510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Vanguard XP Knee System

K122160510(k) TraditionalCleared Mar 20, 2013243-day reviewClass II21 CFR 888.3565Recalls 12

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Mar 20, 2013 as substantially equivalent to K113550 (Biomet Manufacturing Corp, 2012) and 9 other predicates after a 243-day review. Its family tree reaches back 7 generations to 1981. 6 later devices descend from it. It has been recalled 12 times.

Decided
Mar 20, 2013
Review
243 days
Class
Class II
Product code
MBH
Recalls
12
Predicates
10

Its longest line of descent runs back 7 generations to K810258 (1981). 54 ancestors in all. 6 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2005: 1 other ancestor2003: 5 other ancestors1999: 4 other ancestors1997: 3 other ancestors1993: 2 other ancestors1991: 2 other ancestors1984: 2 other ancestors2006: 3 other ancestors2004: 3 other ancestors2002: 2 other ancestors1996: 3 other ancestors1995: 7 other ancestors1992: 3 other ancestors2000: 1 other ancestor1998: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1994: 2 other ancestors2014: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2016: 1 descendant clearedK810258 · 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 11 other ancestors3 generations back: 11 other ancestors4 generations back: 8 other ancestors5 generations back: 7 other ancestors6 generations back: 2 other ancestors 1 generation forward: 6 descendants K113550 · 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. · 1981−50
  1. Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 4 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 3 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 2 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 1 generation backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  8. This deviceK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013
  9. Descendant · cites it directly · 3 of its ownK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
  10. Descendant · cites it directly · 2 of its ownK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · Recalled
  11. Descendant · cites it directly · 1 of its ownK153657 Vanguard XP Knee SystemBiomet, Inc. · 2016 · Recalled
  12. Descendant · cites it directly · 0 of its ownK190068 Vanguard XP Knee SystemZimmer, Inc. · 2019
  13. Descendant · cites it directly · 0 of its ownK143635 KINETIS Total Knee SystemMako Surgical · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22015: 12016: 12019: 1
2013high 2 (2014) · low 0 (2017)2026

Most influential descendants

Showing 5 of 6 · See all
  • K132873Vanguard XP Knee SystemBiomet, Inc. · 2013 · cites it directly3descendants
  • K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · cites it directly2descendants
  • K153657Vanguard XP Knee SystemBiomet, Inc. · 2016 · cites it directly1descendant
  • K190068Vanguard XP Knee SystemZimmer, Inc. · 2019 · cites it directly0descendants
  • K143635KINETIS Total Knee SystemMako Surgical · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−6K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−5K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−4K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−3K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−2K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−1K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
0 (this device)K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013—
+1K132873Vanguard XP Knee SystemBiomet, Inc.201322
+1K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.20141
+1K153657Vanguard XP Knee SystemBiomet, Inc.20161
+1K190068Vanguard XP Knee SystemZimmer, Inc.2019—
+1K143635KINETIS Total Knee SystemMako Surgical2015—

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
201310
201420
201510
201610
201910
FIG. 1 — Lineage of K122160, 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 20.0 · 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? (10)

