510(k) Report

510(k) · Cleared

Cleared

M2A Acetabular System

K011110510(k) TraditionalCleared Jul 2, 200182-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 Jul 2, 2001 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 228 later devices descend from it.

Decided
Jul 2, 2001
Review
82 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

228 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2012: 14 descendants cleared2004: 1 descendant cleared2008: 2 descendants cleared2005: 1 descendant cleared2011: 6 descendants cleared2006: 4 descendants cleared2013: 10 descendants cleared2007: 2 descendants cleared2019: 25 descendants cleared2014: 14 descendants cleared2016: 12 descendants cleared2010: 1 descendant cleared2015: 13 descendants cleared2009: 1 descendant cleared2017: 13 descendants cleared2025: 15 descendants cleared2026: 20 descendants cleared2020: 18 descendants cleared2023: 9 descendants cleared2024: 17 descendants cleared2018: 12 descendants cleared2022: 8 descendants cleared2021: 10 descendants cleared200020052010201520202025
  1. This deviceK011110 M2A Acetabular SystemBiomet, Inc. · 2001
  2. Descendant · cites it directly · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  3. Descendant · cites it directly · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
  4. Descendant · 2 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  5. Descendant · 3 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  6. Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled

Showing 5 of 228 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 42007: 22008: 22009: 12010: 12011: 62012: 142013: 102014: 142015: 132016: 122017: 132018: 122019: 252020: 182021: 102022: 82023: 92024: 172025: 152026: 20
2004high 25 (2019) · low 1 (2004)2026

Most influential descendants

Showing 5 of 228 · See all
  • K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · cites it directly160descendants
  • K042037M2A Magnum SystemBiomet, Inc. · 2004 · cites it directly116descendants
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 2 generations on74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 3 generations on73descendants
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011110M2A Acetabular SystemBiomet, Inc.2001—
+1K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
+1K042037M2A Magnum SystemBiomet, Inc.2004—
+2K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+3K071723Zimmer Porolock Mis StemZimmer GmbH20082
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp20123

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200640
200720
200820
200910
201010
201160
2012140
2013100
2014140
2015130
2016120
2017130
2018120
2019250
2020180
2021100
202280
202390
2024170
2025150
2026200
FIG. 1 — Lineage of K011110, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (228)

See all 228

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

NumberDeviceApplicantDecidedDescendants
K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160
K042037M2A Magnum SystemBiomet, Inc.2004116
K110555Arcomxl Active ArticulationBiomet Manufacturing Corp201122
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?

  • Of its descendants, K043537 (Biomet, Inc., 2005) has gone furthest, with 160 descendants of its own.

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—

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/K011110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011110: M2A Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011110

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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