Cleared Traditional

K901581 - GSB ELBOW

K901581 is an FDA 510(k) clearance for GSB ELBOW, manufactured by Allo Pro Corp.. The device is a Class 2 Orthopedic device with product code JDC cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K901581 · Allo Pro Corp. · Orthopedic device
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Oct 1990
Decision
201d
Days
Class 2
Risk

K901581 is an FDA 510(k) clearance for the GSB ELBOW. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Allo Pro Corp. (Clearwater, US). The FDA issued a Cleared decision on October 22, 1990 after a review of 201 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - 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 Allo Pro Corp. devices

FDA 510(k) Submission Details - K901581

510(k) Number K901581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1990
Decision Date October 22, 1990
Days to Decision 201 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 122d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDC Device Classification - Class 2, Special Controls

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
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 - JDC Prosthesis, Elbow, Constrained, Cemented

All 28
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K901581.
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · Osteonics Corp. · May 1998
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
K973357 · Zimmer, Inc. · Mar 1998
TOWNLEY TOTAL ELBOW SYSTEM
K955916 · Biologically Oriented Prostheses · Aug 1996
PNEUMOTHORAX KIT, MODIFICATION
K904021 · Arrow Intl., Inc. · Oct 1990
COONRAD III TOTAL ELBOW
K883665 · Zimmer, Inc. · Feb 1989
POROCOAT MARK II TOTAL ELBOW
K872084 · Depuy, Inc. · Jun 1987