Cleared Special

REVELATION POROUS HIP STEM (K994070) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K994070 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
49d
Days
Class 2
Risk

K994070 is an FDA 510(k) clearance for the REVELATION POROUS HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K994070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1999
Decision Date January 20, 2000
Days to Decision 49 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K994070.
POROCOAT PRODIGY HIP PROSTHESIS
K000207 · DePuy Orthopaedics, Inc. · Feb 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415 · DePuy Orthopaedics, Inc. · Feb 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · Exactech, Inc. · Jan 2000
MODULAR REACH HIP
K994038 · Biomet, Inc. · Dec 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849 · Howmedica Osteonics Corp. · Dec 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
K993082 · Exactech, Inc. · Nov 1999