Skip to content

Revelation Porous Hip Stem

by Encore Orthopedics, Inc. 2 variants

510(k) K994070

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Special NumberK994070 Date20 Jan 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Revelation Porous Hip Stem is an orthopedic device intended for hip joint replacement. It is a femoral stem component designed to be implanted in the femur to support a hip prosthesis.

This device is supplied sterile and is intended for single-use. It received FDA 510(k) clearance (K994070) as substantially equivalent to a predicate device, with special clearance type and review by the Orthopedic advisory committee.

Other devices from Encore Orthopedics, Inc.

See all devices from Encore Orthopedics, Inc. →