510(k) Report

510(k) · Cleared

Cleared

Vanguard Anatomic Patella Groove (Apg) / Vanguard V Groove

K061433510(k) TraditionalCleared Aug 21, 200689-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 Manufacturing, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Aug 21, 2006 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 10 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1992.

Decided
Aug 21, 2006
Review
89 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
11

Its longest line of descent runs back 3 generations to K915132 (1992). 27 ancestors in all, the oldest K833921 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 2 other ancestors2003: 4 other ancestors2002: 1 other ancestor1997: 2 other ancestors1993: 1 other ancestor1987: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor1995: 3 other ancestors1991: 1 other ancestor1984: 1 other ancestor1996: 2 other ancestors1989: 1 other ancestor1986: 1 other ancestorK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalledK023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK033489 · Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known · Biomet, Inc. · 2004198019851990199520002005
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 8 other ancestors3 generations back: 7 other ancestors K033489 · Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known · Biomet, Inc. · 2004K023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalled0
  1. Root · 3 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
  2. 2 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
  3. 1 generation backK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  4. This deviceK061433 Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K915132MCK Maximum Congruent Knee) Knee SystemBiomet, Inc.19926
−2K023546Maxim Accel Knee SystemBiomet, Inc.200313
−1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
0 (this device)K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
198720
198910
199110
199310
199530
199620
199720
199810
200010
200210
200340
200420
200510
FIG. 1 — Lineage of K061433, 1992–2006Source: 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? (11)

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
*K023546Maxim Accel Knee System
Summary page 1
…metal/polymer porous-coated uncemented prosthesis (888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard T M (Maxim®~ Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ…
Biomet, Inc.200313
*K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…
Summary page 1
…r porous-coated uncemented prosthesis (888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard T M (Maxim®~ Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis -…
Biomet, Inc.2004—
*K040770Vanguard Patella Components
Summary page 1
…888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard T M (Maxim®~ Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmed…
Biomet Manufacturing, Inc.200413
*K921182Ultra High Molecular Weight Polyethylene Component
Summary page 1
…h Substantial Equivalence Is Claimed: Vanguard T M (Maxim®~ Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K8723…
Biomet, Inc.19933
*K041160Avon Extra-Small Patello-Femoral Replacement
Summary page 1
…M (Maxim®~ Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K87…
Howmedica Osteonics Corp.2004—
*K020841Avon Patellar Component
Summary page 1
…~ Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K874547 (Bio…
Howmedica Osteonics Corp.2002—
*K051948Avon Patello-Femoral Joint Prosthesis
Summary page 1
…23546 and K033489 (Biomet, Inc.), Vanguard T M Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K874547 (Biomet, Inc.), N…
Howmedica Osteonics Corp.20057
*K872379Insall/Burstein* II Modular Total Knee
Summary page 1
…70 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K874547 (Biomet, Inc.), Nexcen® All-Poly Patella - K972270 (Zimmer Holdings), Duracon®…
Zimmer, Inc.198711
*K874547Kirschner Perform Total Knee System Porous Coated
Summary page 1
…et, Inc.), Avon T" PFJ Prosthesis - K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K874547 (Biomet, Inc.), Nexcen® All-Poly Patella - K972270 (Zimmer Holdings), Duracon® CR - K032163 (Stryker/Howmedica/Osteonics) Device…
Kirschner Medical Corp.1987—
*K972270Nexgen Complete Knee Solution Convex Inset Patella Component
Summary page 1
…1, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K874547 (Biomet, Inc.), Nexcen® All-Poly Patella - K972270 (Zimmer Holdings), Duracon® CR - K032163 (Stryker/Howmedica/Osteonics) Device Description: The Vanguard"M Anatomic Patella Groov…
Zimmer, Inc.1997—
*K032163Duracon Total Knee System
Summary page 1
…cs), Insall/Burstein® II - K872379 (Biomet, Inc.), Performance®~ Knee System -K874547 (Biomet, Inc.), Nexcen® All-Poly Patella - K972270 (Zimmer Holdings), Duracon® CR - K032163 (Stryker/Howmedica/Osteonics) Device Description: The Vanguard"M Anatomic Patella Groove (APG) / VanguardT" V Groove product lin…
Howmedica Osteonics Corp.20033

Also cleared against K023546: 14 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • 11 of the 27 ancestors have a recall of any class.
  • 14 other devices also cite its predicate K023546.

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?

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 or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

Indications for use as stated in the FDA summary.

Also cleared against K023546

14 other devices cite the same predicate.

  • K183583Vanguard Complete Knee SystemZimmer, Inc. · 2019
  • K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella…Biomet Manufacturing Corp · 20131 recall
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 20127 recalls
  • K102125Patient-Specific Vanguard Femoral ComponetsBiomet, Inc. · 2011
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  • K080204Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

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/K061433 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061433: Vanguard Anatomic Patella Groove (Apg) / Vanguard V Groove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061433

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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