Cleared Traditional

K983136 - DEPUY LUSTER STEM

K983136 is an FDA 510(k) clearance for DEPUY LUSTER STEM, 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 78-day FDA review.

K983136 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
78d
Days
Class 2
Risk

K983136 is an FDA 510(k) clearance for the DEPUY LUSTER STEM. 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 November 25, 1998 after a review of 78 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 - K983136

510(k) Number K983136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date November 25, 1998
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 K983136.
OSTEONICS X CEMENTED HIP STEM SERIES
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150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
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K982918 · DePuy Orthopaedics, Inc. · Oct 1998
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OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
K974685 · Osteonics Corp. · Sep 1998