Cleared Special

CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 (K030265) - FDA 510(k) Clearance

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

K030265 · Zimmer, Inc. · Orthopedic device
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Mar 2003
Decision
36d
Days
Class 2
Risk

K030265 is an FDA 510(k) clearance for the CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 36 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 Zimmer, Inc. devices

Submission Details

510(k) Number K030265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date March 04, 2003
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 K030265.
OXINIUM FEMORAL HEADS
K030766 · Smith & Nephew, Inc. · Jul 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · Biomet, Inc. · Jul 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · Zimmer, Inc. · Apr 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · Smith & Nephew, Inc. · Feb 2003
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · Howmedica Osteonics Corp. · Nov 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · DePuy Orthopaedics, Inc. · Nov 2002