Cleared Traditional

K953792 - CONSENSUS ZIRCONIA HEAD SIZE -3.5

K953792 is an FDA 510(k) clearance for CONSENSUS ZIRCONIA HEAD SIZE -3.5, manufactured by U.S. Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K953792 · U.S. Medical Products, Inc. · Orthopedic device
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Nov 1995
Decision
84d
Days
Class 2
Risk

K953792 is an FDA 510(k) clearance for the CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5. 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 November 6, 1995 after a review of 84 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 U.S. Medical Products, Inc. devices

FDA 510(k) Submission Details - K953792

510(k) Number K953792 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 14, 1995
Decision Date November 06, 1995
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K953792.
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · Biomet, Inc. · Jan 1996
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · Intermedics Orthopedics · Nov 1995
WAGNER REVISION STEM (MODIFICATION)
K953689 · Intermedics Orthopedics · Nov 1995
ZIRCONIA CERAMIC FEMORAL HEAD
K944689 · Wrightmedicaltechnologyinc · Oct 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · Biomet, Inc. · Sep 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169 · Stelkast Company · Aug 1995