510(k) Report

510(k) · Cleared

Cleared

Agc V2 Revision Knee System

K984054510(k) TraditionalCleared Jul 30, 1999259-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 Jul 30, 1999 as substantially equivalent to K833921 (Biomet, Inc., 1984) and 2 other predicates after a 259-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.

Decided
Jul 30, 1999
Review
259 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K833921 (1984). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor1991: 1 other ancestor2011: 1 descendant cleared2012: 1 descendant clearedK833921 · Agc Total Knee Prosthesis · Biomet, Inc. · 1984 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K833921 · Agc Total Knee Prosthesis · Biomet, Inc. · 1984 · recalled0
  1. Root · 1 generation backK833921 Agc Total Knee ProsthesisBiomet, Inc. · 1984 · Recalled
  2. This deviceK984054 Agc V2 Revision Knee SystemBiomet, Inc. · 1999
  3. Descendant · cites it directly · 1 of its ownK094013 HLS Kneetec SystemTornier · 2011
  4. Descendant · 2 generations on · 0 of its ownK111970 Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K094013HLS Kneetec SystemTornier · 2011 · cites it directly1descendant
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K833921Agc Total Knee ProsthesisBiomet, Inc.19842
0 (this device)K984054Agc V2 Revision Knee SystemBiomet, Inc.1999—
+1K094013HLS Kneetec SystemTornier2011—
+2K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
FIG. 1 — Lineage of K984054, 1984–2012Source: 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? (3)

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
*K833921Agc Total Knee Prosthesis
Summary page 1
…cription: The AGC V2 Revision Knee System is an extension of Biomet’s knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The d…
Biomet, Inc.19842
*K912245Agc Revision Knee Prothesis
Summary page 1
…milies. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates wit…
Biomet, Inc.19913
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 1
…to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 sys…
Biomet, Inc.19926

Also cleared against K833921: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K094013HLS Kneetec SystemTornier20111

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?

  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K094013 (Tornier, 2011) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K833921.

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—

What is it indicated for?

Osteoarthritis, rheumatoid arthritis or traumatic arthritis

Failure of a previously failed joint replacement procedure

Correction of varus, valgus or post-traumatic deformity

Correction or revision of unsuccessful'osteotomy or arthrodesis

The device is intended for use with bone cement (Usa)

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 K833921

4 other devices cite the same predicate.

  • K094013HLS Kneetec SystemTornier · 2011
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System…Biomet, Inc. · 2004
  • K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  • K961021Kirschner Knee ModifiedBiomet, Inc. · 1997

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/K984054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984054: Agc V2 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/K984054

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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