510(k) Report

510(k) · Cleared

Cleared

Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known

K033489510(k) TraditionalCleared Jun 2, 2004211-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

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

Cleared on Jun 2, 2004 as substantially equivalent to K833921 (Biomet, Inc., 1984) and 8 other predicates after a 211-day review. Its family tree reaches back 2 generations to 1992. 60 later devices descend from it.

Decided
Jun 2, 2004
Review
211 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K915132 (1992). 17 ancestors in all, the oldest K833921 (1984). 60 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 3 other ancestors2000: 1 other ancestor1998: 1 other ancestor1991: 1 other ancestor1984: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1995: 3 other ancestors1989: 1 other ancestor1986: 1 other ancestor2021: 6 descendants cleared2006: 2 descendants cleared2004: 1 descendant cleared2014: 3 descendants cleared2008: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2017: 2 descendants cleared2010: 1 descendant cleared2015: 4 descendants cleared2023: 2 descendants cleared2020: 2 descendants cleared2019: 5 descendants cleared2013: 4 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2026: 6 descendants cleared2024: 7 descendants cleared2025: 5 descendants clearedK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalledK023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 8 other ancestors 1 generation forward: 9 descendants2 generations forward: 20 descendants3 generations forward: 22 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 2 descendants K023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalled0+5
  1. Root · 2 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
  2. 1 generation backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
  3. This deviceK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  4. Descendant · cites it directly · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  5. Descendant · cites it directly · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. Descendant · cites it directly · 13 of its ownK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
  7. Descendant · 2 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
  8. Descendant · 2 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22008: 12010: 12011: 12012: 12013: 42014: 32015: 42016: 22017: 22018: 32019: 52020: 22021: 62022: 22023: 22024: 72025: 52026: 6
2004high 7 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 60 · See all
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · cites it directly47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · cites it directly46descendants
  • K080361Regenerex Tibial ComponentsBiomet, Inc. · 2008 · cites it directly13descendants
  • K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 2 generations on8descendants
  • K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K915132MCK Maximum Congruent Knee) Knee SystemBiomet, Inc.19926
−1K023546Maxim Accel Knee SystemBiomet, Inc.200313
0 (this device)K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+1K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+1K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
+1K080361Regenerex Tibial ComponentsBiomet, Inc.20081
+2K221479Persona Personalized Knee SystemZimmer, Inc.2022—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
198910
199110
199530
199620
199710
199810
200010
200330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200810
201010
201110
201210
201340
201430
201540
201620
201720
201830
201950
202020
202160
202220
202320
202470
202550
202660
FIG. 1 — Lineage of K033489, 1992–2026Source: 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? (9)

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
*K833921Agc Total Knee Prosthesis
Summary page 1
…femorotibial metal/polymer porous coated uncemented (21 CFR 888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGO® Total Knee System Knee (K833921, K91 2245), Ascent"~ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vang…
Biomet, Inc.19842
*K912245Agc Revision Knee Prothesis
Summary page 1
…ial metal/polymer porous coated uncemented (21 CFR 888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGO® Total Knee System Knee (K833921, K91 2245), Ascent"~ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vanguard) (K02…
Biomet, Inc.19913
*K982869Ascent System
Summary page 1
…ted (21 CFR 888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGO® Total Knee System Knee (K833921, K91 2245), Ascent"~ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Pat…
Biomet, Inc.1998—
*K994326Ascent Knee System
Summary page 1
…FR 888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGO® Total Knee System Knee (K833921, K91 2245), Ascent"~ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Patellar Com…
Biomet Manufacturing, Inc.2000—
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 1
…To Which Substantial Equivalence Is Claimed: AGO® Total Knee System Knee (K833921, K91 2245), Ascent"~ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Patellar Components for the NexGen Knee System (K031…
Biomet, Inc.19926
*K023546Maxim Accel Knee System
Summary page 1
…® Total Knee System Knee (K833921, K91 2245), Ascent"~ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Patellar Components for the NexGen Knee System (K031462), Genesis 11Total Knee System (K030612), Pr…
Biomet, Inc.200313
*K031462The Nexgen Knee System Uncemented Components
Summary page 1
…4326), Maxim® Complete Knee System (K9151 32), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Patellar Components for the NexGen Knee System (K031462), Genesis 11Total Knee System (K030612), Profix Total Knee System (K030623) Device Description: All devices are metallic knee fe…
Implex Corp.20034
*K030612Genesis II Total Knee System
Summary page 1
…51 32), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Patellar Components for the NexGen Knee System (K031462), Genesis 11Total Knee System (K030612), Profix Total Knee System (K030623) Device Description: All devices are metallic knee femoral and tibial base-plate components.…
Smith & Nephew, Inc.2003—
*K030623Smith & Nephew Profix Total Knee System
Summary page 1
…nguard) (K023546), Trabecular Metal Tibial and Patellar Components for the NexGen Knee System (K031462), Genesis 11Total Knee System (K030612), Profix Total Knee System (K030623) Device Description: All devices are metallic knee femoral and tibial base-plate components. The components are identical to tho…
Smith & Nephew, Inc.2003—

Also cleared against K833921: 4 other devices →

What descends from it? (60)

See all 60

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

NumberDeviceApplicantDecidedDescendants
K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647
K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp201246
K080361Regenerex Tibial ComponentsBiomet, Inc.200813
K142933Biomet Tibial traysBiomet, Inc.20146
K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20175
K210554Physica systemLima Corporate S.P.A.20212
K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110
K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060
K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040

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 12 years and passes through 1 company; a new generation was cleared every 10.9 years on median.
  • 6 of the 17 ancestors have a recall of any class.
  • Of its descendants, K060303 (Biomet Manufacturing Corp, 2006) has gone furthest, with 47 descendants of its own.
  • 4 other devices also cite its predicate K833921.

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?

The indications for Biomet's Non-Cemented Porous Coated Knee Components include:

1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.

2) Correction of varus, valgus or posttraumatic deformity

3) Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

Indications for use as stated in the FDA summary.

Also cleared against K833921

4 other devices cite the same predicate.

  • K094013HLS Kneetec SystemTornier · 2011
  • K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  • K984054Agc V2 Revision Knee SystemBiomet, Inc. · 1999
  • K961021Kirschner Knee ModifiedBiomet, Inc. · 1997

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K033489 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033489

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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