510(k) Report

510(k) · Cleared

Cleared

Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System

K150544510(k) SpecialCleared May 29, 201587-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 Implant Systems, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 29, 2015 as substantially equivalent to K101281 (Aesculap Implant System, Inc., 2010) after an 87-day review. Its family tree reaches back 1 generation to 2010.

Decided
May 29, 2015
Review
87 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K101281 (2010). No later device cites it as a predicate yet.

K101281 · Vega Knee System · Aesculap Implant System, Inc. · 20102010201220142016
K101281 · Vega Knee System · Aesculap Implant System, Inc. · 20100
  1. Root · 1 generation backK101281 Vega Knee SystemAesculap Implant System, Inc. · 2010
  2. This deviceK150544 Columbus Total Knee System, Columbus Revision Knee System, EnduRo…Aesculap Implant Systems, LLC · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K101281Vega Knee SystemAesculap Implant System, Inc.2010—
0 (this device)K150544Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemAesculap Implant Systems, LLC2015—
FIG. 1 — Lineage of K150544, 2010–2015Source: 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? (1)

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
…Semi constrained Cemented Prosthesis SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, LLC believes allowing the use of the previously cleared VEGA patella (K101281) with Aesculap’s Columbus Total Knee System, Columbus Revision Knee System and EnduRo Knee System is a line extension that remain…
Aesculap Implant System, Inc.2010—

Also cleared against K101281: 4 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?

  • Its one ancestor has no recall.
  • 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?

Columbus Total Knee System, Columbus Revision Knee and EnduRo Knee System are 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…

Read the full statement (148 words)

Columbus Total Knee System, Columbus Revision Knee and EnduRo Knee System are 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.

Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

The Columbus Total Knee System, Columbus Revision Knee System and EnduRo Knee System are designed for use with bone cement.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K101281

4 other devices cite the same predicate.

  • K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants 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 Implant Systems, LLC

22 FDA decisions under this applicant name. See the company

  • K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC · 2022
  • K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
  • K180433Ennovate®Aesculap Implant Systems, LLC · 20181 recall
  • K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  • K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC · 2016

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/K150544 · printed Nov 4, 2026

Cite this page

510(k) Report. “K150544: Columbus Total Knee System, Columbus Revision Knee System, EnduRo 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/K150544

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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