Ascension®

GUDID M268PYROMCPINSTP1

The Ascension MCP is indicated for use as a total joint replacement of index, long, ring, and small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization. The set includes proximal trials, distal trials, and silicone trials to evaluate the size and fit of the appropriate implant. Instruments are included to assist with the trials.

Ascension Orthopedics, Inc.

General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: M268PYROMCPINSTP1
• NIH Device Record Key: 4d4ced5a-7882-4da8-b7b3-0a09d255ac9c
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ascension®
• Version Model Number: PYROMCPINSTP
• 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	10381780235057 [Primary]
HIBCC	M268PYROMCPINSTP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022892

FDA Product Code

• KYJ: PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Sterilization

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

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

Moist Heat or Steam Sterilization

[M268PYROMCPINSTP1]

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

On-Brand Devices [Ascension®]

• M269CSA100061: Integra®Surgical Instruments The MCP Caddy is a smaller, removable container that rests within
• M269CSA100051: Integra®Surgical Instruments The Base is the bottom portion wherein devices are placed.
• M269OSG10000P1: Ascension® MCP Osteotomy Guide, Proximal
• M269OSG10000D1: Ascension® MCP Osteotomy Guide, Distal
• M269IMP10000P1: Ascension® MCP Proximal impactor
• M269IMP10000D1: Ascension® MCP Distal impactor
• M269BRH10105P1: MCP Proximal Cutting Broach Sz. 05
• M269BRH10105D1: MCP Distal Cutting Broach Sz. 05
• M269BRH10040P1: MCP, Broach, Proximal, Sz. 40
• M269BRH10040D1: MCP, Broach, Distal, Sz. 40
• M269BRH10030P1: MCP, Broach, Proximal, Sz. 30
• M269BRH10030D1: MCP, Broach, Distal, Sz. 30
• M269BRH10020P1: MCP, Broach, Proximal, Sz. 20
• M269BRH10020D1: MCP, Broach, Distal, Sz. 20
• M269BRH10010P1: MCP, Broach, Proximal, Sz. 10
• M269BRH10010D1: MCP, Broach, Distal, Sz. 10
• M269TRL500401: Ascension® Silicone MCP, SMCP Trial Size 40
• M269TRL500301: Ascension® Silicone MCP, SMCP Trial Size 30
• M269TRL500201: Ascension® Silicone MCP, SMCP Trial Size 20
• M269TRL500101: Ascension® Silicone MCP, SMCP Trial Size 10
• M269TRL10140P1: Ascension® MCP Proximal Metal Trial Size 40
• M269TRL10140D1: Ascension® MCP Distal Metal Trial Size 40
• M269TRL10130P1: Ascension® MCP Proximal Metal Trial Size 30
• M269TRL10130D1: Ascension® MCP Distal Metal Trial Size 30
• M269TRL10120P1: Ascension® MCP Proximal Metal Trial Size 20
• M269TRL10120D1: Ascension® MCP Distal Metal Trial Size 20
• M269TRL10110P1: Ascension® MCP Proximal Metal Trial Size 10
• M269TRL10110D1: Ascension® MCP Distal Metal Trial Size 10
• M269TRL10105P1: Ascension® MCP Proximal Metal Trial Size 05
• M269TRL10105D1: Ascension® MCP Distal Metal Trial Size 05
• M269TRL500051: Ascension® Silicone MCP, SMCP Trial Size 05
• M269CSA500021: Ascension® PIP Silicone MCP The Silicone MCP Base is the bottom portion wherein devices are pla
• M269CSA500011: Ascension® PIP Silicone MCP The Silicone MCP Lid is the top part of the case which locks onto
• M269TRL500501: The Silicone MCP Trial is used to evaluate component collar contact on osteotomy and stem fit in
• M269TRL10150P1: The Proximal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit
• M269TRL10150D1: The Distal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit in
• M268SILMCPINSTP1: The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint wh
• M268PYROMCPINSTP1: The Ascension MCP is indicated for use as a total joint replacement of index, long, ring, and sm