Foundation Porous Coated Flared Rim Shell

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

510(k) Number

K974095 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

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 Porous Coated Flared Rim Shell?

  This device is a metal-backed acetabular component designed for use in total hip arthroplasty. It serves to replace the natural acetabulum in patients suffering from conditions such as arthritis, necrosis, or fracture.

• What size options are available for this acetabular shell?

  The Foundation Porous Coated Flared Rim Shell is manufactured in a range of sizes from 44mm to 70mm to accommodate different patient anatomies during hip replacement surgery.

• Are there different configurations for the shell regarding fixation?

  Yes, the device is available in versions both with and without screw holes, allowing orthopedic surgeons to select the configuration that best suits the clinical requirements of the procedure.

• What is the regulatory status of this device?

  The Foundation Porous Coated Flared Rim Shell has received FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.