PyroHemiSphereTM

GUDID M268PYROHEMIINSP1

The Ascension® PyroHemiSphereTM 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.

General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: M268PYROHEMIINSP1
• NIH Device Record Key: 034cc1fe-557e-4338-99df-a749a0ab65fe
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PyroHemiSphereTM
• Version Model Number: PYROHEMIINSP
• 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: 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

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	10381780235033 [Primary]
HIBCC	M268PYROHEMIINSP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041451

FDA Product Code

• KYI: PROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

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

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

[M268PYROHEMIINSP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2016-08-15

Devices Manufactured by Ascension Orthopedics, Inc.

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• 10381780123026 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123033 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123040 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123057 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123064 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• M26922286111 - Integra®: 2023-09-18 Integra® Total Foot System K-Wire is used for temporary fixation.