510(k) Report

510(k) · Cleared

Cleared

Howmedica Kinemax Plus Total Knee System

K910500510(k) TraditionalCleared May 6, 199190-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

Howmedica Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 6, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.

Decided
May 6, 1991
Review
90 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

50 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2011: 1 descendant cleared1996: 1 descendant cleared2000: 1 descendant cleared2020: 5 descendants cleared2024: 2 descendants cleared2015: 3 descendants cleared2016: 2 descendants cleared2023: 12 descendants cleared2021: 6 descendants cleared2019: 3 descendants cleared2025: 4 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2022: 4 descendants cleared2026: 3 descendants cleared1990200020102020
  1. This deviceK910500 Howmedica Kinemax Plus Total Knee SystemHowmedica Corp. · 1991
  2. Descendant · cites it directly · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
  3. Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
  4. Descendant · 2 generations on · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
  5. Descendant · 2 generations on · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
  6. Descendant · 2 generations on · 24 of its ownK150105 Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1996: 12000: 12011: 12012: 12014: 12015: 32016: 22018: 12019: 32020: 52021: 62022: 42023: 122024: 22025: 42026: 3
1996high 12 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 50 · See all
  • K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · cites it directly33descendants
  • K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants
  • K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 2 generations on24descendants
  • K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 2 generations on24descendants
  • K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910500Howmedica Kinemax Plus Total Knee SystemHowmedica Corp.1991—
+1K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.2012—
+2K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.2014—
+2K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.2015—
+2K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.2015—
+2K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
201110
201210
201410
201530
201620
201810
201930
202050
202160
202240
2023120
202420
202540
202630
FIG. 1 — Lineage of K910500, 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? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233
K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117
K994207Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp.20006
K963796Kinemax Plus Modular Stabilizer Femoral Component and Femoral SpacersHowmedica Corp.19960

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?

  • Of its descendants, K112906 (Total Joint Orthopedics, Inc., 2012) has gone furthest, with 33 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 Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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/K910500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910500: Howmedica Kinemax Plus Total 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/K910500

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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