Cleared Special

EVOLVE CERAMIC RADIAL HEAD IMPLANT (K030384) - FDA 510(k) Clearance

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

K030384 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
188d
Days
Class 2
Risk

K030384 is an FDA 510(k) clearance for the EVOLVE CERAMIC RADIAL HEAD IMPLANT. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 12, 2003 after a review of 188 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K030384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2003
Decision Date August 12, 2003
Days to Decision 188 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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 - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 15
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K030384.
EVOLVE MODULAR RADIAL HEAD
K060731 · Wrightmedicaltechnologyinc · Apr 2006
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · Biomet, Inc. · Aug 2005
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · Biomet, Inc. · Jun 2004
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · Biomet, Inc. · Jan 2002
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · Howmedica Osteonics Corp. · Jul 2000
ERS RADIAL HEAD REPLACEMENT
K000658 · DePuy Orthopaedics, Inc. · May 2000