510(k) Report

510(k) · Cleared

Cleared

Inter-OP Durasul Acetabular Inserts (4MM)

K002575510(k) TraditionalCleared Nov 15, 200089-day reviewClass II21 CFR 888.3360

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

Sulzer Orthopedics, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Nov 15, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 326 later devices descend from it.

Decided
Nov 15, 2000
Review
89 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

326 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2006: 6 descendants cleared2022: 23 descendants cleared2013: 22 descendants cleared2010: 9 descendants cleared2005: 1 descendant cleared2004: 2 descendants cleared2011: 20 descendants cleared2008: 7 descendants cleared2009: 6 descendants cleared2025: 24 descendants cleared2016: 14 descendants cleared2019: 19 descendants cleared2017: 18 descendants cleared2007: 1 descendant cleared2018: 18 descendants cleared2014: 10 descendants cleared2012: 22 descendants cleared2020: 18 descendants cleared2021: 20 descendants cleared2023: 19 descendants cleared2024: 16 descendants cleared2015: 10 descendants cleared2026: 19 descendants cleared200020052010201520202025
  1. This deviceK002575 Inter-OP Durasul Acetabular Inserts (4MM)Sulzer Orthopedics, Inc. · 2000
  2. Descendant · cites it directly · 285 of its ownK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  3. Descendant · 2 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  4. Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  5. Descendant · 3 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
  6. Descendant · cites it directly · 162 of its ownK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled

Showing 5 of 326 descendants. See all descendants

Descendants cleared per year

2002: 22004: 22005: 12006: 62007: 12008: 72009: 62010: 92011: 202012: 222013: 222014: 102015: 102016: 142017: 182018: 182019: 192020: 182021: 202022: 232023: 192024: 162025: 242026: 19
2002high 24 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 326 · See all
  • K022902Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002 · cites it directly285descendants
  • K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 2 generations on267descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
  • K043079Bicontact Hip System with U-CapAesculap · 2004 · 3 generations on166descendants
  • K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · cites it directly162descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002575Inter-OP Durasul Acetabular Inserts (4MM)Sulzer Orthopedics, Inc.2000—
+1K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
+2K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
+2K042344Excia Total Hip SystemAesculap, Inc.200510
+3K043079Bicontact Hip System with U-CapAesculap2004—
+1K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc.20021

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200420
200510
200660
200710
200870
200960
201090
2011200
2012220
2013220
2014100
2015100
2016140
2017180
2018180
2019190
2020180
2021200
2022230
2023190
2024160
2025240
2026190
FIG. 1 — Lineage of K002575, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LWJ? 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? (326)

See all 326

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

NumberDeviceApplicantDecidedDescendants
K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002285
K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc.2002162
K062419Trident Large Diameter Acetabular InsertsHowmedica Osteonics Corp.200623

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, K022902 (Smith & Nephew, Inc., 2002) has gone furthest, with 285 descendants of its own.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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
20072—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
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 LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007

https://510kreport.com/device/K002575 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002575: Inter-OP Durasul Acetabular Inserts (4MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002575

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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