510(k) Report

510(k) · Cleared

Cleared

Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded

K033943510(k) TraditionalCleared Oct 18, 2004304-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

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

Cleared on Oct 18, 2004 as substantially equivalent to K003758 (Sulzer Orthopedics, Inc., 2001) and 2 other predicates after a 304-day review. Its family tree reaches back 1 generation to 2000.

Decided
Oct 18, 2004
Review
304 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K002379 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 1 other ancestorK002379 · M2A 28MM Ringloc Liner · Biomet, Inc. · 20002000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors K002379 · M2A 28MM Ringloc Liner · Biomet, Inc. · 20000
  1. Root · 1 generation backK002379 M2A 28MM Ringloc LinerBiomet, Inc. · 2000
  2. This deviceK033943 Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002379M2A 28MM Ringloc LinerBiomet, Inc.2000—
0 (this device)K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
FIG. 1 — Lineage of K033943, 2000–2004Source: 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? (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
*K003758Allofit Acetabular System
Summary page 1
…ent Class Ill devices. PREDICATE DEVICES: * Centerpulse Orthopedics Inc. Allofit Acetabular System, Alpha Metasul® Acetabular Insert, 28mm Standard and Hooded (K003758) • Biomet MWa~ Ringloc® Acetabular Liner (K002379) * Biomnet M2a -Taper"- Acetabular System (K(003363) DEVICE DESCRIPTION:…
Sulzer Orthopedics, Inc.2001—
*K002379M2A 28MM Ringloc Liner
Summary page 1
…terpulse Orthopedics Inc. Allofit Acetabular System, Alpha Metasul® Acetabular Insert, 28mm Standard and Hooded (K003758) • Biomet MWa~ Ringloc® Acetabular Liner (K002379) * Biomnet M2a -Taper"- Acetabular System (K(003363) DEVICE DESCRIPTION:…
Biomet, Inc.2000—
*K003363M2A 32MM Taper System
Summary page 1
…pha Metasul® Acetabular Insert, 28mm Standard and Hooded (K003758) • Biomet MWa~ Ringloc® Acetabular Liner (K002379) * Biomnet M2a -Taper"- Acetabular System (K(003363) DEVICE DESCRIPTION: shaped The Alp…
Biomet, Inc.2000—

Also cleared against K003758: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 3 other devices also cite its predicate K003758.

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 AlphaTM 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., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;

* 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 K003758

3 other devices cite the same predicate.

  • K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E…Zimmer, Inc. · 2019
  • K103352Versafitcup CC TrioMedacta International · 2011
  • K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc. · 2001

More from Centerpulse Orthopedics, Inc.

10 FDA decisions under this applicant name. See the company

  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 20042 recalls
  • 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/K033943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033943: Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033943

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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