Foundation Porous Hip Stem

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

510(k) Number

K973302 ↗

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 Foundation Porous Hip Stem used for?

  The Foundation Porous Hip Stem is a cementless femoral component used by orthopedic surgeons in total hip arthroplasty to replace diseased or fractured hips in clinical or surgical settings.

• How is the Foundation Porous Hip Stem supplied?

  The device is supplied as a single-use implant and features a wrought/forged Ti-6Al-4V stem with a porous coating of commercially pure titanium beads and includes a Morse taper for modular head attachment.

• What regulatory authorization does the Foundation Porous Hip Stem have?

  The Foundation Porous Hip Stem is authorized under FDA 510(k) clearance K973302, which determined it to be substantially equivalent to other predicate devices.

• Is the Foundation Porous Hip Stem available in different sizes or models?

  The device is available with or without a calcar collar, though specific sizes or models are not detailed in the provided information.