Cleared Traditional

K980513 - ARTICUL/EZE FEMORAL HEADS

K980513 is an FDA 510(k) clearance for ARTICUL/EZE FEMORAL HEADS, 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 63-day FDA review.

K980513 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
63d
Days
Class 2
Risk

K980513 is an FDA 510(k) clearance for the ARTICUL/EZE FEMORAL HEADS. 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 April 14, 1998 after a review of 63 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 - K980513

510(k) Number K980513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1998
Decision Date April 14, 1998
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K980513.
EXETER INTRAMEDULLARY BONE PLUG
K980843 · Howmedica, Inc. · Jun 1998
DUAL LOCK HIP STEM
K980794 · Depuy, Inc. · May 1998
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K980486 · Implex Corp. · Apr 1998
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K980286 · Johnson & Johnson Professionals, Inc. · Apr 1998
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
K974558 · Biomet, Inc. · Mar 1998
ENCORE LINEAR HIP
K972791 · Encore Orthopedics, Inc. · Jan 1998