Titan™

Basic Information

• Brand Name: Titan™
• Primary DI: 10381780234975
• Version / Model: HRARTHIMP
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 4
• Public Version Date: 2023-05-02
• Public Version Status: Update
• Public Device Record Key: 4ac868af-0526-4090-a8e7-76bf34a76f8b
• Distribution End Date: 2023-03-31

Device Description

The Titan Humeral Resurfacing Arthroplasty system is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis, mild or moderate humeral head deformity and/or limited motion, post-traumatic arthritis, and patients with an intact or reparable rotator cuff. The set includes HRA trials to evaluate the size and fit of the appropriate implant, as well as sizers to determine the amount of bone resection needed for the implant. Instruments are also included to assist with the trials.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44758	General external orthopaedic fixation system implantation kit, reusable	A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M268HRARTHIMP1	HIBCC
Primary	10381780234975	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062861	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			22.4 in L x 10.8 in W x 6.3 in H