Revelation Porous Hip Stem

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

510(k) Number

K973685 ↗

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 Revelation Porous Hip Stem used for?

  The Revelation Porous Hip Stem is a cementless, collarless femoral component designed for total hip arthroplasty. It treats patients with degenerative joint diseases including osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity correction, and revision procedures where other treatments have failed.

• Is the Revelation Porous Hip Stem reusable or single-use?

  The Revelation Porous Hip Stem is supplied as a single-use device. It should not be reused on multiple patients as this could compromise sterility and device performance, potentially leading to surgical complications or device failure.

• What materials is the Revelation Porous Hip Stem made from?

  The Revelation Porous Hip Stem is fabricated from Ti-6Al-4V alloy with a porous surface. This material provides excellent biocompatibility and osseointegration properties, allowing for bone ingrowth and long-term stability in the femoral canal.

• What regulatory approvals does the Revelation Porous Hip Stem have?

  The Revelation Porous Hip Stem has FDA 510(k) clearance with product code LPH. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway, with the Orthopedic advisory committee reviewing the submission.