510(k) Report

510(k) · Cleared

Cleared

VKS/TC-Plus Revision Knee

K032215510(k) SpecialCleared Aug 8, 200318-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

Plus Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Aug 8, 2003 as substantially equivalent to K022204 (Plus Orthopedics, 2002) and 1 other predicate after an 18-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it.

Decided
Aug 8, 2003
Review
18 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K923277 (1993). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 2 other ancestors2006: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant clearedK923277 · Foundation Knee System · Encore Orthopedics, Inc. · 1993 · recalledK000666 · TC-Plus Solution Knee · Plus Orthopedics · 2000 · recalledK022204 · VKS Knee System · Plus Orthopedics · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K022204 · VKS Knee System · Plus Orthopedics · 2002 · recalledK000666 · TC-Plus Solution Knee · Plus Orthopedics · 2000 · recalledK923277 · Foundation Knee System · Encore Orthopedics, Inc. · 1993 · recalled0
  1. Root · 3 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
  2. 2 generations backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
  3. 1 generation backK022204 VKS Knee SystemPlus Orthopedics · 2002 · Recalled
  4. This deviceK032215 VKS/TC-Plus Revision KneePlus Orthopedics · 2003
  5. Descendant · cites it directly · 5 of its ownK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · Recalled
  6. Descendant · 2 generations on · 4 of its ownK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
  7. Descendant · 2 generations on · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
  8. Descendant · 3 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
  9. Descendant · 4 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12012: 12015: 12019: 12021: 12025: 1
2006high 1 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · cites it directly5descendants
  • K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC · 2012 · 2 generations on4descendants
  • K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · 2 generations on3descendants
  • K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 3 generations on2descendants
  • K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K923277Foundation Knee SystemEncore Orthopedics, Inc.19934
−2K000666TC-Plus Solution KneePlus Orthopedics20009
−1K022204VKS Knee SystemPlus Orthopedics20024
0 (this device)K032215VKS/TC-Plus Revision KneePlus Orthopedics2003—
+1K053390Columbus (CR) Total Knee SystemAesculap, Inc.20061
+2K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC2012—
+2K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC2015—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.2019—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201210
201510
201910
202110
202510
FIG. 1 — Lineage of K032215, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K022204VKS Knee System
Summary page 1
…ial, semi-constrained, cemented, polymer/metaVpolymer (per 21 CFR section 888.3560) Equivalent Device The VKS/TC-PLUS Revision Knee is equivalent to the VKS Total Knee (K022204) in terms of materials, articulating surface geometry, constraint and indications, and the RT-PLUS Modular Knee (K023667) in term…
Plus Orthopedics20024
*K023667RT-Plus Solution & RT-Plus Modular Solution Knee
Summary page 1
…vision Knee is equivalent to the VKS Total Knee (K022204) in terms of materials, articulating surface geometry, constraint and indications, and the RT-PLUS Modular Knee (K023667) in terms of modular stems and augmentation blocks. Device Description The VKS/TC-PLUS Revision Knee is a tri-compartmental knee…
Plus Orthopedics2002—

Also cleared against K022204: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K053390Columbus (CR) Total Knee SystemAesculap, Inc.20065

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?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K053390 (Aesculap, Inc., 2006) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K022204.

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?

VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision knee arthroplasty where the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, or connective tissue disorders. It is for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K022204

4 other devices cite the same predicate.

  • K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc. · 2012
  • K072858TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 200715 recalls
  • K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc. · 2006
  • K023416Modification to VKS Knee SystemPlus Orthopedics · 2002

More from Plus Orthopedics

38 FDA decisions under this applicant name. See the company

  • K032126Promos ShoulderPlus Orthopedics · 2004
  • K033763Modification to Slim Gliding Nail SystemPlus Orthopedics · 2003
  • K032709Modular Plus Hip StemPlus Orthopedics · 2003
  • K032548IP-XS Compression Nail SystemPlus Orthopedics · 2003
  • K032052UC-Plus Solution Unicondylar KneePlus Orthopedics · 20031 recall

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/K032215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032215: VKS/TC-Plus Revision Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032215

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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