CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (5) Shoulder Prosthesis, Reverse Configuration (PHX) (5)

Premarket Exempt

Clear

SmartBone Mount - 00811813020204 Catalog Number : 0006-0006

Device Description : The SmartBone Mount is a device used to hold the SmartBone at the time of surger 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 Class : 2

Duns Number: 078667390

Premarket Exempt : No

Product Code : PHX, KWS

Prescription Use : Yes

Device Count : 1

SmartBone - 00811813020235 Catalog Number : 0006-0007-UPI

Device Description : The SmartBone is a 3D-printed, patient-specific device that is used to set the G 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 Class : 2

Duns Number: 078667390

Premarket Exempt : No

Product Code : PHX, KWS

Prescription Use : Yes

Device Count : 1

SmartBase Ruler - 00811813020280 Catalog Number : 0006-0031

Device Description : The SmartBase Ruler is a component of the SmartBase Assembly, which is used to s The SmartBase Ruler is a component of the SmartBase Assembly, which is used to set the Intelligent Reusable Instrument (IRI). The SmartBase Assembly is indicated for use as part of the Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).

Device Class : 2

Duns Number: 078667390

Premarket Exempt : No

Product Code : PHX, KWS

Prescription Use : Yes

Device Count : 1

SmartBase Core - 00811813020297 Catalog Number : 0006-0032

Device Description : The SmartBase Core is the base component of the SmartBase Assembly, which is use The SmartBase Core is the base component of the SmartBase Assembly, which is used to set the Intelligent Reusable Instrument (IRI). The SmartBase Assembly is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).

Device Class : 2

Duns Number: 078667390

Premarket Exempt : No

Product Code : PHX, KWS

Prescription Use : Yes

Device Count : 1

SmartBase Central Pillar - 00811813020303 Catalog Number : 0006-0033

Device Description : The SmartBase Central Pillar is a component of the SmartBase that holds the guid The SmartBase Central Pillar is a component of the SmartBase that holds the guide pin to set the Intelligent Reusable Instrument (IRI) according to a patient-specific preoperative plan. The SmartBase Central Pillar is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).

Device Class : 2

Duns Number: 078667390

Premarket Exempt : No

Product Code : PHX, KWS

Prescription Use : Yes

Device Count : 1

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