Ascension® PyroCarbon Lunate LUN-710-05-WW

GUDID 10381780116288

The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentially the same shape as the native lunate bone. The Lunate implant acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision and to maintain mobility of the wrist. The articular concavity that captures the capitate is more exaggerated to enhance stability. The Lunate implant has two suture holes which allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability while a capsuloligamentous system forms around the implant. The Ascension® Pyrocarbon Lunate is constructed of a high strength On-X® PyroCarbon layer deposited on a graphite substrate. The graphite is impregnated with tungsten making the Lunate implant radiopaque. The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of Avascular necrosis (Kienboch’s disease), localized osteoarthritic, or changes in Long-Standing dislocations.

Ascension Orthopedics, Inc.

Carpal lunate prosthesis

• Primary Device ID: 10381780116288
• NIH Device Record Key: c3cef3f1-595e-467f-87b7-b440da4023eb
• Commercial Distribution Discontinuation: 2026-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension® PyroCarbon Lunate
• Version Model Number: LUN71005WW
• Catalog Number: LUN-710-05-WW
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780116288 [Primary]
HIBCC	M268LUN71005WW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080997

FDA Product Code

• KWN: PROSTHESIS, WRIST, CARPAL LUNATE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-02-23
• Device Publish Date: 2017-10-09

On-Brand Devices [Ascension® PyroCarbon Lunate]

• 10381780116288: The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentiall
• 10381780116271: The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentiall
• 10381780116264: The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentiall
• 10381780116257: The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentiall
• 10381780116240: The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentiall