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Kim Modular Femoral Hip Prosthesis

by Dow Corning Wright 510(k)

Active United States

510(k) K895399

Overview

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device is classified under product code LZO as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented.

The Kim Modular Femoral Hip Prosthesis received FDA 510(k) clearance K895399 on December 14, 1989, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Dow Corning Wright. The device is supplied for orthopedic use in hip joint replacement procedures.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895399 Date14 Dec 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Dow Corning Wright

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Questions

  • What is the Kim Modular Femoral Hip Prosthesis used for?

    It is intended to replace a hip joint in orthopedic procedures, designed as a semi-constrained prosthesis made of metal, ceramic, and polymer materials for implantation in hip joint replacement surgeries.

  • How is the Kim Modular Femoral Hip Prosthesis supplied and implanted?

    The device is supplied for orthopedic use in hip joint replacement procedures and can be implanted either with cement or as a nonporous uncemented prosthesis, depending on surgical technique and patient anatomy.

  • What regulatory pathway was used for the Kim Modular Femoral Hip Prosthesis?

    It received FDA 510(k) clearance under number K895399 on December 14, 1989, following a traditional review process and was determined to be substantially equivalent to a predicate device.