Cleared Special

METHA SHORT STEM HIP SYSTEM (K081973) - FDA 510(k) Clearance

Also marketed or referenced as:
MODULAR HIP SYSTEM EXCIA HIP SYSTEM

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081973 · Aesculap Implant Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
28d
Days
Class 2
Risk

K081973 is an FDA 510(k) clearance for the METHA SHORT STEM HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap Implant Systems, Inc. devices

Submission Details

510(k) Number K081973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2008
Decision Date August 07, 2008
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K081973.
BIOLOX DELTA OPTION CERAMIC HEADS
K082996 · Biomet, Inc. · Jan 2009
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · Exactech, Inc. · Dec 2008
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