510(k) Report

510(k) · Cleared

Cleared

Columbus Ultra Congruent (UC) Tibial Insert/Gliding Surface

K053579510(k) SpecialCleared May 17, 2006146-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

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

Cleared on May 17, 2006 as substantially equivalent to K022672 (Aesculap, Inc., 2002) and 2 other predicates after a 146-day review. Its family tree reaches back 4 generations to 1992.

Decided
May 17, 2006
Review
146 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K915192 (1992). 16 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2000: 2 other ancestors1998: 2 other ancestors2001: 1 other ancestor1996: 2 other ancestors1993: 2 other ancestors1992: 1 other ancestorK915192 · 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. · 2002K022672 · Columbus Total Knee System (CR) · Aesculap, Inc. · 2002 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors 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 deviceK053579 Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc. · 2006
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)K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199320
199620
199820
200020
200110
200220
FIG. 1 — Lineage of K053579, 1992–2006Source: 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
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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
*K022672Columbus Total Knee System (CR)
Summary page 1
…the Columbus Total Knee System is a line extension of the standard and deep dish tibial inserts that were cleared as components of Aesculap's Columbus Total Knee System (K022672 and K023788). It is also substantially equivalent to the ultra congruent inserts that were cleared for the VKS Knee System (K0222…
Aesculap, Inc.20021
*K023788Columbus (CR) Total Knee System
Summary page 1
…Total Knee System is a line extension of the standard and deep dish tibial inserts that were cleared as components of Aesculap's Columbus Total Knee System (K022672 and K023788). It is also substantially equivalent to the ultra congruent inserts that were cleared for the VKS Knee System (K022204). DEVICE…
Aesculap, Inc.2002—
*K022204VKS Knee System
Summary page 1
…esculap's Columbus Total Knee System (K022672 and K023788). It is also substantially equivalent to the ultra congruent inserts that were cleared for the VKS Knee System (K022204). DEVICE DESCRIPTION The Ultra Congruent Tibial Insert is a gliding surface for the Columbus Total Knee System made from UHMWPE.…
Plus Orthopedics20024

Also cleared against K022672: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 9 of the 16 ancestors have a recall of any class.
  • 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
  • K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 20061 recall
  • 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

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • 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/K053579 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053579: Columbus Ultra Congruent (UC) Tibial Insert/Gliding Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053579

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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