Cleared Special

K082146 - METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD

K082146 is an FDA 510(k) clearance for METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD, manufactured by Aesculap Implant Systems, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Special 510(k) pathway after a 41-day FDA review.

K082146 · Aesculap Implant Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
41d
Days
Class 2
Risk

K082146 is an FDA 510(k) clearance for the METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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

FDA 510(k) Submission Details - K082146

510(k) Number K082146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date September 09, 2008
Days to Decision 41 days
Submission Type Special
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
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 63
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K082146.
TRINITY ACETABULAR SYSTEM
K103518 · Corin USA · Mar 2011
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · Exactech, Inc. · Apr 2009
EXCIA
K061699 · Aesculap, Inc. · Aug 2006
BETACONE HIP PROSTHESIS SYSTEM
K051826 · Waldemar Link GmbH & Co. KG · Nov 2005
EXCIA TOTAL HIP SYSTEM
K042344 · Aesculap, Inc. · Mar 2005
MODULAR PLUS HIP STEM
K032709 · Plus Orthopedics · Sep 2003