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Columbus Total Knee System (CR)

by Aesculap, Inc.

510(k) K022672

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022672 Date8 Nov 2002ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1478-2020 FDA Class II initiated 21 Jan 2020

    Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

Timeline

2 dated events

  1. Cleared FDA 510(k) K022672
  2. Recall initiated FDA recalls Z-1478-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JWH
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Columbus Total Knee System (CR) is a knee prosthesis designed for bicondylar indications. It is an anatomically-designed system that provides options for knee arthroplasty.

This system allows for intraoperative flexibility, including the ability to change from a PCL-retaining treatment to a PCL-sacrificing treatment. The device is authorized via FDA 510k clearance.

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