AccessGUDID - DEVICE: Ascension® PyroCarbon Lunate (10381780116288)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension® PyroCarbon Lunate
Version or Model: LUN71005WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LUN-710-05-WW
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780116288
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: 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.

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?
33706	Carpal lunate prosthesis	A sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWN	PROSTHESIS, WRIST, CARPAL LUNATE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080997	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: .5787in H x .7674in W; Size 5

Device Record Status

Public Device Record Key: c3cef3f1-595e-467f-87b7-b440da4023eb
Public Version Date: February 23, 2023
Public Version Number: 6
DI Record Publish Date: October 09, 2017