510(k) Report

510(k) · Cleared

Cleared

Vanguard 360 Revision Knee System

K143192510(k) TraditionalCleared Feb 12, 201598-day reviewClass II21 CFR 888.3560

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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 12, 2015 as substantially equivalent to K093293 (Biomet, Inc., 2010) after a 98-day review. Its family tree reaches back 4 generations to 1992.

Decided
Feb 12, 2015
Review
98 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K915132 (1992). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1995: 1 other ancestorK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalledK023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK042757 · Vanguard SSK Knee System · Biomet, Inc. · 2005 · recalledK093293 · Vanguard 360 Revision Knee System · Biomet, Inc. · 2010 · recalled199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor4 generations back: 1 other ancestor K093293 · Vanguard 360 Revision Knee System · Biomet, Inc. · 2010 · recalledK042757 · Vanguard SSK Knee System · Biomet, Inc. · 2005 · recalledK023546 · Maxim Accel Knee System · Biomet, Inc. · 2003 · recalledK915132 · MCK Maximum Congruent Knee) Knee System · Biomet, Inc. · 1992 · recalled0
  1. Root · 4 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
  2. 3 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
  3. 2 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
  4. 1 generation backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
  5. This deviceK143192 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K915132MCK Maximum Congruent Knee) Knee SystemBiomet, Inc.19926
−3K023546Maxim Accel Knee SystemBiomet, Inc.200313
−2K042757Vanguard SSK Knee SystemBiomet, Inc.20051
−1K093293Vanguard 360 Revision Knee SystemBiomet, Inc.20105
0 (this device)K143192Vanguard 360 Revision Knee SystemBiomet, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110
FIG. 1 — Lineage of K143192, 1992–2015Source: 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 JWH? 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 JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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? (1)

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
*K093293Vanguard 360 Revision Knee System
Summary page 4
…WPE, Pegged,cemented, polymer/metal/polymer (21 CFR §888.3560) Legally marketed devices to which substantial equivalence is claimed:  K093293 Vanguard 360 Revision Knee System Device Description The Vanguard 360 Revision Knee System is a total knee replacement system in…
Biomet, Inc.20105

Also cleared against K093293: 5 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 23 years and passes through 1 company; a new generation was cleared every 5.7 years on median.
  • 5 of the 6 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K093293.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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. The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are…

Read the full statement (155 words)

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.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

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 and OsseoTi components are intended only for uncemented biologic fixation application.

The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States or Canada.

Indications for use as stated in the FDA summary.

Also cleared against K093293

5 other devices cite the same predicate.

  • K181947Persona Revision Knee SystemZimmer, Inc. · 20181 recall
  • K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc. · 2014
  • K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation · 2013
  • K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
  • K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012

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 JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K143192 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143192: Vanguard 360 Revision 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/K143192

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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