510(k) Report

510(k) · Cleared

Cleared

Mod. Trochanter Screw & Washer W/ Anodized Titan.

K910664510(k) TraditionalCleared Apr 1, 1992412-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

Medimix Products, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Apr 1, 1992 after a 412-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 211 later devices descend from it.

Decided
Apr 1, 1992
Review
412 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

211 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2024: 17 descendants cleared1996: 1 descendant cleared2025: 18 descendants cleared1998: 1 descendant cleared2007: 1 descendant cleared2017: 13 descendants cleared2004: 4 descendants cleared2006: 1 descendant cleared2000: 2 descendants cleared2005: 3 descendants cleared2013: 12 descendants cleared2008: 3 descendants cleared2019: 14 descendants cleared2020: 15 descendants cleared2022: 16 descendants cleared2026: 14 descendants cleared2021: 9 descendants cleared2001: 1 descendant cleared2018: 12 descendants cleared2012: 8 descendants cleared2010: 3 descendants cleared2023: 20 descendants cleared2015: 6 descendants cleared2011: 5 descendants cleared2016: 9 descendants cleared2014: 3 descendants cleared1990200020102020
  1. This deviceK910664 Mod. Trochanter Screw & Washer W/ Anodized Titan.Medimix Products, Inc. · 1992
  2. Descendant · cites it directly · 210 of its ownK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
  3. Descendant · 2 generations on · 189 of its ownK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
  4. Descendant · 3 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 4 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
  6. Descendant · 5 generations on · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled

Showing 5 of 211 descendants. See all descendants

Descendants cleared per year

1996: 11998: 12000: 22001: 12004: 42005: 32006: 12007: 12008: 32010: 32011: 52012: 82013: 122014: 32015: 62016: 92017: 132018: 122019: 142020: 152021: 92022: 162023: 202024: 172025: 182026: 14
1996high 20 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 211 · See all
  • K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996 · cites it directly210descendants
  • K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998 · 2 generations on189descendants
  • K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · 3 generations on188descendants
  • K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 4 generations on168descendants
  • K082525Corin Metafix Femoral StemCorin USA · 2010 · 5 generations on71descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910664Mod. Trochanter Screw & Washer W/ Anodized Titan.Medimix Products, Inc.1992—
+1K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996—
+2K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998—
+3K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000—
+4K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051
+5K082525Corin Metafix Femoral StemCorin USA20102

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200020
200110
200440
200530
200610
200710
200830
201030
201150
201280
2013120
201430
201560
201690
2017130
2018120
2019140
2020150
202190
2022160
2023200
2024170
2025180
2026140
FIG. 1 — Lineage of K910664, 1992–2026Source: 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? (211)

See all 211

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

NumberDeviceApplicantDecidedDescendants
K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996210
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245

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, K961939 (Johnson & Johnson Professionals, Inc., 1996) has gone furthest, with 210 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 Medimix Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K914733TTL Medicated DressingMedimix Products, Inc. · 1992
  • K902772Pleasure PlusMedimix Products, Inc. · 1991
  • K860113Double-Ject Transfer NeedleMedimix Products, Inc. · 1986

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/K910664 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910664: Mod. Trochanter Screw & Washer W/ Anodized Titan..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910664

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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