510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

The Nexgen Knee System Uncemented Components

K031462510(k) TraditionalCleared Aug 6, 200390-day reviewClass II21 CFR 888.3565Recalls 4

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 Aug 6, 2003 after a 90-day review. The FDA summary names its predicate without a number. 128 later devices descend from it. It has been recalled 4 times.

Decided
Aug 6, 2003
Review
90 days
Class
Class II
Product code
MBH
Recalls
4
Predicates
0

128 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2004: 2 descendants cleared2008: 1 descendant cleared2024: 16 descendants cleared2021: 8 descendants cleared2014: 5 descendants cleared2012: 2 descendants cleared2011: 3 descendants cleared2017: 5 descendants cleared2010: 2 descendants cleared2007: 1 descendant cleared2020: 11 descendants cleared2018: 9 descendants cleared2015: 5 descendants cleared2013: 5 descendants cleared2022: 5 descendants cleared2023: 7 descendants cleared2019: 7 descendants cleared2016: 3 descendants cleared2026: 11 descendants cleared2025: 17 descendants cleared200020052010201520202025
  1. This deviceK031462 The Nexgen Knee System Uncemented ComponentsImplex Corp. · 2003
  2. Descendant · cites it directly · 74 of its ownK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  3. Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  4. Descendant · 2 generations on · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  5. Descendant · 2 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  6. Descendant · 2 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

2004: 22006: 32007: 12008: 12010: 22011: 32012: 22013: 52014: 52015: 52016: 32017: 52018: 92019: 72020: 112021: 82022: 52023: 72024: 162025: 172026: 11
2004high 17 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 128 · See all
  • K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006 · cites it directly74descendants
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · 2 generations on53descendants
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 2 generations on47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031462The Nexgen Knee System Uncemented ComponentsImplex Corp.2003—
+1K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular2006—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+2K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200630
200710
200810
201020
201130
201220
201350
201450
201550
201630
201750
201890
201970
2020110
202180
202250
202370
2024160
2025170
2026110
FIG. 1 — Lineage of K031462, 2003–2026Source: 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? (3)

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
*—NexGen TMT Tibia
Named without a submission number
—
*—LPS Tibia
Named without a submission number
—
*—Primary Porous Patella
Named without a submission number
—

What descends from it? (128)

See all 128

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
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460
K080361Regenerex Tibial ComponentsBiomet, Inc.200813
K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 15, 2016Class IIZ-1951-2016Unknown/Undetermined by firmZimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile…
Apr 15, 2016Class IIZ-1953-2016Unknown/Undetermined by firmZimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile…
Apr 15, 2016Class IIZ-1950-2016Unknown/Undetermined by firmZimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile…
Apr 15, 2016Class IIZ-1952-2016Unknown/Undetermined by firmZimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053340 (Zimmer Trabecular, 2006) has gone furthest, with 74 descendants of its own.

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 and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty.

Indications for use as stated in the FDA summary.

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 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/K031462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031462: The Nexgen Knee System Uncemented Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031462

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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