Cleared Traditional

K080584 - METHA SHORT STEM HIP SYSTEM

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

K080584 · Aesculap Implant System, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K080584

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
Combination Product No
PCCP Authorized No
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.

MEH Device Classification - Class 2, Special Controls

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 Consultant

Aesculap AG
Kathy Racosky

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 152
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K080584.
MDF REVISION HIP SYSTEM
K081124 · Smith & Nephew, Inc. · Jul 2008
REJUVENATE MODULAR HIP SYSTEM
K081044 · Howmedica Osteonics Corp. · Jun 2008
METHA HIP SYSTEM
K071916 · Aesculap Implant Systems, Inc. · Jun 2008
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