Titan™ Total Shoulder System

Basic Information

• Brand Name: Titan™ Total Shoulder System
• Primary DI: 10381780120612
• Version / Model: SEM095002508
• Catalog Number: STEM-0950-025-08
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 5
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 0ffc8928-fb92-4750-b14c-205779255331
• Distribution End Date: 2026-12-31

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
39702	Coated shoulder humeral stem prosthesis	A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780120612	GS1
Secondary	M268STEM0950025081	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142413	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.86 in L x .320 in dia; Size 08