Cleared Traditional

K080584 - METHA SHORT STEM HIP SYSTEM

K080584 is the FDA 510(k) clearance for METHA SHORT STEM HIP SYSTEM by Aesculap Implant System, Inc.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K080584 · Aesculap Implant System, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2008
Decision
67d
Days
Class 2
Risk

K080584 is an FDA 510(k) clearance for the METHA SHORT STEM HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 9, 2008 after a review of 67 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 Aesculap Implant System, Inc. devices

Submission Details

510(k) Number K080584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date May 09, 2008
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 127
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K080584.
REJUVENATE MONOLITHIC HIP SYSTEM
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REJUVENATE MODULAR HIP SYSTEM
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EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980 · Exactech, Inc. · May 2008
RESTORATION ADM SYSTEM
K072020 · Howmedica Osteonics Corp. · Oct 2007
EXCIA TOTAL HIP SYSTEM WITH U-CAP
K060437 · Aesculap, Inc. · Mar 2006