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
*K113550Vanguard Complete Knee System
Summary page 1
…sis (§888.3560) Classification panel Orthopedic equivalence is claimed Regulation 21CFR §888.3565 21CFR §888.3560 Product Code(s) JWH, MBH, MBV, OIY Legally marketed K113550 Vanguard"u Knee System (JWH, MBH, OIY) device(s) to which K102580 Vanguard~ Removable Molded Poly Tibia (JWH) K080528 E1™ Tibial…
Biomet Manufacturing Corp20127
*K102580Vanguard Removable Molded Poly Tibia
Summary page 1
…claimed Regulation 21CFR §888.3565 21CFR §888.3560 Product Code(s) JWH, MBH, MBV, OIY Legally marketed K113550 Vanguard"u Knee System (JWH, MBH, OIY) device(s) to which K102580 Vanguard~ Removable Molded Poly Tibia (JWH) K080528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) K904448 Townley Total Knee (JWH) K…
Biomet Manufacturing Corp2011—
*K080528E-Poly Tibial Bearings
Summary page 1
…roduct Code(s) JWH, MBH, MBV, OIY Legally marketed K113550 Vanguard"u Knee System (JWH, MBH, OIY) device(s) to which K102580 Vanguard~ Removable Molded Poly Tibia (JWH) K080528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) K904448 Townley Total Knee (JWH) K833363 Cloutier II Fiber Metal Total Knee (JWH) K0310…
Biomet Orthopedics, Inc.2008—
*K904448Townley Total Knee (TTK)
Summary page 1
…d K113550 Vanguard"u Knee System (JWH, MBH, OIY) device(s) to which K102580 Vanguard~ Removable Molded Poly Tibia (JWH) K080528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) K904448 Townley Total Knee (JWH) K833363 Cloutier II Fiber Metal Total Knee (JWH) K031061 NexGen® Total Knee System (MBH) K050222 Vangu…
Biopro, Inc.1991—
*K833363Cloutier II Fiber Metal Total Knee
Summary page 1
…JWH, MBH, OIY) device(s) to which K102580 Vanguard~ Removable Molded Poly Tibia (JWH) K080528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) K904448 Townley Total Knee (JWH) K833363 Cloutier II Fiber Metal Total Knee (JWH) K031061 NexGen® Total Knee System (MBH) K050222 Vanguard™ Anterior Stabilized Tibial Be…
Zimmer, Inc.1984—
*K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components
Summary page 1
…d~ Removable Molded Poly Tibia (JWH) K080528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) K904448 Townley Total Knee (JWH) K833363 Cloutier II Fiber Metal Total Knee (JWH) K031061 NexGen® Total Knee System (MBH) K050222 Vanguard™ Anterior Stabilized Tibial Bearings Mailing Address: P.0. Box 587 Warsaw, I…
Zimmer, Inc.200324
*K050222Vanguard Anterior Stabilized Tibial Bearings
Summary page 1
…0528 E1™ Tibial Bearings (OIY, JWH, MBH, MBV) K904448 Townley Total Knee (JWH) K833363 Cloutier II Fiber Metal Total Knee (JWH) K031061 NexGen® Total Knee System (MBH) K050222 Vanguard™ Anterior Stabilized Tibial Bearings Mailing Address: P.0. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Offi…
Biomet, Inc.20051
*K961021Kirschner Knee Modified
Summary page 2
…639 Main Fax: 574.267.8137 www.biomet.com Shipping Address: 56 East Bell Drive Warsaw, IN 46582 13 K122160 (page 2/4) MANUFACTURING CORP. (JWH, MBH) K961021 Kirschner Knee Mcdified (JWH) K921182 Ultra High Molecular Weight Polyethylene (JWH, HRY) K993159 Maxim Knee System (JWH) Reas…
Biomet, Inc.1997—
*K921182Ultra High Molecular Weight Polyethylene Component
Summary page 2
…om Shipping Address: 56 East Bell Drive Warsaw, IN 46582 13 K122160 (page 2/4) MANUFACTURING CORP. (JWH, MBH) K961021 Kirschner Knee Mcdified (JWH) K921182 Ultra High Molecular Weight Polyethylene (JWH, HRY) K993159 Maxim Knee System (JWH) Reason for 510(k) submission Additional Va…
Biomet, Inc.19933
*K993159Maxim Knee System
Summary page 2
…K122160 (page 2/4) MANUFACTURING CORP. (JWH, MBH) K961021 Kirschner Knee Mcdified (JWH) K921182 Ultra High Molecular Weight Polyethylene (JWH, HRY) K993159 Maxim Knee System (JWH) Reason for 510(k) submission Additional Vanguard® product line to include an XP femoral, ACL/PCL and PC…
Biomet, Inc.1999—

Also cleared against K113550: 17 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K132873Vanguard XP Knee SystemBiomet, Inc.20133
K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.20142
K153657Vanguard XP Knee SystemBiomet, Inc.20161
K190068Vanguard XP Knee SystemZimmer, Inc.20190
K143635KINETIS Total Knee SystemMako Surgical20150
K140257Signature Planner, Signature GuidesMaterialise NV20140

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 15, 2019Class IIZ-2503-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2528-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2537-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2533-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2532-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2535-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2515-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2530-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2536-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2531-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2534-2019Manufacturing material removalThe locking bar not fully engaging
Aug 15, 2019Class IIZ-2529-2019Manufacturing material removalThe locking bar not fully engaging

The 5 latest of 12 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 20 of the 54 ancestors have a recall of any class.
  • Of its descendants, K132873 (Biomet, Inc., 2013) has gone furthest, with 3 descendants of its own.
  • 17 other devices also cite its predicate K113550.

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. 2013, 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 biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.

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 K113550

17 other devices cite the same predicate.

  • K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd. · 2026
  • K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A. · 2023
  • K221479Persona Personalized Knee SystemZimmer, Inc. · 2022
  • K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd. · 2022
  • K210554Physica systemLima Corporate S.P.A. · 2021
  • K201084Physica systemLima Corporate S.P.A. · 2020

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

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/K122160 · printed Nov 4, 2026

Cite this page

510(k) Report. “K122160: Vanguard XP Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122160

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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