Cleared Traditional

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

K960424 is an FDA 510(k) clearance for BUECHEL-PAPPAS POLYETHYLENE GLENOID COM..., manufactured by Endotec, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 210-day FDA review.

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

FDA 510(k) Submission Details - K960424

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.

KWT Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K960424.
NEW ZIMMER SHOULDER SYSTEM
K982981 · Zimmer, Inc. · Dec 1998
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
K970567 · Intermedics Orthopedics · Feb 1997
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962315 · Intermedics Orthopedics · Sep 1996
SELECT SHOULDER KEELED ALL-POLY GLENOIDS
K962238 · Intermedics Orthopedics · Aug 1996
SELECT SHOULDER PEGGED ALL-POLY GLENOID
K962244 · Intermedics Orthopedics · Aug 1996
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · Biomet, Inc. · Aug 1996