510(k) Report

510(k) · Cleared

Cleared

Allofit Acetabular System

K003758510(k) TraditionalCleared Mar 7, 200191-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

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

Cleared on Mar 7, 2001 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Mar 7, 2001
Review
91 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2011: 1 descendant cleared2019: 1 descendant cleared2001: 1 descendant cleared2025: 3 descendants cleared2012: 2 descendants cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK003758 Allofit Acetabular SystemSulzer Orthopedics, Inc. · 2001
  2. Descendant · cites it directly · 4 of its ownK190660 G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7…Zimmer, Inc. · 2019
  3. Descendant · cites it directly · 4 of its ownK103352 Versafitcup CC TrioMedacta International · 2011
  4. Descendant · 2 generations on · 2 of its ownK120531 Versafitcup CC Trio-Additional LinersMedacta International · 2012
  5. Descendant · 2 generations on · 1 of its ownK122911 Versafitcup CC Trio ExtensionMedacta International · 2012
  6. Descendant · 2 generations on · 0 of its ownK261453 G7® Acetabular SystemZimmer Biomet · 2026

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12011: 12012: 22019: 12025: 32026: 3
2001high 3 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 12 · See all
  • K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc. · 2019 · cites it directly4descendants
  • K103352Versafitcup CC TrioMedacta International · 2011 · cites it directly4descendants
  • K120531Versafitcup CC Trio-Additional LinersMedacta International · 2012 · 2 generations on2descendants
  • K122911Versafitcup CC Trio ExtensionMedacta International · 2012 · 2 generations on1descendant
  • K261453G7® Acetabular SystemZimmer Biomet · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003758Allofit Acetabular SystemSulzer Orthopedics, Inc.2001—
+1K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular…Zimmer, Inc.2019—
+1K103352Versafitcup CC TrioMedacta International2011—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International2012—
+2K122911Versafitcup CC Trio ExtensionMedacta International2012—
+2K261453G7® Acetabular SystemZimmer Biomet2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
201110
201220
201910
202530
202630
FIG. 1 — Lineage of K003758, 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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194
K103352Versafitcup CC TrioMedacta International20114
K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.20040
K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc.20010

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, K190660 (Zimmer, Inc., 2019) has gone furthest, with 4 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 Sulzer Orthopedics, Inc.

45 FDA decisions under this applicant name. See the company

  • K022985Ascendent Acetabular SystemSulzer Orthopedics, Inc. · 20021 recall
  • K021578Natural-Knee II System Cocr Tibial BaseplateSulzer Orthopedics, Inc. · 2002
  • K020713MS-30 Lateral Femoral StemSulzer Orthopedics, Inc. · 20021 recall
  • K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc. · 2001
  • K013031Most Options SystemSulzer Orthopedics, Inc. · 20013 recalls

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/K003758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003758: Allofit 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/K003758

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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