AccessGUDID - DEVICE: SmartBone (00811813020235)

GUDID

Device Identifier (DI) Information

Brand Name: SmartBone
Version or Model: A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0006-0007-UPI
Company Name: CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Primary DI Number: 00811813020235
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 078667390 *Terms of Use

Device Description: The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58927	Orthopaedic prosthesis implantation positioning instrument, single-use	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, prosthesis, or prosthesis component; 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHX	Shoulder Prosthesis, Reverse Configuration
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry, dark, cool place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Patient-specific

Device Record Status

Public Device Record Key: 46a70ae7-2183-4098-9427-d1a49aeb29e4
Public Version Date: March 12, 2024
Public Version Number: 7
DI Record Publish Date: September 02, 2016