Cleared Traditional

HOWMEDICA ALUMINA FEMORAL HEAD (K915184) - FDA 510(k) Clearance

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

K915184 · Pfizer Hospital Products Group, Inc. · Orthopedic device
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Jan 1992
Decision
74d
Days
Class 2
Risk

K915184 is an FDA 510(k) clearance for the HOWMEDICA ALUMINA FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Pfizer Hospital Products Group, Inc. (Rutherford, US). The FDA issued a Cleared decision on January 31, 1992 after a review of 74 days - a notably fast clearance cycle.

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: 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 Pfizer Hospital Products Group, Inc. devices

Submission Details

510(k) Number K915184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date January 31, 1992
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
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 K915184.
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · Biomet, Inc. · Nov 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K915396 · Osteonics Corp. · Oct 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
K920577 · Howmedica Corp. · May 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · Biomet, Inc. · Jan 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574 · Exactech, Inc. · Jan 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · Zimmer, Inc. · Jan 1992