510(k) Report

510(k) · Cleared

Cleared

Intrinsic Stem

K923911510(k) TraditionalCleared Apr 14, 1993253-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

Turnkey Intergration USA, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Apr 14, 1993 after a 253-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 14, 1993
Review
253 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2002: 2 descendants cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK923911 Intrinsic StemTurnkey Intergration USA, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK021109 Esop CO-CR Femoral HeadsFournitures Hospitalieres · 2002
  3. Descendant · cites it directly · 1 of its ownK964878 Esop S/C Femoral StemFournitures Hospitalieres · 1998
  4. Descendant · 2 generations on · 0 of its ownK050556 Alumina HeadFournitures Hospitalieres Industrie · 2005
  5. Descendant · 2 generations on · 0 of its ownK021108 Esop HA Femoral StemFournitures Hospitalieres · 2002

Most influential descendants

Showing 4 of 4 · See all
  • K021109Esop CO-CR Femoral HeadsFournitures Hospitalieres · 2002 · cites it directly1descendant
  • K964878Esop S/C Femoral StemFournitures Hospitalieres · 1998 · cites it directly1descendant
  • K050556Alumina HeadFournitures Hospitalieres Industrie · 2005 · 2 generations on0descendants
  • K021108Esop HA Femoral StemFournitures Hospitalieres · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923911Intrinsic StemTurnkey Intergration USA, Inc.1993—
+1K021109Esop CO-CR Femoral HeadsFournitures Hospitalieres2002—
+1K964878Esop S/C Femoral StemFournitures Hospitalieres1998—
+2K050556Alumina HeadFournitures Hospitalieres Industrie2005—
+2K021108Esop HA Femoral StemFournitures Hospitalieres2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200220
200510
FIG. 1 — Lineage of K923911, 1993–2005Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K021109Esop CO-CR Femoral HeadsFournitures Hospitalieres20021
K964878Esop S/C Femoral StemFournitures Hospitalieres19981

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, K021109 (Fournitures Hospitalieres, 2002) has gone furthest, with 1 descendant 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 Turnkey Intergration USA, Inc.

26 FDA decisions under this applicant name. See the company

  • K991405Omni-Fix, Humeral NailTurnkey Intergration USA, Inc. · 1999
  • K990523B2C, Espace Revision Cup SystemTurnkey Intergration USA, Inc. · 1999
  • K990307Omni-Fix, Nail SystemTurnkey Intergration USA, Inc. · 1999
  • K972411Link Cement PlugTurnkey Intergration USA, Inc. · 1997
  • K970284Artos, Diplos SystemTurnkey Intergration USA, Inc. · 1997

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/K923911 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923911: Intrinsic Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923911

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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