Ascension® PyroHemiSphere PHS44020WW

GUDID 10381780114543

The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Ascension Orthopedics, Inc.

Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis

• Primary Device ID: 10381780114543
• NIH Device Record Key: bc7ce78b-35ea-43e0-a271-5d525a141917
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ascension® PyroHemiSphere
• Version Model Number: PHS44020WW
• Catalog Number: PHS44020WW
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780114543 [Primary]
HIBCC	M268PHS44020WW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041451

FDA Product Code

• KYI: PROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2017-10-09

On-Brand Devices [Ascension® PyroHemiSphere]

• 10381780114574: The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb
• 10381780114567: The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb
• 10381780114550: The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb
• 10381780114543: The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb
• 10381780114536: The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb