SmartBone Mount

Basic Information

• Brand Name: SmartBone Mount
• Primary DI: 00811813020204
• Version / Model: L
• Catalog Number: 0006-0006
• Company Name: CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
• Labeler DUNS: 078667390
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 5
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: a1fcd552-c047-4571-a5d9-3381ac7f80e2

Device Description

The SmartBone Mount is a device used to hold the SmartBone at the time of surgery. The SmartBone Mount holds the SmartBone so that the trajectory of the guide pin is vertical, allowing for easier setting of the Intelligent Reusable Instrument (IRI). The SmartBone Mount is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).

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: MR Unsafe
• 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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	888.3660	2
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13180	Orthopaedic prosthesis implantation positioning instrument, reusable	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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
Primary	00811813020204	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	44	Millimeter
Outer Diameter	69.8	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, dark, cool place