510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded

K033634510(k) TraditionalCleared Sep 15, 2004301-day reviewClass III21 CFR 888.3330Recalls 2

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

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

Cleared on Sep 15, 2004 as substantially equivalent to K974728 (Sulzer Orthopedics, Inc., 1999) and 5 other predicates after a 301-day review. Its family tree reaches back 2 generations to 1988. 76 later devices descend from it. It has been recalled 2 times.

Decided
Sep 15, 2004
Review
301 days
Class
Class III
Product code
KWA
Recalls
2
Predicates
6

Its longest line of descent runs back 2 generations to K883460 (1988). 8 ancestors in all. 76 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 4 other ancestors1999: 1 other ancestor1995: 1 other ancestor2006: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2018: 6 descendants cleared2013: 4 descendants cleared2019: 9 descendants cleared2020: 6 descendants cleared2015: 4 descendants cleared2017: 5 descendants cleared2012: 3 descendants cleared2014: 5 descendants cleared2026: 7 descendants cleared2016: 4 descendants cleared2025: 5 descendants cleared2023: 4 descendants cleared2022: 2 descendants cleared2024: 5 descendants cleared2021: 3 descendants clearedK883460 · Focus Total Hip System · Depuy, Inc. · 1988K980513 · Articul/Eze Femoral Heads · DePuy Orthopaedics, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 8 descendants4 generations forward: 21 descendants5 generations forward: 24 descendants6 generations forward: 13 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants K980513 · Articul/Eze Femoral Heads · DePuy Orthopaedics, Inc. · 1998K883460 · Focus Total Hip System · Depuy, Inc. · 19880+5
  1. Root · 2 generations backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
  2. 1 generation backK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
  3. This deviceK033634 Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004
  4. Descendant · cites it directly · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  5. Descendant · 2 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  6. Descendant · 3 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
  7. Descendant · 3 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  8. Descendant · 3 generations on · 19 of its ownK130899 Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 12011: 12012: 32013: 42014: 52015: 42016: 42017: 52018: 62019: 92020: 62021: 32022: 22023: 42024: 52025: 52026: 7
2006high 9 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 76 · 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
  • K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013 · 3 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K883460Focus Total Hip SystemDepuy, Inc.1988—
−1K980513Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc.1998—
0 (this device)K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, 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—
+3K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199910
200040

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200910
201110
201230
201340
201450
201540
201640
201750
201860
201990
202060
202130
202220
202340
202450
202550
202670
FIG. 1 — Lineage of K033634, 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? (6)

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
*K974728Inter-OP Metasul Acetabular System
Summary page 1
…s are Preamendment Class Ill devices. PREDICATE DEVICES: * Centerpulse Orthopedics Epsilon Metasul Acetabular Insert, 28mm Standard (K974728) and Hooded (K001526) *Centerpulse Metasulo Modular Femoral Head (K974728) *Biomet MWa' Ringloc® Acetabular Liner (K002379) *B…
Sulzer Orthopedics, Inc.19991
*K001536Inter-OP Metasul Hooded and Protrusio Acetabular Inserts
Our reading of the summary gave K001526, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Centerpulse Orthopedics Epsilon Metasul Acetabular Insert, 28mm Hooded”.
Sulzer Orthopedics, Inc.2000—
*K002379M2A 28MM Ringloc Liner
Summary page 1
…Metasul Acetabular Insert, 28mm Standard (K974728) and Hooded (K001526) *Centerpulse Metasulo Modular Femoral Head (K974728) *Biomet MWa' Ringloc® Acetabular Liner (K002379) *Biomet M2a -TaperTM Acetabular System (K003363, K(993438, unknown) *J&J DePuy Ultarnet Femoral Heads (K98051 3) DEVICE DESC…
Biomet, Inc.2000—
*K003363M2A 32MM Taper System
Summary page 1
…28) and Hooded (K001526) *Centerpulse Metasulo Modular Femoral Head (K974728) *Biomet MWa' Ringloc® Acetabular Liner (K002379) *Biomet M2a -TaperTM Acetabular System (K003363, K(993438, unknown) *J&J DePuy Ultarnet Femoral Heads (K98051 3) DEVICE DESCRIPTION: The Epsilon Metasul 32mm Acetabular Inser…
Biomet, Inc.2000—
*K993438Metal on Metal Acetabular System
Summary page 1
…ded (K001526) *Centerpulse Metasulo Modular Femoral Head (K974728) *Biomet MWa' Ringloc® Acetabular Liner (K002379) *Biomet M2a -TaperTM Acetabular System (K003363, K(993438, unknown) *J&J DePuy Ultarnet Femoral Heads (K98051 3) DEVICE DESCRIPTION: The Epsilon Metasul 32mm Acetabular Insert is a hem…
Biomet, Inc.2000—
*K980513Articul/Eze Femoral Heads
Summary page 1
…Head (K974728) *Biomet MWa' Ringloc® Acetabular Liner (K002379) *Biomet M2a -TaperTM Acetabular System (K003363, K(993438, unknown) *J&J DePuy Ultarnet Femoral Heads (K98051 3) DEVICE DESCRIPTION: The Epsilon Metasul 32mm Acetabular Insert is a hemnispherically shaped design, composed of an outer compo…
DePuy Orthopaedics, Inc.1998—

Also cleared against K974728: 1 other device →

What descends from it? (76)

See all 76

2 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
K091973Metasul Taper Liners, Metasul Femoral HeadsZimmer GmbH20090

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 17, 2014Class IIZ-1133-2015Package design/selectionPotential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic…
Jun 30, 2008Not classifiedZ-2299-2008Packaging process controlThe wrong part may be in the package. Package may contain a 28 mm head.

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 9.5 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K053536 (Zimmer GmbH, 2006) has gone furthest, with 74 descendants of its own.
  • 1 other device also cites its predicate K974728.

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 EpsilonTM Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following:

patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, post-traumatic arthritis or avascular necrosis and inflammatory joint disease (IJD), e.g., rheumatoid arthiritis;

those patients with failed previous surgery where pain, deformity, or dysfunction persists;

revision of previously failed hip arthroplasty.

Indications for use as stated in the FDA summary.

Also cleared against K974728

1 other device cites the same predicate.

  • K091973Metasul Taper Liners, Metasul Femoral HeadsZimmer GmbH · 20094 recalls

More from Centerpulse Orthopedics, Inc.

10 FDA decisions under this applicant name. See the company

  • K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004
  • K040947Durasul BipolarCenterpulse Orthopedics, Inc. · 2004
  • K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc. · 20041 recall
  • K033664Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc. · 20031 recall
  • K032348Converge Reti-Lock Multi-Hole Reinforcement CupCenterpulse Orthopedics, Inc. · 2003

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/K033634 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033634: Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033634

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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