaltechnologyinc2002—

Also cleared against K011110: 5 other devices →

What descends from it? (116)

See all 116

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200674
K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp200626
K131647Trinity Acetabular SystemCorin USA201322
K110555Arcomxl Active ArticulationBiomet Manufacturing Corp201122
K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063
K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.20082
K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120
K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp20060

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?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • None of the 14 ancestors has a recall.
  • Of its descendants, K053536 (Zimmer GmbH, 2006) has gone furthest, with 74 descendants of its own.
  • 5 other devices also cite its predicate K011110.

How does its category compare?

All KWA devices

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

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

What is it indicated for?

The M2aTM Magnum TM System is indicated for use in patients requiring total hip replacement due to the following:

* Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.

* Rheumatoid arthritis

* Correction of functional deformity

* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques

* Revision of previously failed total hip arthroplasty

Indications for use as stated in the FDA summary.

Also cleared against K011110

5 other devices cite the same predicate.

  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 20112 recalls
  • K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 20081 recall
  • K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp · 20062 recalls
  • K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005

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 KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K042037 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042037: M2A Magnum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042037

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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