Cleared Traditional

MECTACER BIOLOX FORTE-FEMORAL HEADS (K073337) - FDA 510(k) Clearance

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

K073337 · Medacta International S.A. · Orthopedic device
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Feb 2008
Decision
77d
Days
Class 2
Risk

K073337 is an FDA 510(k) clearance for the MECTACER BIOLOX FORTE-FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Medacta International S.A. (San Diego, US). The FDA issued a Cleared decision on February 13, 2008 after a review of 77 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 Medacta International S.A. devices

Submission Details

510(k) Number K073337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2007
Decision Date February 13, 2008
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 287
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K073337.
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
K081860 · Zimmer, Inc. · Sep 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
K072852 · Smith & Nephew, Inc. · Jun 2008
DEPUY TRI-LOCK BONE PRESERVATION STEM
K073570 · DePuy Orthopaedics, Inc. · Feb 2008
DYNASTY CERAMIC FEMORAL HEAD
K072656 · Wrightmedicaltechnologyinc · Feb 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
K071535 · Zimmer, Inc. · Nov 2007
DEPUY DELTA TS CERAMIC FEMORAL HEADS
K071830 · DePuy Orthopaedics, Inc. · Sep 2007