510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Agc Total Knee Prosthesis

K833921510(k) TraditionalCleared Jan 31, 198478-day reviewClass II21 CFR 888.3560Recalls 2

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 Jan 31, 1984 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 149 later devices descend from it. It has been recalled 2 times.

Decided
Jan 31, 1984
Review
78 days
Class
Class II
Product code
JWH
Recalls
2
Predicates
0

149 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared1997: 1 descendant cleared1999: 1 descendant cleared2004: 2 descendants cleared2003: 1 descendant cleared2009: 1 descendant cleared2010: 2 descendants cleared2021: 19 descendants cleared2006: 2 descendants cleared2014: 11 descendants cleared2008: 1 descendant cleared2012: 5 descendants cleared2017: 6 descendants cleared2013: 9 descendants cleared2016: 11 descendants cleared2025: 13 descendants cleared2020: 7 descendants cleared2026: 8 descendants cleared2018: 6 descendants cleared2015: 7 descendants cleared2023: 11 descendants cleared2019: 8 descendants cleared2022: 7 descendants cleared2024: 8 descendants cleared19801990200020102020
  1. This deviceK833921 Agc Total Knee ProsthesisBiomet, Inc. · 1984
  2. Descendant · cites it directly · 86 of its ownK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  3. Descendant · 2 generations on · 72 of its ownK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
  4. Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  5. Descendant · 2 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  6. Descendant · 2 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12003: 12004: 22006: 22008: 12009: 12010: 22011: 22012: 52013: 92014: 112015: 72016: 112017: 62018: 62019: 82020: 72021: 192022: 72023: 112024: 82025: 132026: 8
1997high 19 (2021) · low 0 (1998)2026

Most influential descendants

Showing 5 of 149 · See all
  • K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003 · cites it directly86descendants
  • K100900Motivation Knee SystemEncore Medical L.P. · 2010 · 2 generations on72descendants
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 2 generations on47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K833921Agc Total Knee ProsthesisBiomet, Inc.1984—
+1K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.2003—
+2K100900Motivation Knee SystemEncore Medical L.P.20104
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200310
200420
200620
200810
200910
201020
201120
201250
201390
2014110
201570
2016110
201760
201860
201980
202070
2021190
202270
2023110
202480
2025130
202680
FIG. 1 — Lineage of K833921, 1984–2026Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (149)

See all 149

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

NumberDeviceApplicantDecidedDescendants
K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.200386
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460
K961021Kirschner Knee ModifiedBiomet, Inc.19977
K984054Agc V2 Revision Knee SystemBiomet, Inc.19992
K094013HLS Kneetec SystemTornier20111

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 25, 2017Class IIZ-0628-2018Process change controlThe affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Aug 25, 2017Class IIZ-0627-2018Process change controlThe affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030686 (Exactech, Inc., 2003) has gone furthest, with 86 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/K833921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K833921: Agc Total Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833921

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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