510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Agc Revision Knee Prothesis

K912245510(k) TraditionalCleared Aug 19, 199190-day reviewClass II21 CFR 888.3560Recalls 3

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 Aug 19, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 71 later devices descend from it. It has been recalled 3 times.

Decided
Aug 19, 1991
Review
90 days
Class
Class II
Product code
JWH
Recalls
3
Predicates
0

71 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2011: 3 descendants cleared1999: 1 descendant cleared2008: 1 descendant cleared2017: 2 descendants cleared2006: 3 descendants cleared2021: 6 descendants cleared2014: 4 descendants cleared2012: 2 descendants cleared2015: 5 descendants cleared2013: 6 descendants cleared2010: 1 descendant cleared2018: 3 descendants cleared2023: 2 descendants cleared2020: 2 descendants cleared2019: 5 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2026: 6 descendants cleared2025: 5 descendants cleared2024: 7 descendants cleared1990200020102020
  1. This deviceK912245 Agc Revision Knee ProthesisBiomet, Inc. · 1991
  2. Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  3. Descendant · cites it directly · 54 of its ownK040770 Vanguard Patella ComponentsBiomet Manufacturing, Inc. · 2004 · Recalled
  4. Descendant · cites it directly · 47 of its ownK061340 23 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc. · 2006
  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 71 descendants. See all descendants

Descendants cleared per year

1999: 12004: 32006: 32008: 12010: 12011: 32012: 22013: 62014: 42015: 52016: 22017: 22018: 32019: 52020: 22021: 62022: 22023: 22024: 72025: 52026: 6
1999high 7 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 71 · See all
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
  • K040770Vanguard Patella ComponentsBiomet Manufacturing, Inc. · 2004 · cites it directly54descendants
  • K06134023 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc. · 2006 · cites it directly47descendants
  • 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)K912245Agc Revision Knee ProthesisBiomet, Inc.1991—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+1K040770Vanguard Patella ComponentsBiomet Manufacturing, Inc.200413
+1K06134023 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc.2006—
+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
199910
200430
200630
200810
201010
201130
201220
201360
201440
201550
201620
201720
201830
201950
202020
202160
202220
202320
202470
202550
202660
FIG. 1 — Lineage of K912245, 1991–2026Source: 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
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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? (71)

See all 71

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

NumberDeviceApplicantDecidedDescendants
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460
K040770Vanguard Patella ComponentsBiomet Manufacturing, Inc.200454
K06134023 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc.200647
K080361Regenerex Tibial ComponentsBiomet, Inc.200813
K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20175
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
Nov 25, 2020Class IIZ-0627-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Mar 1, 2019Class IIZ-1087-2019Packaging process controlTwo lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Mar 1, 2019Class IIZ-1086-2019Packaging process controlTwo lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033489 (Biomet, Inc., 2004) has gone furthest, with 60 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/K912245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912245: Agc Revision Knee Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912245

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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