510(k) Report

510(k) · Cleared

Cleared

Trabecular Metal Femoral Cone Augments

K103517510(k) TraditionalCleared Feb 15, 201177-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 Metal Technology, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Feb 15, 2011 as substantially equivalent to K040630 (Implex Corp., 2004) and 7 other predicates after a 77-day review. Its family tree reaches back 4 generations to 1998. 11 later devices descend from it.

Decided
Feb 15, 2011
Review
77 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
8

Its longest line of descent runs back 4 generations to K982302 (1998). 9 ancestors in all, the oldest K980781 (1998). 11 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 2 other ancestors1998: 1 other ancestor2003: 1 other ancestor2020: 3 descendants cleared2018: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2025: 2 descendants cleared2024: 2 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 · recalledK053340 · Trabecular Metal Tibial and Femoral Cone Augments · Zimmer Trabecular · 20061995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K053340 · Trabecular Metal Tibial and Femoral Cone Augments · Zimmer Trabecular · 2006K040487 · 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
  1. Root · 4 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 3 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
  3. 2 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
  4. 1 generation backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  5. This deviceK103517 Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc. · 2011
  6. Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
  7. Descendant · cites it directly · 3 of its ownK200653 AMF Revision TT ConesLima Corporate S.P.A. · 2020
  8. Descendant · 2 generations on · 1 of its ownK240324 EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis) · 2024
  9. Descendant · 2 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
  10. Descendant · 3 generations on · 0 of its ownK251241 EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P. · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 32021: 22024: 22025: 2
2018high 3 (2020) · low 0 (2022)2026

Most influential descendants

Showing 5 of 11 · See all
  • K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
  • K200653AMF Revision TT ConesLima Corporate S.P.A. · 2020 · cites it directly3descendants
  • K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis) · 2024 · 2 generations on1descendant
  • K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 2 generations on1descendant
  • K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
−3K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20032
−2K040487Trabecular Metal Knee System AugmentsImplex Corp.20041
−1K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
0 (this device)K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc.2011—
+1K181947Persona Revision Knee SystemZimmer, Inc.20181
+1K200653AMF Revision TT ConesLima Corporate S.P.A.2020—
+2K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)2024—
+2K191625Persona Revision Knee SystemZimmer, Inc.20191
+3K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202030
202120
202420
202520
FIG. 1 — Lineage of K103517, 1998–2025Source: 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? (8)

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
*K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ
Summary page 2
…ne Augments were shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are Zimmer's Trabecular Metalrm Femoral Cone Augments (K040630, KO051756, K053340), Zimmer's NexGen®iTrabecular MetalTm Tibial Cone Augments (K03 1962, K053340), Zimmer's NexGen®tt Complete Kn…
Implex Corp.20042
*K051756Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ
Summary page 2
…were shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are Zimmer's Trabecular Metalrm Femoral Cone Augments (K040630, KO051756, K053340), Zimmer's NexGen®iTrabecular MetalTm Tibial Cone Augments (K03 1962, K053340), Zimmer's NexGen®tt Complete Knee Solutio…
Zimmer Trabecular2005—
*K053340Trabecular Metal Tibial and Femoral Cone Augments
Summary page 2
…own to be substantially equivalent to legally marketed predicate devices. The predicate devices are Zimmer's Trabecular Metalrm Femoral Cone Augments (K040630, KO051756, K053340), Zimmer's NexGen®iTrabecular MetalTm Tibial Cone Augments (K03 1962, K053340), Zimmer's NexGen®tt Complete Knee Solution - Trabe…
Zimmer Trabecular2006—
*K031962Nexgen Trabecular Metal Tibial Cone Augments
Summary page 2
…ices. The predicate devices are Zimmer's Trabecular Metalrm Femoral Cone Augments (K040630, KO051756, K053340), Zimmer's NexGen®iTrabecular MetalTm Tibial Cone Augments (K03 1962, K053340), Zimmer's NexGen®tt Complete Knee Solution - Trabecular MetalTM Augments (K02416 1, K040487), Zimmer's (formerly Implex…
Implex Corp.2004—
*K024161Nexgen Complete Knee Solution - Trabecular Metal Augments
Summary page 2
…O051756, K053340), Zimmer's NexGen®iTrabecular MetalTm Tibial Cone Augments (K03 1962, K053340), Zimmer's NexGen®tt Complete Knee Solution - Trabecular MetalTM Augments (K02416 1, K040487), Zimmer's (formerly Implex) Continuum Knee System Trabecular MetalTM (formerly Hedrocel®)Tibial Spacers (K982302), and…
Implex Corp.20032
*K040487Trabecular Metal Knee System Augments
Summary page 2
…053340), Zimmer's NexGen®iTrabecular MetalTm Tibial Cone Augments (K03 1962, K053340), Zimmer's NexGen®tt Complete Knee Solution - Trabecular MetalTM Augments (K02416 1, K040487), Zimmer's (formerly Implex) Continuum Knee System Trabecular MetalTM (formerly Hedrocel®)Tibial Spacers (K982302), and Zimmer's…
Implex Corp.20041
*K982302Implex Continuum Knee - Hedrocel Tibial Spacers
Summary page 2
…Knee Solution - Trabecular MetalTM Augments (K02416 1, K040487), Zimmer's (formerly Implex) Continuum Knee System Trabecular MetalTM (formerly Hedrocel®)Tibial Spacers (K982302), and Zimmer's (formerly Implex) Continuum Knee System Trabecular MetalTM (formerly Hedrocel®) Revision Femoral Spacers (K098078…
Implex Corp.1998—
*K980781Implex Continuum Knee- Hedrocel Revision Femoral SpacersImplex Corp.1998—

Also cleared against K040630: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K181947Persona Revision Knee SystemZimmer, Inc.20184
K200653AMF Revision TT ConesLima Corporate S.P.A.20203
K201364LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG20200
K2000753DMetal Diaphyseal Femoral ConesMedacta International S.A.20200

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 13 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
  • 4 of the 9 ancestors have a recall of any class.
  • Of its descendants, K181947 (Zimmer, Inc., 2018) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K040630.

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. 2011, this device’s year, is highlighted.

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

Indications for use as stated in the FDA summary.

Also cleared against K040630

2 other devices cite the same predicate.

  • K181947Persona Revision Knee SystemZimmer, Inc. · 20181 recall
  • K051756Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZZimmer Trabecular · 2005

More from Zimmer Trabecular Metal Technology, Inc.

2 FDA decisions under this applicant name. See the company

  • K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc. · 2012

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/K103517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103517: Trabecular Metal Femoral Cone Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103517

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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