Titan™ STEM-0950-025-12125

GUDID 10381780364177

Total Shoulder System Cemented Long Stem, 12 x 125mm

Ascension Orthopedics, Inc.

Uncoated shoulder humeral stem prosthesis

• Primary Device ID: 10381780364177
• NIH Device Record Key: d400a1cb-2143-4652-92ca-79a4c96416a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan™
• Version Model Number: S95002512125
• Catalog Number: STEM-0950-025-12125
• 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

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780364177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142413

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-06-23
• Device Publish Date: 2018-09-06

On-Brand Devices [Titan™]

• 10381780471288: RSS Glenosphere Removal Handle-S
• 10381780459118: RSS Reamer Guide Body Inserter/Extractor
• 10381780459101: RSS Humeral Body Inserter/Extractor
• M269SEP09200680011: Titan™ Total Shoulder System The body separator is used in the removal of the proximal humeral
• M269INS0960049011: Titan™ Reverse Shoulder System The reamer guide body inserter/extractor is used to assist with
• M269IS09500450011: The humeral implant inserter/extractor is used to insert the implant into its place, as well as
• M269INS0960048021: The humeral body inserter/extractor knob is used to tighten or loosen the inserter/extractor.
• M269INS0960048011: The humeral body inserter/extractor is used to insert the implant into its place, as well as ext
• M269HDL0960065011: The glenosphere inserter is used to insert the glenosphere into the baseplate.
• M269SET188A0011: The head extractor is used to remove the humeral head.
• M269INS09500460011: The humeral trial inserter/extractor is used to insert the trial implant into its place, as well
• M269INS09230460011: The humeral trial inserter/extractor is used to insert the trial implant into its place, as well
• M269INS09230450011: The humeral implant inserter/extractor is used to insert the implant into its place, as well as
• M269INS09200460011: The humeral trial inserter/extractor is used to insert the trial implant into its place, as well
• M269INS09200450011: The humeral implant inserter/extractor is used to insert the implant into its place, as well as
• M269GLN092603003A1: The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
• M269GLN092603002A1: The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
• M269GLN092603001A1: The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
• M269GLN092603000A1: The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
• 10381780467601: RSS HXL Liner Retentive, +9R
• 10381780467595: RSS HXL Liner Retentive, +6R
• 10381780467588: RSS HXL Liner Retentive, +3R
• 10381780467571: RSS HXL Liner Retentive, +0R
• 10381780467564: RSS HXL Liner Standard, +9S
• 10381780467557: RSS HXL Liner Standard, +6S
• 10381780467540: RSS HXL Liner Standard, +3S
• 10381780467533: RSS HXL Liner Standard, +0S
• M269IMS0960070011: Titan™ Reverse Shoulder System The stand is used as a base during stem impaction.
• M269SCR0960062011: Titan™ Reverse Shoulder System The 2.5 Hex Driver is used to tighten 4.5mm screws.
• 10381780467779: RSS Double Drill Guide-S
• 10381780467762: RSS Baseplate Boss Drill Guide-S
• M269DRS09260011: The Glenoid Drill Shaft is used to create holes.
• M269DRL0926018S1: Fin-Lock Central Drill
• M269DRL0926018C1: Fin-Lock Cannulated Central Drill
• M269DRL0926015S1: Fin-Lock Central Drill
• M269DRL0926015C1: Fin-Lock Cannulated Central Drill
• M269DRL09260021: Fin-Lock Peripheral Drill
• M269DRL09260011: Fin-Lock Starter Drill
• M269DRG09260031: Fin-Lock Starter Drill Guide
• M269DRG09260021: Fin-Lock Starter Drill Guide
• M269DRG09260011: The Fin-Lock Drill Guide is used for precision and accuracy when drilling.
• M269STD09200710011: Titan™ Total Shoulder System The stand is used as a base during head impaction.
• M269SIS09200540011: Titan™ Total Shoulder System The stand is used as a base during stem impaction.
• M269INS0920071STD1: Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
• M269INS0920071SML1: Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
• M269INS0920071LRG1: Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
• M269DRG0922067021: Titan™ Total Shoulder System The glenoid drill guide is used for precision and accuracy when d
• M269DRG0922067011: Titan™ Total Shoulder System The glenoid drill guide is used for precision and accuracy when d
• M269DRG09200490021: Titan™ Total Shoulder System The center glenoid drill guide is used for precision and accuracy
• M269DRG09200490011: Titan™ Total Shoulder System The center glenoid drill guide is used for precision and accuracy