510(k) Report

510(k) · Cleared

Cleared

Depuy Sigma XLK Tibial Inserts

K040166510(k) TraditionalCleared Feb 23, 200428-day reviewClass II21 CFR 888.3560

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

DePuy Orthopaedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 23, 2004 as substantially equivalent to K033272 (DePuy Orthopaedics, Inc., 2004) and 4 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1994. 324 later devices descend from it.

Decided
Feb 23, 2004
Review
28 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K943462 (1994). 5 ancestors in all. 324 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2011: 6 descendants cleared2006: 2 descendants cleared2024: 37 descendants cleared2010: 3 descendants cleared2005: 1 descendant cleared2021: 29 descendants cleared2009: 4 descendants cleared2013: 7 descendants cleared2020: 28 descendants cleared2008: 1 descendant cleared2007: 2 descendants cleared2012: 2 descendants cleared2015: 13 descendants cleared2019: 27 descendants cleared2017: 12 descendants cleared2026: 33 descendants cleared2016: 16 descendants cleared2014: 6 descendants cleared2022: 25 descendants cleared2018: 12 descendants cleared2023: 29 descendants cleared2025: 29 descendants clearedK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalledK033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 29 descendants3 generations forward: 40 descendants4 generations forward: 57 descendants5 generations forward: 69 descendants6 generations forward: 52 descendants7 generations forward: 33 descendants8 generations forward: 13 descendants9 generations forward: 18 descendants10 generations forward: 6 descendants11 generations forward: 2 descendants K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled0+5+10
  1. Root · 2 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 1 generation backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. This deviceK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. Descendant · cites it directly · 158 of its ownK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
  5. Descendant · cites it directly · 114 of its ownK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
  6. Descendant · 2 generations on · 75 of its ownK092122 Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc. · 2009
  7. Descendant · cites it directly · 61 of its ownK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
  8. Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled

Showing 5 of 324 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 22008: 12009: 42010: 32011: 62012: 22013: 72014: 62015: 132016: 162017: 122018: 122019: 272020: 282021: 292022: 252023: 292024: 372025: 292026: 33
2005high 37 (2024) · low 1 (2005)2026

Most influential descendants

Showing 5 of 324 · See all
  • K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005 · cites it directly158descendants
  • K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010 · cites it directly114descendants
  • K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc. · 2009 · 2 generations on75descendants
  • K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · cites it directly61descendants
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−1K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
0 (this device)K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
+1K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005—
+1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010—
+2K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc.2009—
+1K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.20061
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200720
200810
200940
201030
201160
201220
201370
201460
2015130
2016160
2017120
2018120
2019270
2020280
2021290
2022250
2023290
2024370
2025290
2026330
FIG. 1 — Lineage of K040166, 1994–2026Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K033272Depuy Sigma Tibial Inserts
Cleared while this submission was under review
Summary page 1
…cemented prosthesis; Class II DEVICE PRODUCT COI)E: 87 JWIH SUBSTANTIALLY EQUIVALENT DEVICE: DePuy Sigma Tibial Inserts - K033272 Johnson & Johnson (now DePuy') Darwin Knee System - K943462, K95…
DePuy Orthopaedics, Inc.200451
*K943462Darwin Knee System
Summary page 1
…DePuy Sigma Tibial Inserts - K033272 Johnson & Johnson (now DePuy') Darwin Knee System - K943462, K950010, K961685, K971189 DEVICE DESCRIPTION: The DePuy Sigma XLK Tibial Inserts are po…
Johnson & Johnson Professionals, Inc.19948
*K950010Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated
Summary page 1
…DePuy Sigma Tibial Inserts - K033272 Johnson & Johnson (now DePuy') Darwin Knee System - K943462, K950010, K961685, K971189 DEVICE DESCRIPTION: The DePuy Sigma XLK Tibial Inserts are posterior l…
Johnson & Johnson Professionals, Inc.199516
*K961685P.F.C. Cruciate Retaining Knee System (Size 1.5)
Summary page 1
…Puy Sigma Tibial Inserts - K033272 Johnson & Johnson (now DePuy') Darwin Knee System - K943462, K950010, K961685, K971189 DEVICE DESCRIPTION: The DePuy Sigma XLK Tibial Inserts are posterior lipped, cr…
Johnson & Johnson Professionals, Inc.19967
*K971189P.F.C. Sigma Knee System (Size 1.5)
Summary page 1
…Johnson & Johnson (now DePuy') Darwin Knee System - K943462, K950010, K961685, K971189 DEVICE DESCRIPTION: The DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilizcd tibial inserts wit…
Johnson & Johnson Professionals, Inc.1997—

Also cleared against K033272: 3 other devices →

What descends from it? (324)

See all 324

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

NumberDeviceApplicantDecidedDescendants
K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005158
K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114
K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.200661
K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.201139
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240

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?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
  • 4 of the 5 ancestors have a recall of any class.
  • Of its descendants, K052472 (DePuy Orthopaedics, Inc., 2005) has gone furthest, with 158 descendants of its own.
  • 3 other devices also cite its predicate K033272.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

The Sigma XLK Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

Indications for use as stated in the FDA summary.

Also cleared against K033272

3 other devices cite the same predicate.

  • K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral…Depuy Ireland UC · 2024
  • K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc. · 20111 recall
  • K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 20091 recall

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K040166 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040166: Depuy Sigma XLK Tibial Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040166

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026