Cleared Traditional

OSTEONICS X CEMENTED HIP STEM SERIES (K983226) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983226 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
80d
Days
Class 2
Risk

K983226 is an FDA 510(k) clearance for the OSTEONICS X CEMENTED HIP STEM SERIES. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 80 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 Osteonics Corp. devices

Submission Details

510(k) Number K983226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date December 04, 1998
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K983226.
APF POROUS COATED LINE EXTENSION
K984154 · Biomet, Inc. · Feb 1999
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
K980926 · Howmedica Corp. · Dec 1998
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
K980626 · Howmedica Corp. · Dec 1998
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
K983710 · Biomet, Inc. · Dec 1998
DEPUY LUSTER STEM
K983136 · DePuy Orthopaedics, Inc. · Nov 1998
DEPUY C-STEM SYSTEM
K982918 · DePuy Orthopaedics, Inc. · Oct 1998