510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Vanguard XP Knee System

K153657510(k) TraditionalCleared May 10, 2016141-day reviewClass II21 CFR 888.3565Recalls 1

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 May 10, 2016 as substantially equivalent to K141407 (Biomet, Inc., 2014) and 4 other predicates after a 141-day review. Its family tree reaches back 10 generations to 1981. 1 later device descends from it. It has been recalled once.

Decided
May 10, 2016
Review
141 days
Class
Class II
Product code
MBH
Recalls
1
Predicates
5

Its longest line of descent runs back 10 generations to K810258 (1981). 57 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 2 other ancestors2011: 1 other ancestor2006: 3 other ancestors2005: 1 other ancestor2004: 3 other ancestors2003: 5 other ancestors1999: 4 other ancestors1997: 3 other ancestors1993: 2 other ancestors1984: 2 other ancestors2002: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor1996: 3 other ancestors1995: 7 other ancestors1992: 3 other ancestors1989: 1 other ancestor1986: 1 other ancestor1994: 2 other ancestors2019: 1 descendant clearedReference device: K094050 · Itotal CR Knee Replacement System · Conformis, Inc. · 2010Reference device: K092201 · Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial Base · Wrightmedicaltechnologyinc · 2009 · recalledK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK050327 · E-Poly (Vitamin E) Acetabular Liners · Biomet, Inc. · 2005K070364 · 100KGY E-Poly Maxrom Acetabular Liners · Biomet, Inc. · 2007K080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008K113550 · Vanguard Complete Knee System · Biomet Manufacturing Corp · 2012 · recalledK122160 · Vanguard XP Knee System · Biomet Manufacturing Corp · 2013 · recalledK132873 · Vanguard XP Knee System · Biomet, Inc. · 2013 · recalledK141407 · Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial · Biomet, Inc. · 2014 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 12 other ancestors3 generations back: 14 other ancestors4 generations back: 10 other ancestors5 generations back: 1 other ancestor6 generations back: 7 other ancestors7 generations back: 2 other ancestors 1 generation forward: 1 descendant K141407 · Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial · Biomet, Inc. · 2014 · recalledK132873 · Vanguard XP Knee System · Biomet, Inc. · 2013 · recalledK122160 · Vanguard XP Knee System · Biomet Manufacturing Corp · 2013 · recalledK113550 · Vanguard Complete Knee System · Biomet Manufacturing Corp · 2012 · recalledK080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008K070364 · 100KGY E-Poly Maxrom Acetabular Liners · Biomet, Inc. · 2007K050327 · E-Poly (Vitamin E) Acetabular Liners · Biomet, Inc. · 2005K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
  4. 2 generations backK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
  5. 1 generation backK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · Recalled
  6. This deviceK153657 Vanguard XP Knee SystemBiomet, Inc. · 2016
  7. Descendant · cites it directly · 0 of its ownK190068 Vanguard XP Knee SystemZimmer, Inc. · 2019
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 6 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 5 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 4 generations backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  8. 3 generations backK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
  9. 2 generations backK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
  10. 1 generation backK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · Recalled
  11. This deviceK153657 Vanguard XP Knee SystemBiomet, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K190068Vanguard XP Knee SystemZimmer, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−6K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−5K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−4K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
−3K122160Vanguard XP Knee SystemBiomet Manufacturing Corp201312
−2K132873Vanguard XP Knee SystemBiomet, Inc.201322
−1K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.20141
0 (this device)K153657Vanguard XP Knee SystemBiomet, Inc.2016—
+1K190068Vanguard XP Knee SystemZimmer, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198610
198910
199120
199230
199320
199420
199570
199630
199730
199810
199940
200010
200220
200350
200430
200510
200630
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K153657, 1981–2019Source: 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? (5)

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
*K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial
Summary page 4
…Additive semi-constrained cemented prosthesis (21 CFR §888.3560) Legally marketed devices to which substantial equivalence is claimed: ● K141407/K132873/K122160 Vanguard XP Knee System ● K113550 Vanguard Knee System ● K904448 Townley Total Knee Reference Devices for…
Biomet, Inc.20141
*K132873Vanguard XP Knee System
Summary page 4
…semi-constrained cemented prosthesis (21 CFR §888.3560) Legally marketed devices to which substantial equivalence is claimed: ● K141407/K132873/K122160 Vanguard XP Knee System ● K113550 Vanguard Knee System ● K904448 Townley Total Knee Reference Devices for Differen…
Biomet, Inc.201322
*K122160Vanguard XP Knee System
Summary page 4
…nstrained cemented prosthesis (21 CFR §888.3560) Legally marketed devices to which substantial equivalence is claimed: ● K141407/K132873/K122160 Vanguard XP Knee System ● K113550 Vanguard Knee System ● K904448 Townley Total Knee Reference Devices for Differential Bea…
Biomet Manufacturing Corp201312
*K113550Vanguard Complete Knee System
Summary page 4
…prosthesis (21 CFR §888.3560) Legally marketed devices to which substantial equivalence is claimed: ● K141407/K132873/K122160 Vanguard XP Knee System ● K113550 Vanguard Knee System ● K904448 Townley Total Knee Reference Devices for Differential Bearings: ● K094050 ConforMIS iTotal…
Biomet Manufacturing Corp20127
*K904448Townley Total Knee (TTK)
Summary page 4
…3560) Legally marketed devices to which substantial equivalence is claimed: ● K141407/K132873/K122160 Vanguard XP Knee System ● K113550 Vanguard Knee System ● K904448 Townley Total Knee Reference Devices for Differential Bearings: ● K094050 ConforMIS iTotal Cruciate Retaining Knee Replaceme…
Biopro, Inc.1991—
†K094050Itotal CR Knee Replacement SystemConformis, Inc.2010—
†K092201Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial BaseWrightmedicaltechnologyinc20093

Also cleared against K141407: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190068Vanguard XP Knee SystemZimmer, Inc.20190

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 15, 2019Class IIZ-2527-2019Manufacturing material removalThe locking bar not fully engaging

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 23 of the 57 ancestors have a recall of any class.
  • Of its descendants, K190068 (Zimmer, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K141407.

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. 2016, 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?

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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 total joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented…

Read the full statement (93 words)

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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 total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.

*Where Available

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K141407

1 other device cites the same predicate.

  • K190068Vanguard XP Knee SystemZimmer, Inc. · 2019

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/K153657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153657: Vanguard XP Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153657

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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