PMA P000035S009

Device: TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
Applicant: Nexus CMF, LLC
PMA number: P000035
Supplement: S009
Product code: MPI
Decision date: 2014-06-02
Generic name: Glenoid fossa prosthesis
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED LENGTHS, TO STANDARDIZE THE SCREW THREAD PROFILE AND PITCH, TO INCREASE THE LENGTH OF THE THREADED PORTION OF THE BONE SCREW, TO ROUND THE TIP OF THE SCREW, TO ADD A FILLET BETWEEN THE SCREW HEAD AND SCREW SHAFT, TO STANDARDIZE DIMENSIONS OF CERTAIN GEOMETRICAL FEATURES OF THE BONE SCREWS (THE SCREW HEAD CROWN RADIUS AND DRIVER SLOT DEPTH), TO STANDARDIZE THE MINOR DIAMETER, AND TO INTRODUCE TI-6AL-4V ALLOY BONE SCREWS.

Current openFDA PMA Record#

Device: TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
Applicant: Nexus CMF, LLC
PMA number: P000035
Supplement: S009
Product code: MPI
Generic name: Glenoid fossa prosthesis
Decision date: 2014-06-02
Decision code: APPR
Date received: 2014-03-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED LENGTHS, TO STANDARDIZE THE SCREW THREAD PROFILE AND PITCH, TO INCREASE THE LENGTH OF THE THREADED PORTION OF THE BONE SCREW, TO ROUND THE TIP OF THE SCREW, TO ADD A FILLET BETWEEN THE SCREW HEAD AND SCREW SHAFT, TO STANDARDIZE DIMENSIONS OF CERTAIN GEOMETRICAL FEATURES OF THE BONE SCREWS (THE SCREW HEAD CROWN RADIUS AND DRIVER SLOT DEPTH), TO STANDARDIZE THE MINOR DIAMETER, AND TO INTRODUCE TI-6AL-4V ALLOY BONE SCREWS.