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Whiteside Condylar II Total Knee Prosthesis

by Dow Corning Wright 510(k)

Active United States

510(k) K861715

Overview

The Whiteside Condylar II Total Knee Prosthesis is a femorotibial, non-constrained, cemented knee prosthesis made of metal and polymer components. It is classified as a total knee prosthesis under the Orthopedic specialty and was determined to be substantially equivalent to a legally marketed device.

This device is supplied as an implant for knee arthroplasty procedures and is intended for use in surgical settings. It is a reusable implant system composed of metal and polymer parts, with no indication of sterility, single-use designation, MRI safety, or specific storage conditions provided in the data. The device received FDA 510(k) clearance under K861715 on July 14, 1986, with product code HSX and regulation 888.3520.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861715 Date14 Jul 1986ClearedStatusActive

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
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  • 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
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Whiteside Condylar II Total Knee Prosthesis used for?

    It is used as an implant in knee arthroplasty procedures to replace damaged knee joint surfaces, specifically designed as a femorotibial, non-constrained, cemented prosthesis for total knee replacement surgery.

  • Is the Whiteside Condylar II Total Knee Prosthesis sterile or single-use?

    The device data does not indicate sterility or single-use designation; it is described as a reusable implant system composed of metal and polymer parts, though actual clinical use and sterility status would depend on manufacturer labeling and hospital reprocessing protocols.

  • What materials is the Whiteside Condylar II Total Knee Prosthesis made of?

    It is made of metal and polymer components, as specified in the device description, which classifies it as a femorotibial, non-constrained, cemented knee prosthesis.

  • How was the Whiteside Condylar II Total Knee Prosthesis cleared for market?

    It received FDA 510(k) clearance under K861715 on July 14, 1986, based on a determination of substantial equivalence to a legally marketed device, with product code HSX and regulation 888.3520.