510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Trabecular Metal Knee System Augments

K040487510(k) TraditionalCleared Dec 21, 2004300-day reviewClass II21 CFR 888.3565Recalls 1

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

Implex Corp. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Dec 21, 2004 as substantially equivalent to K024161 (Implex Corp., 2003) after a 300-day review. Its family tree reaches back 2 generations to 1998. 85 later devices descend from it. It has been recalled once.

Decided
Dec 21, 2004
Review
300 days
Class
Class II
Product code
MBH
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K982302 (1998). 85 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2012: 1 descendant cleared2011: 2 descendants cleared2010: 2 descendants cleared2007: 1 descendant cleared2017: 5 descendants cleared2020: 9 descendants cleared2018: 7 descendants cleared2015: 2 descendants cleared2008: 1 descendant cleared2014: 2 descendants cleared2024: 10 descendants cleared2013: 2 descendants cleared2022: 3 descendants cleared2019: 4 descendants cleared2025: 14 descendants cleared2016: 1 descendant cleared2023: 5 descendants cleared2021: 5 descendants cleared2026: 7 descendants clearedK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 1998K024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 13 descendants3 generations forward: 22 descendants4 generations forward: 29 descendants5 generations forward: 11 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 2 descendants K024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 19980+5
  1. Root · 2 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 1 generation backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
  3. This deviceK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004
  4. Descendant · cites it directly · 74 of its ownK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  5. Descendant · 2 generations on · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  6. Descendant · 2 generations on · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
  7. Descendant · 3 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  8. Descendant · cites it directly · 19 of its ownK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 12010: 22011: 22012: 12013: 22014: 22015: 22016: 12017: 52018: 72019: 42020: 92021: 52022: 32023: 52024: 102025: 142026: 7
2006high 14 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 85 · See all
  • K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006 · cites it directly74descendants
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · 2 generations on53descendants
  • K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · 2 generations on40descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 3 generations on24descendants
  • K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006 · cites it directly19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
−1K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20032
0 (this device)K040487Trabecular Metal Knee System AugmentsImplex Corp.2004—
+1K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
+2K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
+2K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics20151
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+1K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200810
201020
201120
201210
201320
201420
201520
201610
201750
201870
201940
202090
202150
202230
202350
2024100
2025140
202670
FIG. 1 — Lineage of K040487, 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 MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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
*K024161Nexgen Complete Knee Solution - Trabecular Metal Augments
Summary page 1
…or their application by the courts. Predicate Devices: The NexGen Trabecular Metal Knee System Augments (K024161). February 23, 2004 Page - 44 - Implex Corp…
Implex Corp.20032

Also cleared against K024161: 5 other devices →

What descends from it? (85)

See all 85

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

NumberDeviceApplicantDecidedDescendants
K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular200674
K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619
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

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 4, 2015Class IIZ-1325-2015Error in labelingOne unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K053340 (Zimmer Trabecular, 2006) has gone furthest, with 74 descendants of its own.
  • 5 other devices also cite its predicate K024161.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

Trabecular Metal Knee System Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

Indications for use as stated in the FDA summary.

Also cleared against K024161

5 other devices cite the same predicate.

  • K181947Persona Revision Knee SystemZimmer, Inc. · 20181 recall
  • K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM)…Zimmer Trabecular Metal Technology · 20121 recall
  • K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc. · 2011
  • K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
  • K033260AequosAap Implantate AG · 2004

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
  • K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 20042 recalls
  • K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004
  • K031962Nexgen Trabecular Metal Tibial Cone AugmentsImplex Corp. · 2004

Recent decisions in MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K040487 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040487: Trabecular Metal Knee System Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040487

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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