510(k) Report

510(k) · Cleared

Cleared

Inter-OP Metasul Hooded and Protrusio Acetabular Inserts

K001536510(k) TraditionalCleared Jul 27, 200071-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 Jul 27, 2000 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 77 later devices descend from it.

Decided
Jul 27, 2000
Review
71 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

77 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 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 cleared200020052010201520202025
  1. This deviceK001536 Inter-OP Metasul Hooded and Protrusio Acetabular InsertsSulzer Orthopedics, 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 77 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12008: 12009: 12011: 12012: 32013: 42014: 52015: 42016: 42017: 52018: 62019: 92020: 62021: 32022: 22023: 42024: 52025: 52026: 7
2004high 9 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 77 · 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)K001536Inter-OP Metasul Hooded and Protrusio Acetabular InsertsSulzer Orthopedics, 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
200410
200610
200810
200910
201110
201230
201340
201450
201540
201640
201750
201860
201990
202060
202130
202220
202340
202450
202550
202670
FIG. 1 — Lineage of K001536, 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 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
Get a 510(k) Report

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? (77)

See all 77

1 later device cites 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

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 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/K001536 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001536: Inter-OP Metasul Hooded and Protrusio Acetabular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001536

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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