Foundation Non-Porous Stem

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

510(k) Number

K935449 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What is the intended use of the Foundation Non-Porous Stem?

  This device is designed to function as a cemented total hip replacement component. It is classified as a semi-constrained hip prosthesis, meaning it is intended to provide stability and support within the hip joint during total hip arthroplasty.

• What materials are used in the construction of this hip prosthesis?

  The Foundation Non-Porous Stem is manufactured as a metal and polymer semi-constrained cemented prosthesis. These materials are selected to provide the necessary structural integrity and articulation required for a cemented total hip replacement.

• How is this device identified for regulatory purposes?

  The Foundation Non-Porous Stem is identified under FDA 510(k) number K935449. This regulatory filing, submitted by Encore Orthopedics, Inc., indicates that the device was determined to be substantially equivalent to existing legally marketed devices.