510(k) Report

510(k) · Cleared

Cleared

F-24 Femoral Hip Prosthesis

K901687510(k) TraditionalCleared Sep 7, 1990148-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

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

Cleared on Sep 7, 1990 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 386 devices in its family, counting itself, has a Class I recall. 385 later devices descend from it.

Decided
Sep 7, 1990
Review
148 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

385 later devices descend from it, 2 citing it directly. 1 of the 386 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1996: 1 descendant cleared1997: 1 descendant cleared1999: 2 descendants cleared2003: 3 descendants cleared2005: 2 descendants cleared2017: 23 descendants cleared2016: 16 descendants cleared1998: 1 descendant cleared2011: 17 descendants cleared2012: 29 descendants cleared2008: 11 descendants cleared2006: 7 descendants cleared2004: 4 descendants cleared2010: 9 descendants cleared2020: 25 descendants cleared2007: 3 descendants cleared, 1 with a Class I recall12018: 22 descendants cleared2026: 23 descendants cleared2023: 20 descendants cleared2022: 20 descendants cleared2024: 19 descendants cleared2021: 20 descendants cleared2000: 1 descendant cleared2015: 13 descendants cleared2019: 24 descendants cleared2013: 26 descendants cleared2009: 5 descendants cleared2025: 25 descendants cleared2014: 13 descendants cleared1990200020102020
  1. This deviceK901687 F-24 Femoral Hip ProsthesisMed-Tek Corp. · 1990
  2. Descendant · cites it directly · 384 of its ownK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. Descendant · cites it directly · 363 of its ownK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
  4. Descendant · 2 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
  5. Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. Descendant · 4 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled

Showing 5 of 385 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 11999: 22000: 12003: 32004: 42005: 22006: 72007: 32008: 112009: 52010: 92011: 172012: 292013: 262014: 132015: 132016: 162017: 232018: 222019: 242020: 252021: 202022: 202023: 202024: 192025: 252026: 23
1996high 29 (2012) · low 0 (2001)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 385 · See all
  • K961378Delta Hip ProsthesisZimmer, Inc. · 1996 · cites it directly384descendants
  • K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997 · cites it directly363descendants
  • K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 2 generations on296descendants
  • K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 4 generations on198descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901687F-24 Femoral Hip ProsthesisMed-Tek Corp.1990—
+1K961378Delta Hip ProsthesisZimmer, Inc.19964
+1K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc.1997—
+2K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc.20032
+3K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
+4K042344Excia Total Hip SystemAesculap, Inc.200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
199920
200010
200330
200440
200520
200670
200731
2008110
200950
201090
2011170
2012290
2013260
2014130
2015130
2016160
2017230
2018220
2019240
2020250
2021200
2022200
2023200
2024190
2025250
2026230
FIG. 1 — Lineage of K901687, 1990–2026Source: 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.

1 device in this family has a Class I recall. 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? (385)

See all 385

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

NumberDeviceApplicantDecidedDescendants
K961378Delta Hip ProsthesisZimmer, Inc.1996384
K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc.1997363

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K961378 (Zimmer, Inc., 1996) has gone furthest, with 384 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—
Cite this page

510(k) Report. “K901687: F-24 Femoral Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K901687

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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