Cleared Traditional

K955916 - TOWNLEY TOTAL ELBOW SYSTEM

K955916 is an FDA 510(k) clearance for TOWNLEY TOTAL ELBOW SYSTEM, manufactured by Biologically Oriented Prostheses. The device is a Class 2 Orthopedic device with product code JDC cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K955916 · Biologically Oriented Prostheses · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
223d
Days
Class 2
Risk

K955916 is an FDA 510(k) clearance for the TOWNLEY TOTAL ELBOW SYSTEM. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Biologically Oriented Prostheses (Port Huron, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 223 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 Biologically Oriented Prostheses devices

FDA 510(k) Submission Details - K955916

510(k) Number K955916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1995
Decision Date August 08, 1996
Days to Decision 223 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
101d slower than avg
Panel avg: 122d · This submission: 223d
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 27
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K955916.
BIOMET BIAXIAL TOTAL ELBOW
K980428 · Biomet, Inc. · May 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · Osteonics Corp. · May 1998
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
K973357 · Zimmer, Inc. · Mar 1998
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