Cleared Traditional

DCW MODULAR PROXIMAL FEMORAL SYSTEM (K904028) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904028 · Dow Corning Wright · Orthopedic device
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Jan 1991
Decision
136d
Days
Class 2
Risk

K904028 is an FDA 510(k) clearance for the DCW MODULAR PROXIMAL FEMORAL SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dow Corning Wright devices

Submission Details

510(k) Number K904028 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 31, 1990
Decision Date January 14, 1991
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K904028.
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OSTEONICS PS HEAD AND NECK HIP STEM SERIES
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K894694 · Osteonics Corp. · Oct 1989
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K885102 · Osteonics Corp. · Jun 1989