Cleared Traditional

K023692 - GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER

K023692 is the FDA 510(k) clearance for GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LWJ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K023692 · Howmedica Osteonics Corp. · Orthopedic device
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Mar 2003
Decision
136d
Days
Class 2
Risk

K023692 is an FDA 510(k) clearance for the GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K023692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2002
Decision Date March 20, 2003
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 57
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K023692.
MODULAR PLUS HIP STEM
K032709 · Plus Orthopedics · Sep 2003
PROCLASS PRESS FIT HIP STEM
K032110 · Stelkast Company · Sep 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · Plus Orthopedics · Apr 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · DePuy Orthopaedics, Inc. · Feb 2003
UNI HIP STEM
K024134 · Plus Orthopedics · Jan 2003
PROXILOCK HIP PROSTHESIS
K022966 · Implex Corp. · Oct 2002