Single Handle Cannulated Centering Guide

Single Handle Cannulated Centering Guide
REUNION - 5901-6060

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

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

Code: HSD

Device Name: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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: 888.3690

Third Party Flag: N

Medical Specialty: OR

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

Device Id: 07613327603361

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