EVOLUTION Revision CCK System

by MicroPort Orthopedics Inc.

510(k) K171389

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K171389↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK171389	Date8 Aug 2017Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K171389
FDA product code: JWH
FDA applicant: Microport Orthopedics, Inc.

Device class: Class II
Regulation: 21 CFR Part 888.3560
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Evolution Revision CCK System is a revision knee prosthesis designed for partial or total knee arthroplasty, specifically addressing complex knee replacements requiring component exchange. It incorporates a constrained condylar knee (CCK) design to restore stability and function in revision scenarios, leveraging a medial-pivot mechanism for enhanced kinematic performance.

This system is intended for surgical use in orthopedic settings and is supplied as a sterile, single-use device. It is cleared by the FDA under 510(k) number K171389, with a product code of JWH, and is intended for use by trained orthopedic surgeons. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to implantation.

From the manufacturer

The Evolution ® revision knee system is built on a 20- year clinical heritage of patient satisfaction and survivorship. It is the only revision knee system that maintains the kinematic benefits of a medial-pivot design, while also offering surgeons intra-operative flexibility to meet all patient needs.

Source: microportortho.com

MicroPort Orthopedics revision knee systems are built on a 25-year clinical heritage of patient satisfaction and survivorship. The Evolution® revision system is the first revision knee system that maintains the proven kinematic benefits of a medial-pivot design, while also offering surgeons intra-operative flexibility to meet all patient needs.

Source: microportortho.com