510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Columbus (CR) Total Knee System

K053390510(k) SpecialCleared Feb 6, 200663-day reviewClass II21 CFR 888.3560Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 6, 2006 as substantially equivalent to K022672 (Aesculap, Inc., 2002) and 4 other predicates after a 63-day review. Its family tree reaches back 4 generations to 1992. 5 later devices descend from it. It has been recalled once.

Decided
Feb 6, 2006
Review
63 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
5

Its longest line of descent runs back 4 generations to K915192 (1992). 26 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 2 other ancestors2002: 2 other ancestors2004: 1 other ancestor2001: 3 other ancestors2000: 2 other ancestors1998: 2 other ancestors1997: 1 other ancestor1996: 4 other ancestors1995: 1 other ancestor1993: 2 other ancestors1992: 1 other ancestor2012: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant clearedK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 1992K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalled×2: 2 generations cleared close together, K021313 (2002), K022672 (2002) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 10 other ancestors3 generations back: 3 other ancestors4 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants K022672 · Columbus Total Knee System (CR) · Aesculap, Inc. · 2002 · recalledK021313 · Search Evolution Total Knee System · Aesculap, Inc. · 2002K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalledK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 19920
  1. Root · 4 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
  2. 3 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
  3. 2 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
  4. 1 generation backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
  5. This deviceK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006
  6. Descendant · cites it directly · 4 of its ownK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
  7. Descendant · cites it directly · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
  8. Descendant · 2 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
  9. Descendant · 3 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  10. Descendant · 3 generations on · 0 of its ownK201611 Apex Knee SystemOmnilife Science · 2021

Most influential descendants

Showing 5 of 5 · See all
  • K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC · 2012 · cites it directly4descendants
  • K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · cites it directly3descendants
  • K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
  • K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on0descendants
  • K201611Apex Knee SystemOmnilife Science · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K9151927000 Series Modular Tibial ComponentsOsteonics Corp.1992—
−3K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.20008
−2K021313Search Evolution Total Knee SystemAesculap, Inc.2002—
−1K022672Columbus Total Knee System (CR)Aesculap, Inc.20021
0 (this device)K053390Columbus (CR) Total Knee SystemAesculap, Inc.2006—
+1K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC2012—
+1K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC2015—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.2019—
+3K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+3K201611Apex Knee SystemOmnilife Science2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199320
199510
199640
199710
199820
200020
200130
200220
200320
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201910
202110
202510
FIG. 1 — Lineage of K053390, 1992–2025Source: 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? (5)

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
*K022672Columbus Total Knee System (CR)
Summary page 1
…SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Columbus (CR)Total Knee System additions are substvntially equivalent to Aesculap's ColuMbus Total Knee System (K022672), Smith & Nephew's revision knee system (K043440) and PLUS Orthopedic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT…
Aesculap, Inc.20021
*K043440Smith & Nephew, Inc. Revision Knee System
Summary page 1
…that the Columbus (CR)Total Knee System additions are substvntially equivalent to Aesculap's ColuMbus Total Knee System (K022672), Smith & Nephew's revision knee system (K043440) and PLUS Orthopedic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667)…
Smith & Nephew, Inc.20057
*K032215VKS/TC-Plus Revision Knee
Summary page 1
…tvntially equivalent to Aesculap's ColuMbus Total Knee System (K022672), Smith & Nephew's revision knee system (K043440) and PLUS Orthopedic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667), and Howmedica Osteonics's Tibial Tray Screw Hole Plugs (…
Plus Orthopedics2003—
*K023667RT-Plus Solution & RT-Plus Modular Solution Knee
Summary page 1
…, Smith & Nephew's revision knee system (K043440) and PLUS Orthopedic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667), and Howmedica Osteonics's Tibial Tray Screw Hole Plugs (K032479). DEVICE DESCRIPTION The cemented Columbus (CR)Total Knee Syst…
Plus Orthopedics2002—
*K032479Howmedica Osteonics Tibial Tray Screw Hole Plugs
Summary page 1
…dic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667), and Howmedica Osteonics's Tibial Tray Screw Hole Plugs (K032479). DEVICE DESCRIPTION The cemented Columbus (CR)Total Knee System additions include a CRA/PSA tibial tray and hemispacers, common…
Howmedica Osteonics Corp.2003—

Also cleared against K022672: 6 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124
K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 21, 2020Class IIZ-1480-2020Material/Component ContaminationLow Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • 13 of the 26 ancestors have a recall of any class.
  • Of its descendants, K120955 (Aesculap Implant Systems, LLC, 2012) has gone furthest, with 4 descendants of its own.
  • 6 other devices also cite its predicate K022672.

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?

The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee (CR) is designed for use with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K022672

6 other devices cite the same predicate.

  • K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
  • K083772Columbus Revision Knee SystemAesculap Implant System, Inc. · 20094 recalls
  • K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007
  • K071220Columbus Total Knee System asAesculap Implant Systems, Inc. · 20071 recall
  • K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc. · 2006
  • K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

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  • K223596SQ.line KERRISONAesculap, Inc. · 2023
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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/K053390 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053390: Columbus (CR) 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/K053390

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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