Universal 2™ Total Wrist System UNI2SET

GUDID M268UNI2SET0

The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint, as well as corresponding instrumentation. The radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal. It is manufactured from cast CoCr alloy. The carpal component is a titanium plate which is fixed into the carpal bones with a cemented central peg and two titanium screws. Instrumentation is provided to assist in the surgical implantation.

INTEGRA LIFESCIENCES CORPORATION

Total wrist prosthesis

• Primary Device ID: M268UNI2SET0
• NIH Device Record Key: ad516745-2fb3-4f95-9e52-2137bfdad7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal 2™ Total Wrist System
• Version Model Number: UNI2SET
• Catalog Number: UNI2SET
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064336 [Primary]
HIBCC	M268UNI2SET0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030037

FDA Product Code

• JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

[M268UNI2SET0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-16
• Device Publish Date: 2015-08-15

On-Brand Devices [Universal 2™ Total Wrist System]

• M268UNI2SET0: The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists
• M248264535S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264530S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264525S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264520S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M268263800RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263800LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263700RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263700LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263600RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263600LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263500RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263500LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263400RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263400LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263300RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263300LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263200RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263200LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263100RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263100LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M2482624021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482624011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482624001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482623021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482623011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482623001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482622021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482622011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482622001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482621021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482621011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482621001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482614011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482613011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482612011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482611011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482645351: The Universal 2 Total Wrist cancellous bone screw implant.
• M2482645301: The Universal 2 Total Wrist cancellous bone screw implant.
• M2482645201: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264515S1: The Universal 2 Total Wrist cancellous bone screw implant.