510(k) Report

510(k) · Cleared

Cleared

Trabecular Metal Tibial and Femoral Cone Augments

K053340510(k) TraditionalCleared Feb 27, 200688-day reviewClass II21 CFR 888.3565

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

Zimmer Trabecular · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Feb 27, 2006 as substantially equivalent to K031962 (Implex Corp., 2004) and 3 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1998. 74 later devices descend from it.

Decided
Feb 27, 2006
Review
88 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K982302 (1998). 7 ancestors in all. 74 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 2 other ancestors2003: 1 other ancestor2010: 1 descendant cleared2007: 1 descendant cleared2017: 3 descendants cleared2012: 1 descendant cleared2011: 2 descendants cleared2020: 9 descendants cleared2018: 7 descendants cleared2015: 1 descendant cleared2014: 2 descendants cleared2024: 10 descendants cleared2013: 1 descendant cleared2022: 3 descendants cleared2019: 3 descendants cleared2025: 13 descendants cleared2016: 1 descendant cleared2023: 5 descendants cleared2021: 4 descendants cleared2026: 7 descendants clearedK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 1998K024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK040487 · Trabecular Metal Knee System Augments · Implex Corp. · 2004 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 20 descendants3 generations forward: 30 descendants4 generations forward: 13 descendants5 generations forward: 2 descendants K040487 · Trabecular Metal Knee System Augments · Implex Corp. · 2004 · recalledK024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 19980+5
  1. Root · 3 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 2 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
  3. 1 generation backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
  4. This deviceK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  5. Descendant · cites it directly · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  6. Descendant · cites it directly · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
  7. Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  8. Descendant · 3 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  9. Descendant · 3 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12011: 22012: 12013: 12014: 22015: 12016: 12017: 32018: 72019: 32020: 92021: 42022: 32023: 52024: 102025: 132026: 7
2007high 13 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 74 · See all
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · cites it directly53descendants
  • K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · cites it directly40descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 3 generations on14descendants
  • K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
−2K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20032
−1K040487Trabecular Metal Knee System AugmentsImplex Corp.20041
0 (this device)K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
+1K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
+1K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics20151
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+3K173849Triathlon Total Knee SystemStryker Orthopaedics20183
+3K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201120
201210
201310
201420
201510
201610
201730
201870
201930
202090
202140
202230
202350
2024100
2025130
202670
FIG. 1 — Lineage of K053340, 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 20.0 · 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? (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
*K031962Nexgen Trabecular Metal Tibial Cone Augments
Summary page 1
…terest under the US Patent Laws or their application by the courts. Predicate Devices: Trabecular Metal Tibial Cone Augments (K031962) Trabecular Metal Femoral Cone Augments (K051756), Trabecular Metal…
Implex Corp.2004—
*K051756Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ
Summary page 1
…ion by the courts. Predicate Devices: Trabecular Metal Tibial Cone Augments (K031962) Trabecular Metal Femoral Cone Augments (K051756), Trabecular Metal Knee System Augments (K040487) NexGen Knee Syste…
Zimmer Trabecular2005—
*K040487Trabecular Metal Knee System Augments
Summary page 1
…Augments (K031962) Trabecular Metal Femoral Cone Augments (K051756), Trabecular Metal Knee System Augments (K040487) NexGen Knee System Uncemented Components (K031462). November…
Implex Corp.20041
*K031462The Nexgen Knee System Uncemented Components
Summary page 1
…Trabecular Metal Knee System Augments (K040487) NexGen Knee System Uncemented Components (K031462). November 28, 2005 Page - 43 - Zimm…
Implex Corp.20034

Also cleared against K031962: 3 other devices →

What descends from it? (74)

See all 74

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

NumberDeviceApplicantDecidedDescendants
K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053
K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics201540
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
K162775Legion Cone SystemSmith & Nephew, Inc.20175
K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074
K200653AMF Revision TT ConesLima Corporate S.P.A.20203
K182085Balanced Knee Revision System Trabecular Tibial Cone AugmentsOrtho Development Corporation20180
K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110

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 8 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • 4 of the 7 ancestors have a recall of any class.
  • Of its descendants, K100391 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 53 descendants of its own.
  • 3 other devices also cite its predicate K031962.

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 Tibial Cone Augments and Trabecular Metal Femoral Cone 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 Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Ksiee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

Indications for use as stated in the FDA summary.

Also cleared against K031962

3 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

More from Zimmer Trabecular

10 FDA decisions under this applicant name. See the company

  • K061155Vista P Vertebral Body Replacement SystemZimmer Trabecular · 2006
  • K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular · 20064 recalls
  • K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005
  • K051756Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZZimmer Trabecular · 2005
  • K050766Explant Osteonecrosis Intervention Implant Removal SystemZimmer Trabecular · 2005

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/K053340 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053340: Trabecular Metal Tibial and Femoral Cone Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053340

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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