Titan™

Basic Information

• Brand Name: Titan™
• Primary DI: 10381780124344
• Version / Model: T95012008LRG
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 5
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: fa5f5ed1-37db-460d-a1cd-e2809e355382
• Distribution End Date: 2026-12-31

Device Description

The Definitive Fracture Body Trial is used to evaluate the size and fit of the implant.

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
60935	Humeral body prosthesis trial	A copy of a final humeral body prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It connects to a humeral stem prosthesis and articulates with a standard humeral head prosthesis, or connects to a reverse shoulder prosthesis cup, and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269TRL095012008LRG1	HIBCC
Primary	10381780124344	GS1

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			08 Large