510(k) Report

510(k) · Cleared

Cleared

Howmedica V40 22MM Femoral Head

K950541510(k) TraditionalCleared Mar 21, 199542-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

Howmedica Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Mar 21, 1995 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 299 later devices descend from it.

Decided
Mar 21, 1995
Review
42 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2016: 12 descendants cleared2011: 16 descendants cleared2005: 1 descendant cleared2004: 2 descendants cleared2017: 17 descendants cleared2006: 6 descendants cleared2007: 1 descendant cleared2008: 6 descendants cleared2010: 7 descendants cleared2018: 18 descendants cleared2013: 21 descendants cleared2009: 5 descendants cleared2019: 17 descendants cleared2015: 7 descendants cleared2020: 17 descendants cleared2022: 22 descendants cleared2021: 20 descendants cleared2023: 18 descendants cleared2012: 22 descendants cleared2014: 7 descendants cleared2026: 19 descendants cleared2024: 15 descendants cleared2025: 22 descendants cleared1995200020052010201520202025
  1. This deviceK950541 Howmedica V40 22MM Femoral HeadHowmedica Corp. · 1995
  2. Descendant · cites it directly · 298 of its ownK022077 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · Recalled
  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 · 4 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled

Showing 5 of 299 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22005: 12006: 62007: 12008: 62009: 52010: 72011: 162012: 222013: 212014: 72015: 72016: 122017: 172018: 182019: 172020: 172021: 202022: 222023: 182024: 152025: 222026: 19
2002high 22 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 299 · See all
  • K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · cites it directly298descendants
  • 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
  • K093472Trinity Acetabular SystemCorin USA · 2010 · 4 generations on117descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950541Howmedica V40 22MM Femoral HeadHowmedica Corp.1995—
+1K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp.200212
+2K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
+2K042344Excia Total Hip SystemAesculap, Inc.200510
+3K043079Bicontact Hip System with U-CapAesculap2004—
+4K093472Trinity Acetabular SystemCorin USA20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200510
200660
200710
200860
200950
201070
2011160
2012220
2013210
201470
201570
2016120
2017170
2018180
2019170
2020170
2021200
2022220
2023180
2024150
2025220
2026190
FIG. 1 — Lineage of K950541, 1995–2026Source: 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
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? (299)

See all 299

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp.2002298

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, K022077 (Howmedica Osteonics Corp., 2002) has gone furthest, with 298 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 Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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/K950541 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950541: Howmedica V40 22MM Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950541

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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