Cleared Special

ATH FEMORAL STEM (K034028) - FDA 510(k) Clearance

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

K034028 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
73d
Days
Class 2
Risk

K034028 is an FDA 510(k) clearance for the ATH FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 11, 2004 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K034028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date March 11, 2004
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K034028.
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K050138 · Howmedica Osteonics Corp. · Mar 2005
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · DePuy Orthopaedics, Inc. · Dec 2004
IM TOTAL FEMUR
K033871 · Biomet, Inc. · Apr 2004
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K031730 · Howmedica Osteonics Corp. · Aug 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396 · Biomet, Inc. · Aug 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · Howmedica Osteonics Corp. · Aug 2003