Cleared Traditional

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (K953045) - FDA 510(k) Clearance

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

K953045 · Biologically Oriented Prostheses · Orthopedic device
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Sep 1995
Decision
89d
Days
Class 2
Risk

K953045 is an FDA 510(k) clearance for the BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Biologically Oriented Prostheses (Port Huron, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 89 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 Biologically Oriented Prostheses devices

Submission Details

510(k) Number K953045 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 30, 1995
Decision Date September 27, 1995
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 K953045.
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · Biomet, Inc. · Jan 1996
ZIRCONIA CERAMIC FEMORAL HEAD
K944689 · Wrightmedicaltechnologyinc · Oct 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · Biomet, Inc. · Sep 1995
V40 ZIRCONIA FEMORAL HEADS
K952418 · Howmedica Corp. · Jul 1995
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
K952088 · Depuy, Inc. · Jun 1995