510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Columbus Total Knee System (CR)

K022672510(k) TraditionalCleared Nov 8, 200288-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 Nov 8, 2002 as substantially equivalent to K021313 (Aesculap, Inc., 2002) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1992. 96 later devices descend from it. It has been recalled once.

Decided
Nov 8, 2002
Review
88 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
3

Its longest line of descent runs back 3 generations to K915192 (1992). 11 ancestors in all. 96 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 2 other ancestors2001: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2004: 1 descendant cleared2009: 3 descendants cleared2007: 3 descendants cleared2006: 2 descendants cleared2015: 2 descendants cleared2012: 10 descendants cleared2008: 2 descendants cleared2010: 3 descendants cleared2019: 2 descendants cleared2013: 8 descendants cleared2021: 10 descendants cleared2025: 10 descendants cleared2011: 5 descendants cleared2014: 3 descendants cleared2017: 3 descendants cleared2016: 1 descendant cleared2022: 4 descendants cleared2020: 5 descendants cleared2024: 2 descendants cleared2026: 9 descendants cleared2023: 5 descendants cleared2018: 3 descendants clearedK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 1992K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalledK021313 · Search Evolution Total Knee System · Aesculap, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 12 descendants5 generations forward: 21 descendants6 generations forward: 26 descendants7 generations forward: 13 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants K021313 · 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+5
  1. Root · 3 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
  2. 2 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
  3. 1 generation backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
  4. This deviceK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002
  5. Descendant · cites it directly · 80 of its ownK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
  6. Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  7. Descendant · 3 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
  8. Descendant · 4 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
  9. Descendant · 5 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22007: 32008: 22009: 32010: 32011: 52012: 102013: 82014: 32015: 22016: 12017: 32018: 32019: 22020: 52021: 102022: 42023: 52024: 22025: 102026: 9
2004high 10 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 96 · See all
  • K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004 · cites it directly80descendants
  • K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
  • K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 3 generations on78descendants
  • K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 4 generations on52descendants
  • K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 5 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K9151927000 Series Modular Tibial ComponentsOsteonics Corp.1992—
−2K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.20008
−1K021313Search Evolution Total Knee SystemAesculap, Inc.2002—
0 (this device)K022672Columbus Total Knee System (CR)Aesculap, Inc.2002—
+1K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.2004—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
+3K081023Evolis Total Knee SystemMedacta International S.A.20081
+4K090988GMK Total Knee SystemMedacta International S.A.20091
+5K102437GMK Revision Knee SystemMedacta International S.A.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199620
199820
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200730
200820
200930
201030
201150
2012100
201380
201430
201520
201610
201730
201830
201920
202050
2021100
202240
202350
202420
2025100
202690
FIG. 1 — Lineage of K022672, 1992–2026Source: 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), 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
*K021313Search Evolution Total Knee System
Summary page 2
…NTIAL EQUIVALENCE Aesculap@', Inc. believes that the Columbus Total Knee System is substantially equivalent to: 0 Search Evolution Total Knee System (K021313) Scorpio Posterior Cruciate Retaining Knee System (K974556) 0 Gem Knee System (K994214)…
Aesculap, Inc.2002—
*K974556Osteonics Scorpio Posterior Cruciate Retaining Total Knee System
Summary page 2
…otal Knee System is substantially equivalent to: 0 Search Evolution Total Knee System (K021313) Scorpio Posterior Cruciate Retaining Knee System (K974556) 0 Gem Knee System (K994214) 0005 (3 *.h, DEPARTME…
Osteonics Corp.19987
*K994214Gem Knee System
Summary page 2
…uivalent to: 0 Search Evolution Total Knee System (K021313) Scorpio Posterior Cruciate Retaining Knee System (K974556) 0 Gem Knee System (K994214) 0005 (3 *.h, DEPARTMENT OF HEALTH & HUMAN SERVICES…
Kinamed, Inc.2000—

Also cleared against K021313: 4 other devices →

What descends from it? (96)

See all 96

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

NumberDeviceApplicantDecidedDescendants
K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.200480
K083772Columbus Revision Knee SystemAesculap Implant System, Inc.200912
K071220Columbus Total Knee System asAesculap Implant Systems, Inc.20077
K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076
K053390Columbus (CR) Total Knee SystemAesculap, Inc.20065
K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153
K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 21, 2020Class IIZ-1478-2020Material/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 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
  • 5 of the 11 ancestors have a recall of any class.
  • Of its descendants, K032108 (Aesculap, Inc., 2004) has gone furthest, with 80 descendants of its own.
  • 4 other devices also cite its predicate K021313.

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 Total Knee System (CR) 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 to for use with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K021313

4 other devices cite the same predicate.

  • K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  • K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
  • K030367Columbus (PS)Aesculap, Inc. · 20031 recall
  • K023788Columbus (CR) Total Knee SystemAesculap, Inc. · 2002

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
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  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, 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/K022672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022672: Columbus Total Knee System (CR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022672

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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