510(k) Report

510(k) · Cleared

Cleared

Depuy PFC Sigma Knee Prosthesis

K060515510(k) SpecialCleared Mar 23, 200624-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 Mar 23, 2006 as substantially equivalent to K040281 (DePuy Orthopaedics, Inc., 2004) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1987. 36 later devices descend from it.

Decided
Mar 23, 2006
Review
24 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K870730 (1987). 11 ancestors in all. 36 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1994: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor2013: 2 descendants cleared2012: 2 descendants cleared2024: 3 descendants cleared2020: 4 descendants cleared2019: 3 descendants cleared2021: 7 descendants cleared2022: 3 descendants cleared2023: 6 descendants cleared2018: 3 descendants cleared2025: 3 descendants clearedK870730 · Noiles Total Knee Prosthesis · Joint Medical Products Corp. · 1987K003182 · Orthogenesis LPS System · Depuy, Inc. · 2001K040281 · LPS Metaphyseal Sleeve (Limb Preservation System) · DePuy Orthopaedics, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 7 other ancestors 1 generation forward: 5 descendants2 generations forward: 15 descendants3 generations forward: 7 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants K040281 · LPS Metaphyseal Sleeve (Limb Preservation System) · DePuy Orthopaedics, Inc. · 2004K003182 · Orthogenesis LPS System · Depuy, Inc. · 2001K870730 · Noiles Total Knee Prosthesis · Joint Medical Products Corp. · 19870+5
  1. Root · 3 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
  2. 2 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
  3. 1 generation backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
  4. This deviceK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
  5. Descendant · cites it directly · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
  6. Descendant · cites it directly · 14 of its ownK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
  7. Descendant · 2 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
  8. Descendant · 2 generations on · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
  9. Descendant · 2 generations on · 10 of its ownK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2012: 22013: 22018: 32019: 32020: 42021: 72022: 32023: 62024: 32025: 3
2012high 7 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 36 · See all
  • K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · cites it directly14descendants
  • K110404Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · cites it directly14descendants
  • K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · 2 generations on12descendants
  • K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · 2 generations on10descendants
  • K121037Lospa Tibial Base PlateCorentec Co., Ltd. · 2012 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K870730Noiles Total Knee ProsthesisJoint Medical Products Corp.1987—
−2K003182Orthogenesis LPS SystemDepuy, Inc.2001—
−1K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc.2004—
0 (this device)K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.2006—
+1K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.2020—
+1K110404Eaum Total Knee SystemCorentec Co., Ltd.20122
+2K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal…Conformis, Inc.2020—
+2K210191Identity Imprint Knee Replacement SystemConformis, Inc.20211
+2K121037Lospa Tibial Base PlateCorentec Co., Ltd.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199310
199410
199610
199720
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201320
201830
201930
202040
202170
202230
202360
202430
202530
FIG. 1 — Lineage of K060515, 1987–2025Source: 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? (2)

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
*K040281LPS Metaphyseal Sleeve (Limb Preservation System)
Summary page 1
…Class II Device DEVICE PRODUCT CODE: JWH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy LPS Metaphyseal Sleeve Component (K040281, cleared July 9, 2004) Darwin Knee System (TC3) (K952830, cleared J…
DePuy Orthopaedics, Inc.2004—
*K952830Darwin Knee System (TC3)
Summary page 1
…l Sleeve Component (K040281, cleared July 9, 2004) Darwin Knee System (TC3) (K952830, cleared January 18, 1996) DEVICE DESCRIPTION: The DePuy Sigma Femoral Adapters are a modification to the previously cle…
Johnson & Johnson Professionals, Inc.19968

Also cleared against K040281: 3 other devices →

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014
K110404Eaum Total Knee SystemCorentec Co., Ltd.201214
K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132
K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191
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 19 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K201023 (Conformis, Inc., 2020) has gone furthest, with 14 descendants of its own.
  • 3 other devices also cite its predicate K040281.

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 PFC® Sigma Total Knee Prosthesis is 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. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K040281

3 other devices cite the same predicate.

  • K202248Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC · 2020
  • K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 20074 Class I recalls
  • K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. · 20071 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/K060515 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060515: Depuy PFC Sigma Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060515

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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