510(k) Report

510(k) · Cleared

Cleared

P.F.C. Modular Plus Offset Tibial Tray

K984158510(k) TraditionalCleared Jan 28, 199970-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, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 28, 1999 as substantially equivalent to K884796 (Johnson & Johnson Professionals, Inc., 1989) and 3 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.

Decided
Jan 28, 1999
Review
70 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K884796 (1989). 4 ancestors in all. 7 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor2011: 1 descendant cleared2002: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant cleared2003: 1 descendant cleared2012: 1 descendant cleared2021: 1 descendant clearedK884796 · P.F.C.(TM) Modular Knee System · Johnson & Johnson Professionals, Inc. · 1989 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants K884796 · P.F.C.(TM) Modular Knee System · Johnson & Johnson Professionals, Inc. · 1989 · recalled0
  1. Root · 1 generation backK884796 P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc. · 1989 · Recalled
  2. This deviceK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
  3. Descendant · cites it directly · 3 of its ownK013906 HLS Noetos SystemTornier · 2002
  4. Descendant · cites it directly · 1 of its ownK182301 PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
  5. Descendant · cites it directly · 1 of its ownK094013 HLS Kneetec SystemTornier · 2011
  6. Descendant · cites it directly · 0 of its ownK241000 ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal…Depuy Ireland UC · 2024
  7. Descendant · 2 generations on · 0 of its ownK200765 Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12011: 12012: 12019: 12021: 12024: 1
2002high 1 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K013906HLS Noetos SystemTornier · 2002 · cites it directly3descendants
  • K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019 · cites it directly1descendant
  • K094013HLS Kneetec SystemTornier · 2011 · cites it directly1descendant
  • K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC · 2024 · cites it directly0descendants
  • K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884796P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc.198916
0 (this device)K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc.1999—
+1K013906HLS Noetos SystemTornier2002—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.2019—
+1K094013HLS Kneetec SystemTornier2011—
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem…Depuy Ireland UC2024—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
201110
201210
201910
202110
202410
FIG. 1 — Lineage of K984158, 1989–2024Source: 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? (4)

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
*K884796P.F.C.(TM) Modular Knee System
Summary page 2
…ial Tray is similar in performance, intended use, materials, design, performance characteristics, packaging, and sterilization method to the P.F.C.® Modular Tibial Tray (K884796 and K892394), the P.F.C.® Modular Plus Tibial Tray (K923807), and the Zimmer NexGen® LCCK Knee System (K960279). The determinati…
Johnson & Johnson Professionals, Inc.198916
*K892394P.F.C. Modular Knee System, Tibial Tray-Porous
Summary page 2
…similar in performance, intended use, materials, design, performance characteristics, packaging, and sterilization method to the P.F.C.® Modular Tibial Tray (K884796 and K892394), the P.F.C.® Modular Plus Tibial Tray (K923807), and the Zimmer NexGen® LCCK Knee System (K960279). The determination of substa…
Johnson & Johnson Professionals, Inc.1989—
*K923807P.F.C. Modular Total Knee System, Modular Plus
Summary page 2
…n a range of thicknesses and a variety of surface topographies. The P.F.C.® Modular Plus Offset Tibial Tray and its parent device, the P.F.C.® Modular Plus Tibial Tray (K923807) have the same keel geometry and adjusted cement pockets that accommodate four screw holes for optional wedge attachment. The P.…
Johnson & Johnson International19921
*K960279Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…
Summary page 2
…d sterilization method to the P.F.C.® Modular Tibial Tray (K884796 and K892394), the P.F.C.® Modular Plus Tibial Tray (K923807), and the Zimmer NexGen® LCCK Knee System (K960279). The determination of substantial equivalence for this device is based on a detailed device description, performance testing an…
Zimmer, Inc.199621

Also cleared against K884796: 4 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K013906HLS Noetos SystemTornier20023
K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191
K094013HLS Kneetec SystemTornier20111
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240
K032079HLS Noetos SystemTornier20030

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?

  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K013906 (Tornier, 2002) has gone furthest, with 3 descendants of its own.
  • 4 other devices also cite its predicate K884796.

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.E.C.® Modular Total Knee System is indicated for use as a total knee replacement

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 a result of trauma or failed prior surgical intervention.

The P.F.C.® Modular Plus Offset Tibial Tray is indicated for use with

polymethylmethacrylate (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 K884796

4 other devices cite the same predicate.

  • K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral…Depuy Ireland UC · 2024
  • K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
  • K102367Optigen Total Knee SystemU&I Corp. · 2010
  • K954818Consensus Posterior Stabilized KneeU.S. Medical Products, Inc. · 1996

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

  • P830055/S379ATTUNE Revision Knee SystemDepuy, Inc. · 2026
  • P830055/S377ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System…Depuy, Inc. · 2026
  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, 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/K984158 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984158: P.F.C. Modular Plus Offset 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/K984158

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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