Cleared Traditional

METHA HIP SYSTEM (K071916) - FDA 510(k) Clearance

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

K071916 · Aesculap Implant Systems, Inc. · Orthopedic device
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Jun 2008
Decision
327d
Days
Class 2
Risk

K071916 is an FDA 510(k) clearance for the METHA 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 Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on June 2, 2008 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aesculap Implant Systems, Inc. devices

Submission Details

510(k) Number K071916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2007
Decision Date June 02, 2008
Days to Decision 327 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
205d slower than avg
Panel avg: 122d · This submission: 327d
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 101
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K071916.
REJUVENATE MONOLITHIC HIP SYSTEM
K082892 · Howmedica Osteonics Corp. · Dec 2008
MDF REVISION HIP SYSTEM
K081124 · Smith & Nephew, Inc. · Jul 2008
REJUVENATE MODULAR HIP SYSTEM
K081044 · Howmedica Osteonics Corp. · 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