Cleared Traditional

K023692 - GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER

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

K023692 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K023692

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.

LWJ Device Classification - Class 2, Special Controls

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 71
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