Cleared Traditional

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD (K960424) - FDA 510(k) Clearance

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

K960424 · Endotec, Inc. · Orthopedic device
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Aug 1996
Decision
210d
Days
Class 2
Risk

K960424 is an FDA 510(k) clearance for the BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Endotec, Inc. (Bloomfield, US). The FDA issued a Cleared decision on August 26, 1996 after a review of 210 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Endotec, Inc. devices

Submission Details

510(k) Number K960424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date August 26, 1996
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 43
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K960424.
BIPOLAR SHOULDER PROSTHESIS
K991585 · Biomet, Inc. · Aug 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · DePuy Orthopaedics, Inc. · Jan 1999
NEW ZIMMER SHOULDER SYSTEM
K982981 · Zimmer, Inc. · Dec 1998
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · Biomet, Inc. · Aug 1996
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · Biomet, Inc. · Oct 1994
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · Biomet, Inc. · Mar 1992