Titan™ Total Shoulder System GLN092003002P

GUDID 10381780120209

The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total replacement Arthroplasty and provide stable fixation, proximal bone loading, and proper head placement. The glenoid component is intended for use of correction of humeral joint due to severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. The component is also used in repairing fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory as well as other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).

Ascension Orthopedics, Inc.

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 10381780120209
• NIH Device Record Key: 1b89a3a8-8139-442b-9f51-3e37c3607290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan™ Total Shoulder System
• Version Model Number: GLN092003002P
• Catalog Number: GLN092003002P
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780120209 [Primary]
HIBCC	M269GLN092003002P1 [Secondary]

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-10-09

On-Brand Devices [Titan™ Total Shoulder System]

• 10381780120223: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
• M269GLN092003003K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• 10381780120209: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
• M269GLN092003002K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• M269GLN092003001P1: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
• M269GLN092003001K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• M269GLN092003000P1: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal
• M269GLN092003000K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• 10381780422716: TSS Modified Retractor Base
• 10381780364818: TSS PIN BUSHING, 2.5 M-L
• M269MHH09230105220E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230105220C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230105022E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230105022C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230105019E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230105019C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104821E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104821C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104818E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104818C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104815E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104815C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104620E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104620C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104617E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104617C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104614E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104614C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104419E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104419C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104416E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104416C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104216E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104216C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104015E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230103814E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269BOD092302108STD1: The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
• M269BOD092302108SML1: The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
• M269BOD092302108LRG1: The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
• M269BOD092302014STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302014SML1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302014LRG1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302012STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302010STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302010SML1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123163: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302008STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123149: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123132: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123125: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi