510(k) Report

510(k) · Cleared

Cleared

M2A 32MM Taper System

K003363510(k) SpecialCleared Dec 15, 200049-day reviewClass II21 CFR 888.3390

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

Biomet, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Cleared on Dec 15, 2000 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 118 later devices descend from it.

Decided
Dec 15, 2000
Review
49 days
Class
Class II
Product code
KWY
Recalls
None
Predicates
0

118 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2011: 3 descendants cleared2008: 2 descendants cleared2013: 5 descendants cleared2006: 1 descendant cleared2009: 2 descendants cleared2012: 7 descendants cleared2015: 6 descendants cleared2016: 7 descendants cleared2021: 7 descendants cleared2017: 7 descendants cleared2019: 13 descendants cleared2023: 6 descendants cleared2022: 5 descendants cleared2018: 7 descendants cleared2020: 12 descendants cleared2026: 9 descendants cleared2024: 6 descendants cleared2014: 5 descendants cleared2025: 5 descendants cleared200020052010201520202025
  1. This deviceK003363 M2A 32MM Taper SystemBiomet, Inc. · 2000
  2. Descendant · cites it directly · 76 of its ownK033634 Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  4. Descendant · 3 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  5. Descendant · 4 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
  6. Descendant · 4 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

2004: 32006: 12008: 22009: 22011: 32012: 72013: 52014: 52015: 62016: 72017: 72018: 72019: 132020: 122021: 72022: 52023: 62024: 62025: 52026: 9
2004high 13 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 118 · See all
  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004 · cites it directly76descendants
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 2 generations on74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 3 generations on73descendants
  • K123392Avenir Muller StemZimmer GmbH · 2013 · 4 generations on41descendants
  • K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 4 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003363M2A 32MM Taper SystemBiomet, Inc.2000—
+1K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.20042
+2K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+3K071723Zimmer Porolock Mis StemZimmer GmbH20082
+4K123392Avenir Muller StemZimmer GmbH20134
+4K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
200610
200820
200920
201130
201270
201350
201450
201560
201670
201770
201870
2019130
2020120
202170
202250
202360
202460
202550
202690
FIG. 1 — Lineage of K003363, 2000–2026Source: 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 KWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWY device

  1. #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (118)

See all 118

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

NumberDeviceApplicantDecidedDescendants
K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.200476
K131647Trinity Acetabular SystemCorin USA201322
K103431Coren Total Hip SystemCorentec Co., Ltd.201111
K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110
K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.20082
K042841M2A/C2A Acetabular SystemBiomet, Inc.20041
K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.20040

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, K033634 (Centerpulse Orthopedics, Inc., 2004) has gone furthest, with 76 descendants of its own.

How does its category compare?

All KWY devices

KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWY

1in 2025

2008: 32009: 12010: 42011: 12012: 12013: 22014: 12015: 12016: 12017: 12018: 32019: 52020: 12022: 22023: 22025: 12026 (partial year): 1
2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWY

126in 2019

2008: 123 days median2010: 187 days median2018: 219 days median2019: 126 days median
2007high 219 (2018) · low 123 (2008)2026

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

Recalls per year · KWY

2in 2025

2007: 252009: 242010: 12012: 12013: 22016: 32017: 22018: 12019: 12024: 12025: 2
2007high 25 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWY

180in 2025

2007: 3702008: 9002009: 9612010: 6882011: 7582012: 9782013: 1,1482014: 1,0552015: 1,2132016: 8772017: 8262018: 1,3802019: 1,5302020: 1,2592021: 2762022: 2082023: 1782024: 2092025: 180
2007high 1,530 (2019) · low 178 (2023)2025

MAUDE reports naming product code KWY, 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
20070—25370
200831230900
20091—24961
201041871688
20111—0758
20121—1978
20132—21,148
20141—01,055
20151—01,213
20161—3877
20171—2826
2018321911,380
2019512611,530
20201—01,259
20210—0276
20222—0208
20232—0178
20240—1209
20251—2180
20261—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 KWY

The KWY category page

  • K253357b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
  • K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc. · 2025
  • K231526CORAIL Cemented Femoral StemDepuy Ireland UC · 2023
  • K223441SpaceFlex Acetabular CupG21, S.R.L. · 2023
  • K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG · 2022

https://510kreport.com/device/K003363 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003363: M2A 32MM Taper System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003363

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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