Cleared Traditional

K112470 - 2GC HIP/KNEE MODULAR SPACER

K112470 is an FDA 510(k) clearance for 2GC HIP/KNEE MODULAR SPACER, manufactured by Mandell Horwitz Consultants, LLC. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K112470 · Mandell Horwitz Consultants, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
223d
Days
Class 2
Risk

K112470 is an FDA 510(k) clearance for the 2GC HIP/KNEE MODULAR SPACER. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Mandell Horwitz Consultants, LLC (Fairfax, US). The FDA issued a Cleared decision on April 5, 2012 after a review of 223 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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. Standard predicate reliance. 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 Mandell Horwitz Consultants, LLC devices

FDA 510(k) Submission Details - K112470

510(k) Number K112470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2011
Decision Date April 05, 2012
Days to Decision 223 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
101d slower than avg
Panel avg: 122d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWL Device Classification - Class 2, Special Controls

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
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 Peers - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 88
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K112470.
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K063791 · Corin USA · Apr 2007