Cleared Traditional

K123991 - DEPUY CORAIL AMT HIP PROSTHESIS (FDA 510(k) Clearance)

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

K123991 · Depuy France S.A.S. · Orthopedic device
Sep 2013
Decision
264d
Days
Class 2
Risk

K123991 is an FDA 510(k) clearance for the DEPUY CORAIL AMT HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Depuy France S.A.S. (Warsaw, US). The FDA issued a Cleared decision on September 16, 2013 after a review of 264 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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.

Submission Details

510(k) Number K123991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date September 16, 2013
Days to Decision 264 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 116d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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.