Cleared Traditional

K013352 - SUMMIT CEMENTED HIP PROSTHESIS

K013352 is an FDA 510(k) clearance for SUMMIT CEMENTED HIP PROSTHESIS, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K013352 · DePuy Orthopaedics, Inc. · Orthopedic device
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Dec 2001
Decision
69d
Days
Class 2
Risk

K013352 is an FDA 510(k) clearance for the SUMMIT CEMENTED HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 2001 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K013352

510(k) Number K013352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date December 17, 2001
Days to Decision 69 days
Submission Type Traditional
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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K013352.
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