Cleared Traditional

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (K954768) - FDA 510(k) Clearance

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

K954768 · Biologically Oriented Prostheses · Orthopedic device
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Jan 1996
Decision
93d
Days
Class 2
Risk

K954768 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 January 18, 1996 after a review of 93 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Biologically Oriented Prostheses devices

Submission Details

510(k) Number K954768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date January 18, 1996
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
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 K954768.
P.F.C. CERAMIC HIP HEAD
K962248 · Johnson & Johnson Professionals, Inc. · Aug 1996
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