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Evolution Mp Adaptive Cs Insert

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K113325

Overview

The Evolution Mp Adaptive Cs Insert is a prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer device. It is used in knee arthroplasty in skeletally mature patients with noninflammatory degenerative joint disease, including osteoarthritis, traumatic arthritis, or avascular necrosis.

The device is supplied with a product code of JWH and is classified as a Class II device with special controls. It has received FDA 510K clearance, with the clearance type being special and the decision description being substantially equivalent. The device is associated with the k number K113325.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK113325 Date9 Dec 2011ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Evolution Mp Adaptive Cs Insert used for?

    The Evolution Mp Adaptive Cs Insert is used in knee arthroplasty for skeletally mature patients with noninflammatory degenerative joint disease, including osteoarthritis, traumatic arthritis, or avascular necrosis.

  • How is the device supplied?

    The device is supplied with a product code of JWH and is classified as a Class II device with special controls.

  • What is the regulatory status of the device?

    The device has received FDA 510K clearance, with the clearance type being special and the decision description being substantially equivalent, associated with the k number K113325.

  • What type of material is the device made of?

    The device is made of a combination of polymer, metal, and polymer materials.