510(k) Report

510(k) · Cleared

Cleared

VEGA Knee System, Columbus Total Knee System

K143443510(k) SpecialCleared Mar 25, 2015113-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 Implants Systems, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 25, 2015 as substantially equivalent to K101281 (Aesculap Implant System, Inc., 2010) and 10 other predicates after a 113-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.

Decided
Mar 25, 2015
Review
113 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
11

Its longest line of descent runs back 7 generations to K915192 (1992). 62 ancestors in all, the oldest K853661 (1985). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2013: 1 other ancestor2012: 1 other ancestor2010: 1 other ancestor2007: 5 other ancestors2006: 2 other ancestors2002: 6 other ancestors2005: 4 other ancestors2003: 7 other ancestors2000: 2 other ancestors1998: 2 other ancestors1996: 6 other ancestors1985: 1 other ancestor2004: 3 other ancestors2001: 3 other ancestors1997: 3 other ancestors1995: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1993: 2 other ancestors1992: 1 other ancestor2019: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant clearedReference device: K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK915192 · 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) K083772 · Columbus Revision Knee System · Aesculap Implant System, Inc. · 2009 · recalledK101815 · Enduro Knee System · Aesculap Implant Systems · 2010K120955 · Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System · Aesculap Implant Systems, LLC · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 17 other ancestors3 generations back: 20 other ancestors4 generations back: 8 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants K120955 · Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System · Aesculap Implant Systems, LLC · 2012K101815 · Enduro Knee System · Aesculap Implant Systems · 2010K083772 · Columbus Revision Knee System · Aesculap Implant System, Inc. · 2009 · recalledK022672 · 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. · 1992−50
  1. Root · 7 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
  2. 6 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
  3. 5 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
  4. 4 generations backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
  5. 3 generations backK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · Recalled
  6. 2 generations backK101815 Enduro Knee SystemAesculap Implant Systems · 2010
  7. 1 generation backK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
  8. This deviceK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
  9. Descendant · cites it directly · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
  10. Descendant · 2 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  11. Descendant · 2 generations on · 0 of its ownK201611 Apex Knee SystemOmnilife Science · 2021

Most influential descendants

Showing 3 of 3 · See all
  • K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · cites it directly2descendants
  • K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on0descendants
  • K201611Apex Knee SystemOmnilife Science · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K9151927000 Series Modular Tibial ComponentsOsteonics Corp.1992—
−6K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.20008
−5K021313Search Evolution Total Knee SystemAesculap, Inc.2002—
−4K022672Columbus Total Knee System (CR)Aesculap, Inc.20021
−3K083772Columbus Revision Knee SystemAesculap Implant System, Inc.20094
−2K101815Enduro Knee SystemAesculap Implant Systems2010—
−1K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC2012—
0 (this device)K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC2015—
+1K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.2019—
+2K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+2K201611Apex Knee SystemOmnilife Science2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199110
199210
199320
199410
199510
199660
199730
199820
200020
200130
200260
200370
200430
200540
200620
200750
201010
201210
201310
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202110
202510
FIG. 1 — Lineage of K143443, 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? (11)

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
*K101281Vega Knee System
Summary page 4
…bia posterior stabilizing and cruciate retaining implants with an optional centralizer are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathl…
Aesculap Implant System, Inc.2010—
*K121879Vega Knee System
Summary page 4
…rior stabilizing and cruciate retaining implants with an optional centralizer are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-P…
Aesculap Implant Systems2012—
*K140452Vega Knee System
Summary page 4
…ilizing and cruciate retaining implants with an optional centralizer are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethyle…
Aesculap Implant Systems2014—
*K143106VEGA Knee System
Summary page 4
…ruciate retaining implants with an optional centralizer are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Imp…
Aesculap Implant Systems, LLC2014—
*K022672Columbus Total Knee System (CR)
Summary page 4
…ional centralizer are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Implants (K123166). DEVICE DESCRIPTION…
Aesculap, Inc.20021
*K023788Columbus (CR) Total Knee System
Summary page 4
…tralizer are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Implants (K123166). DEVICE DESCRIPTION All Poly…
Aesculap, Inc.2002—
*K053390Columbus (CR) Total Knee System
Summary page 4
…are substantially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Implants (K123166). DEVICE DESCRIPTION All Poly Tibia pos…
Aesculap, Inc.20061
*K071220Columbus Total Knee System as
Summary page 4
…antially equivalent to the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Implants (K123166). DEVICE DESCRIPTION All Poly Tibia posterior st…
Aesculap Implant Systems, Inc.20071
*K071499Columbus Total Knee System Mios CR/PS Tibial Tray
Our reading of the summary gave K071449, FDA’s number for BRM3 Brain Monitor (Brainz Instruments, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Columbus Total Knee System”.
Aesculap Implant Systems, Inc.2007—
*K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System
Summary page 4
…o the currently marketed Aesculap VEGA Knee System® (K101281, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Implants (K123166). DEVICE DESCRIPTION All Poly Tibia posterior stabilizing and cruciat…
Aesculap Implant Systems, LLC2012—
*K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…
Summary page 4
…81, K121879, K140452, and K143106), Columbus Total Knee System (K022672; K023788; K053390; K071220; K071449 and K120955) and Triathlon® All-Polyethylene Tibial Implants (K123166). DEVICE DESCRIPTION All Poly Tibia posterior stabilizing and cruciate retaining implants are a line extension to the VEGA Knee…
Howmedica Osteonics Corp.2013—
†K042344Excia Total Hip SystemAesculap, Inc.200510

Also cleared against K101281: 4 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192

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 23 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
  • 29 of the 62 ancestors have a recall of any class.
  • Of its descendants, K191765 (Omni Life Science, Inc., 2019) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K101281.

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. 2015, this device’s year, is highlighted.

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 VEGA 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. Posterior Stabilized (PS) components are also for absent or non-functioning posterior…

Read the full statement (163 words)

The VEGA 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.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee is designed for use with bone cement.

The Columbus 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.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The Columbus Knee is designed for use with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K101281

4 other devices cite the same predicate.

  • K150544Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemAesculap Implant Systems, LLC · 2015
  • K143106VEGA Knee SystemAesculap Implant Systems, LLC · 2014
  • K140452Vega Knee SystemAesculap Implant Systems · 2014
  • K121879Vega Knee SystemAesculap Implant Systems · 2012

More from Aesculap Implants Systems, LLC

3 FDA decisions under this applicant name. See the company

  • K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC · 2023
  • K172235CoreHip® SystemAesculap Implants Systems, LLC · 2018

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/K143443 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143443: VEGA Knee System, Columbus Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143443

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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