Cleared Traditional

K123991 - DEPUY CORAIL AMT HIP PROSTHESIS

K123991 is the FDA 510(k) clearance for DEPUY CORAIL AMT HIP PROSTHESIS by Depuy France S.A.S.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K123991 · Depuy France S.A.S. · Orthopedic device
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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.

View all Depuy France S.A.S. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 122d · 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.

Regulatory Peers - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 74
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K123991.
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