Cleared Special

K031730 - 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS

K031730 is an FDA 510(k) clearance for 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 86-day FDA review.

K031730 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
86d
Days
Class 2
Risk

K031730 is an FDA 510(k) clearance for the 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 86 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.

FDA 510(k) Submission Details - K031730

510(k) Number K031730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2003
Decision Date August 29, 2003
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

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 564
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K031730.
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K031744 · Howmedica Osteonics Corp. · Aug 2003
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K030766 · Smith & Nephew, Inc. · Jul 2003
K031730 · 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
Download PDF FDA Summary Howmedica Osteonics C…