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Dual Taper Wedge Pressed Fit Femoral Component

by Stelkast Company

510(k) K953268

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953268 Date17 Jan 1996ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1073-2009 FDA Unclassified (pre-2012) initiated 31 Oct 2008

    A possible breach of the sterile barrier packaging (Tyvek pouch).

    • Terminated Z-0664-2009 FDA Unclassified (pre-2012) initiated 7 Oct 2008

    Sterility may be compromised due to breach in packaging.

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  • Withdrawn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
LWJ
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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.

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum.

The Dual Taper Wedge Pressed Fit Femoral Component is a single use device intended for pressed fit reconstruction of the femoral portion of severely disabled and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, or avascular necrosis where radiographic evidence of sufficient bone stock exists. It is supplied sterile and has FDA 510(k) clearance K953268.

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