Cleared Traditional

K123991 - DEPUY CORAIL AMT HIP PROSTHESIS

K123991 is an FDA 510(k) clearance for DEPUY CORAIL AMT HIP PROSTHESIS, manufactured by Depuy France S.A.S.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K123991

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
Combination Product No
PCCP Authorized No
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.

KWY Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K123991.
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