510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Nexgen Complete Knee Solution - Trabecular Metal Augments

K024161510(k) SpecialCleared Jan 15, 200329-day reviewClass II21 CFR 888.3560Recalls 2

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

Implex Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 15, 2003 as substantially equivalent to K982302 (Implex Corp., 1998) after a 29-day review. Its family tree reaches back 1 generation to 1998. 106 later devices descend from it. It has been recalled 2 times.

Decided
Jan 15, 2003
Review
29 days
Class
Class II
Product code
JWH
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K982302 (1998). 106 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2004: 2 descendants cleared2012: 1 descendant cleared2018: 7 descendants cleared2011: 2 descendants cleared2015: 5 descendants cleared2007: 1 descendant cleared2008: 1 descendant cleared2020: 11 descendants cleared2014: 2 descendants cleared2019: 5 descendants cleared2021: 8 descendants cleared2025: 17 descendants cleared2010: 2 descendants cleared2017: 5 descendants cleared2024: 12 descendants cleared2013: 2 descendants cleared2022: 5 descendants cleared2016: 1 descendant cleared2023: 7 descendants cleared2026: 8 descendants clearedK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 13 descendants3 generations forward: 19 descendants4 generations forward: 19 descendants5 generations forward: 29 descendants6 generations forward: 14 descendants7 generations forward: 4 descendants8 generations forward: 2 descendants K982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 19980+5
  1. Root · 1 generation backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. This deviceK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003
  3. Descendant · cites it directly · 85 of its ownK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
  4. Descendant · 2 generations on · 74 of its ownK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  5. Descendant · 3 generations on · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  6. Descendant · 3 generations on · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
  7. Descendant · 4 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2004: 22006: 22007: 12008: 12010: 22011: 22012: 12013: 22014: 22015: 52016: 12017: 52018: 72019: 52020: 112021: 82022: 52023: 72024: 122025: 172026: 8
2004high 17 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 106 · See all
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · cites it directly85descendants
  • K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006 · 2 generations on74descendants
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · 3 generations on53descendants
  • K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · 3 generations on40descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 4 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
0 (this device)K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.2003—
+1K040487Trabecular Metal Knee System AugmentsImplex Corp.20041
+2K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
+3K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
+3K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics20151
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200620
200710
200810
201020
201120
201210
201320
201420
201550
201610
201750
201870
201950
2020110
202180
202250
202370
2024120
2025170
202680
FIG. 1 — Lineage of K024161, 1998–2026Source: 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? (1)

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
*K982302Implex Continuum Knee - Hedrocel Tibial Spacers
Summary page 2
…dicate devices identified in this premarket notification: 510(k) # Product Name Company K982302 Hedrocel Tibial Spacers lmplex Corp. December 16,2002 ( 2…
Implex Corp.1998—

Also cleared against K982302: 1 other device →

What descends from it? (106)

See all 106

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

NumberDeviceApplicantDecidedDescendants
K040487Trabecular Metal Knee System AugmentsImplex Corp.200485
K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619
K033260AequosAap Implantate AG200419
K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc.201111
K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…Zimmer Trabecular Metal Technology20127
K181947Persona Revision Knee SystemZimmer, Inc.20184

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 1, 2019Class IIZ-1005-2019Mixed-up of materials/componentsPotentially comingled, resulting in the product in the box potentially not matching the product on the label
Feb 1, 2019Class IIZ-1006-2019Mixed-up of materials/componentsPotentially comingled, resulting in the product in the box potentially not matching the product on the label

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K040487 (Implex Corp., 2004) has gone furthest, with 85 descendants of its own.
  • 1 other device also cites its predicate K982302.

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 NexGen Trabecular Metal femoral and tibial augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal femoral and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

Indications for use as stated in the FDA summary.

Also cleared against K982302

1 other device cites the same predicate.

  • K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc. · 2011

More from Implex Corp.

65 FDA decisions under this applicant name. See the company

  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 20041 recall
  • K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 20042 recalls
  • K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004

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/K024161 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024161

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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