Cleared Traditional

K904028 - DCW MODULAR PROXIMAL FEMORAL SYSTEM

K904028 is an FDA 510(k) clearance for DCW MODULAR PROXIMAL FEMORAL SYSTEM, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 136-day FDA review.

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

FDA 510(k) Submission Details - K904028

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
Combination Product No
PCCP Authorized No
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.

LZO Device Classification - Class 2, Special Controls

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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K904028.
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · Biomet, Inc. · Apr 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · Zimmer, Inc. · Mar 1991
TOTAL HIP FEMORAL COMPONENT
K905260 · Intermedics Orthopedics · Jan 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976 · Kinamed, Inc. · Jan 1991
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · Osteonics Corp. · Aug 1990
KINAMED CEMENTED ATH-LONG STEM
K902073 · Kinamed, Inc. · Jun 1990