Cleared Traditional

CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM (K933499) - FDA 510(k) Clearance

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

K933499 · U.S. Medical Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
303d
Days
Class 2
Risk

K933499 is an FDA 510(k) clearance for the CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by U.S. Medical Products, Inc. (Austin, US). The FDA issued a Cleared decision on May 18, 1994 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 U.S. Medical Products, Inc. devices

Submission Details

510(k) Number K933499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date May 18, 1994
Days to Decision 303 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
181d slower than avg
Panel avg: 122d · This submission: 303d
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 K933499.
SOLUTION HIP
K941942 · Depuy, Inc. · Jul 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · Depuy, Inc. · Jul 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · Exactech, Inc. · Jun 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · Biomet, Inc. · Mar 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395 · Depuy, Inc. · Mar 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519 · Osteonics Corp. · Mar 1994