Glenoid Baseplate

Glenoid Baseplate
REUNION - 5572-2802

A sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KWS

Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3660

Third Party Flag: N

Medical Specialty: OR

Code: PHX

Device Name: Shoulder Prosthesis, Reverse Configuration

Device Class: 2

Physical State: Typically includes humeral stem, humeral socket, humeral cup, glenosphere, and glenoid baseplate with fixation screws. The humeral stem and humeral socket may be one single piece or two separate pieces locked together. The humeral cup is snap fit into the humeral socket. The humeral cup is made from UHMWPE and articulates with the glenosphere made of CoCrMo alloy, Titanium alloy, or stainless steel. The glenosphere locks to glenoid baseplate which is fixed to the glenoid bone by 2-6 screws. The glenoid baseplate has HA coating, metallic coating or no coating and may feature a central peg, central screw, central cage, or keel.

Definition: Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Relative to the native shoulder joint, the device moves the center of rotation medially and distally to the anatomic position which increases the length of the deltoid muscle's lever arm, allowing the same rotational moment with less applied force.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Shoulder joint

Regulation Number: 888.3660

Third Party Flag: N

Medical Specialty: OR

Device Id: 07613327507096

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A