510(k) Report

510(k) · Cleared

Cleared

P.F.C. Sigma Porous Modular Keel Tibial Tray

K991106510(k) TraditionalCleared Jun 9, 199969-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 Jun 9, 1999 as substantially equivalent to K892394 (Johnson & Johnson Professionals, Inc., 1989) and 4 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.

Decided
Jun 9, 1999
Review
69 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K864671 (1987). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1992: 1 other ancestor1989: 1 other ancestor2001: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant clearedK864671 · Anatomic Modular Knee (Amk) System · Depuy, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K864671 · Anatomic Modular Knee (Amk) System · Depuy, Inc. · 19870
  1. Root · 1 generation backK864671 Anatomic Modular Knee (Amk) SystemDepuy, Inc. · 1987
  2. This deviceK991106 P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999
  3. Descendant · cites it directly · 1 of its ownK182301 PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
  4. Descendant · 2 generations on · 0 of its ownK200765 Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021
  5. Descendant · cites it directly · 0 of its ownK003026 PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc. · 2001

Most influential descendants

Showing 3 of 3 · See all
  • K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019 · cites it directly1descendant
  • K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021 · 2 generations on0descendants
  • K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864671Anatomic Modular Knee (Amk) SystemDepuy, Inc.1987—
0 (this device)K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc.1999—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.2019—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.2021—
+1K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201910
202110
FIG. 1 — Lineage of K991106, 1987–2021Source: 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
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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
*K892394P.F.C. Modular Knee System, Tibial Tray-Porous
Summary page 2
…Keel Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the P.F.C. Modular Tibial Tray —Porous (K892394 and K961685), P.F.C. Modular Plus Tibial Tray (K923807 and K961685), AMK Total Knee (K864671) and CRX Tibial Tray (K961379). The…
Johnson & Johnson Professionals, Inc.1989—
*K961685P.F.C. Cruciate Retaining Knee System (Size 1.5)
Summary page 2
…Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the P.F.C. Modular Tibial Tray —Porous (K892394 and K961685), P.F.C. Modular Plus Tibial Tray (K923807 and K961685), AMK Total Knee (K864671) and CRX Tibial Tray (K961379). The determinati…
Johnson & Johnson Professionals, Inc.19967
*K923807P.F.C. Modular Total Knee System, Modular Plus
Summary page 2
…of intended use, materials, design, sterilization method, and packaging to the P.F.C. Modular Tibial Tray —Porous (K892394 and K961685), P.F.C. Modular Plus Tibial Tray (K923807 and K961685), AMK Total Knee (K864671) and CRX Tibial Tray (K961379). The determination of substantial equivalence for this devi…
Johnson & Johnson International19921
*K864671Anatomic Modular Knee (Amk) System
Summary page 2
…erilization method, and packaging to the P.F.C. Modular Tibial Tray —Porous (K892394 and K961685), P.F.C. Modular Plus Tibial Tray (K923807 and K961685), AMK Total Knee (K864671) and CRX Tibial Tray (K961379). The determination of substantial equivalence for this device was based on a detailed device desc…
Depuy, Inc.1987—
*K961379Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501)
Summary page 2
…ing to the P.F.C. Modular Tibial Tray —Porous (K892394 and K961685), P.F.C. Modular Plus Tibial Tray (K923807 and K961685), AMK Total Knee (K864671) and CRX Tibial Tray (K961379). The determination of substantial equivalence for this device was based on a detailed device description, performance testing a…
Depuy, Inc.1996—

Also cleared against K892394: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191
K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc.20010

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?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K182301 (DePuy Orthopaedics, Inc., 2019) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K892394.

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 P.F.C. Sigma Porous Modular Keel Tibial Tray is indicated for use in total knee replacements for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

In accordance with Federal (USA) requirements, the P.F.C. Sigma Knee Modular Keel Tibial Tray is indicated for use only with PMMA bone cement.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K892394

2 other devices cite the same predicate.

  • K102367Optigen Total Knee SystemU&I Corp. · 2010
  • K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999

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/K991106 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991106: P.F.C. Sigma Porous Modular Keel Tibial Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991106

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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