510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

MCK Maximum Congruent Knee) Knee System

K915132510(k) TraditionalCleared Feb 11, 199290-day reviewClass II21 CFR 888.3560Recalls 6

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 11, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 315 later devices descend from it. It has been recalled 6 times.

Decided
Feb 11, 1992
Review
90 days
Class
Class II
Product code
JWH
Recalls
6
Predicates
0

315 later devices descend from it, 14 citing it directly.

Descendants, by year cleared 2004: 5 descendants cleared1997: 2 descendants cleared2006: 4 descendants cleared2007: 2 descendants cleared1999: 1 descendant cleared2014: 19 descendants cleared2011: 7 descendants cleared2010: 6 descendants cleared2003: 1 descendant cleared2017: 11 descendants cleared2005: 2 descendants cleared2008: 3 descendants cleared2019: 20 descendants cleared2013: 16 descendants cleared2012: 11 descendants cleared2021: 26 descendants cleared2015: 17 descendants cleared2018: 12 descendants cleared2020: 19 descendants cleared2024: 22 descendants cleared2023: 21 descendants cleared2022: 23 descendants cleared2016: 15 descendants cleared2026: 22 descendants cleared2025: 28 descendants cleared1990200020102020
  1. This deviceK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992
  2. Descendant · cites it directly · 305 of its ownK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 255 of its ownK050222 Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 249 of its ownK041046 Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc. · 2004 · Recalled
  5. Descendant · 2 generations on · 248 of its ownK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  6. Descendant · 3 generations on · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled

Showing 5 of 315 descendants. See all descendants

Descendants cleared per year

1997: 21999: 12003: 12004: 52005: 22006: 42007: 22008: 32010: 62011: 72012: 112013: 162014: 192015: 172016: 152017: 112018: 122019: 202020: 192021: 262022: 232023: 212024: 222025: 282026: 22
1997high 28 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 315 · See all
  • K023546Maxim Accel Knee SystemBiomet, Inc. · 2003 · cites it directly305descendants
  • K050222Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc. · 2005 · 2 generations on255descendants
  • K041046Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc. · 2004 · 2 generations on249descendants
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008 · 2 generations on248descendants
  • K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · 3 generations on119descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915132MCK Maximum Congruent Knee) Knee SystemBiomet, Inc.1992—
+1K023546Maxim Accel Knee SystemBiomet, Inc.200313
+2K050222Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc.20051
+2K041046Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc.20041
+2K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
+3K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20104

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
200310
200450
200520
200640
200720
200830
201060
201170
2012110
2013160
2014190
2015170
2016150
2017110
2018120
2019200
2020190
2021260
2022230
2023210
2024220
2025280
2026220
FIG. 1 — Lineage of K915132, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (315)

See all 315

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

NumberDeviceApplicantDecidedDescendants
K023546Maxim Accel Knee SystemBiomet, Inc.2003305
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460
K042757Vanguard SSK Knee SystemBiomet, Inc.200523
K093293Vanguard 360 Revision Knee SystemBiomet, Inc.201021
K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619
K102580Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp20119
K961021Kirschner Knee ModifiedBiomet, Inc.19977
K142933Biomet Tibial traysBiomet, Inc.20146
K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20175
K984054Agc V2 Revision Knee SystemBiomet, Inc.19992

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

Recalls of this device

DateClassRecallRoot causeReason
May 18, 2018Class IIZ-2177-2018Under Investigation by firmOne lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
Apr 16, 2015Class IIIZ-1756-2015Labeling mix-upsBiomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Mar 3, 2011Not classifiedZ-2104-2011Packaging process controlThe firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
Dec 12, 2007Not classifiedZ-0706-2008Packaging process controlMislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
Dec 12, 2007Not classifiedZ-0707-2008Packaging process controlMislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
Sep 18, 2007Not classifiedZ-0255-2008Labeling mix-upsMislabeled as to size: the package actaully contained a 71 mm tray.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K023546 (Biomet, Inc., 2003) has gone furthest, with 305 descendants of its own.

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.

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—

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/K915132 · printed Nov 5, 2026

Cite this page

510(k) Report. “K915132: MCK Maximum Congruent Knee) Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915132

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026