Cleared Traditional

MULLER-TYPE FEMORAL COMPONENT (K903243) - FDA 510(k) Clearance

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

K903243 · Onyx Medical Corp. · Orthopedic device
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Jul 1990
Decision
6d
Days
Class 2
Risk

K903243 is an FDA 510(k) clearance for the MULLER-TYPE FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Onyx Medical Corp. (Memphis, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 6 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Onyx Medical Corp. devices

Submission Details

510(k) Number K903243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date July 30, 1990
Days to Decision 6 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 122d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K903243.
HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE
K902436 · Zimmer, Inc. · Aug 1990
MODIFIED AML + ACETABULAR CUP SYSTEM
K902395 · Depuy, Inc. · Aug 1990
MODIFIED DEPUY ACETABULAR CUP SYSTEM
K902396 · Depuy, Inc. · Aug 1990
HGP II TOTAL HIP FEMERAL STEM
K901364 · Zimmer, Inc. · May 1990
MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
K901087 · Depuy, Inc. · May 1990
MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
K900832 · Depuy, Inc. · May 1990