Ascension® PyroCarbon Lunate LUN-710-04-WW

GUDID 10381780116271

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 ID10381780116271
NIH Device Record Keyef7bf467-77f7-4027-97bf-2d05068d5f23
Commercial Distribution Discontinuation2026-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameAscension® PyroCarbon Lunate
Version Model NumberLUN71004WW
Catalog NumberLUN-710-04-WW
Company DUNS942377524
Company NameAscension Orthopedics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780116271 [Primary]
HIBCCM268LUN71004WW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWNPROSTHESIS, WRIST, CARPAL LUNATE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-02-23
Device Publish Date2017-10-09

On-Brand Devices [Ascension® PyroCarbon Lunate]

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

Trademark Results [Ascension]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASCENSION
ASCENSION
98590880 not registered Live/Pending
MAJESTIC SMOKERS, INC.
2024-06-07
ASCENSION
ASCENSION
98344823 not registered Live/Pending
SWIFT CITY OUTLET INC
2024-01-05
ASCENSION
ASCENSION
98188558 not registered Live/Pending
Ascension Health Alliance
2023-09-20
ASCENSION
ASCENSION
98167571 not registered Live/Pending
Ascension Health Alliance
2023-09-06
ASCENSION
ASCENSION
98167559 not registered Live/Pending
Ascension Health Alliance
2023-09-06
ASCENSION
ASCENSION
98167555 not registered Live/Pending
Ascension Health Alliance
2023-09-06
ASCENSION
ASCENSION
98167549 not registered Live/Pending
Ascension Health Alliance
2023-09-06
ASCENSION
ASCENSION
98167541 not registered Live/Pending
Ascension Health Alliance
2023-09-06
ASCENSION
ASCENSION
98094242 not registered Live/Pending
True Anomaly, Inc.
2023-07-20
ASCENSION
ASCENSION
97715942 not registered Live/Pending
Bread Winner Alumni LLC
2022-12-13
ASCENSION
ASCENSION
97464556 not registered Live/Pending
Herrera, Daniel
2022-07-24
ASCENSION
ASCENSION
97410777 not registered Live/Pending
Commerce c.labs Inc
2022-05-14

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