Titan™ Total Shoulder System STEM-0950-025-06

GUDID 10381780120605

The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.

Ascension Orthopedics, Inc.

Coated shoulder humeral stem prosthesis

• Primary Device ID: 10381780120605
• NIH Device Record Key: 1227d53b-a79b-46ae-979a-b5753aa3f664
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan™ Total Shoulder System
• Version Model Number: SEM095002506
• Catalog Number: STEM-0950-025-06
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780120605 [Primary]
HIBCC	M268STEM0950025061 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142413

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: 4
• Public Version Date: 2020-06-23
• 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