Cleared Traditional

OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS (K974685) - FDA 510(k) Clearance

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

K974685 · Osteonics Corp. · Orthopedic device
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Sep 1998
Decision
280d
Days
Class 2
Risk

K974685 is an FDA 510(k) clearance for the OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS. 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 September 22, 1998 after a review of 280 days - an extended review 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: 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 Osteonics Corp. devices

Submission Details

510(k) Number K974685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1997
Decision Date September 22, 1998
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
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 K974685.
DEPUY LUSTER STEM
K983136 · DePuy Orthopaedics, Inc. · Nov 1998
DEPUY C-STEM SYSTEM
K982918 · DePuy Orthopaedics, Inc. · Oct 1998
CONTEMPORARY ACETABULAR COMPONENT
K982670 · Howmedica Corp. · Oct 1998
DUAL LOCK HIP STEM
K980794 · Depuy, Inc. · May 1998
ARTICUL/EZE FEMORAL HEADS
K980513 · DePuy Orthopaedics, Inc. · Apr 1998
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K980286 · Johnson & Johnson Professionals, Inc. · Apr 1998