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 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 IDM268PYROMCPINSTP1
NIH Device Record Key4d4ced5a-7882-4da8-b7b3-0a09d255ac9c
Commercial Distribution Discontinuation2023-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAscension®
Version Model NumberPYROMCPINSTP
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780235057 [Primary]
HIBCCM268PYROMCPINSTP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYJPROSTHESIS, FINGER, CONSTRAINED, POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-02
Device Publish Date2016-08-15

On-Brand Devices [Ascension®]

M269CSA100061Integra®Surgical Instruments The MCP Caddy is a smaller, removable container that rests within
M269CSA100051Integra®Surgical Instruments The Base is the bottom portion wherein devices are placed.
M269OSG10000P1Ascension® MCP Osteotomy Guide, Proximal
M269OSG10000D1Ascension® MCP Osteotomy Guide, Distal
M269IMP10000P1Ascension® MCP Proximal impactor
M269IMP10000D1Ascension® MCP Distal impactor
M269BRH10105P1MCP Proximal Cutting Broach Sz. 05
M269BRH10105D1MCP Distal Cutting Broach Sz. 05
M269BRH10040P1MCP, Broach, Proximal, Sz. 40
M269BRH10040D1MCP, Broach, Distal, Sz. 40
M269BRH10030P1MCP, Broach, Proximal, Sz. 30
M269BRH10030D1MCP, Broach, Distal, Sz. 30
M269BRH10020P1MCP, Broach, Proximal, Sz. 20
M269BRH10020D1MCP, Broach, Distal, Sz. 20
M269BRH10010P1MCP, Broach, Proximal, Sz. 10
M269BRH10010D1MCP, Broach, Distal, Sz. 10
M269TRL500401Ascension® Silicone MCP, SMCP Trial Size 40
M269TRL500301Ascension® Silicone MCP, SMCP Trial Size 30
M269TRL500201Ascension® Silicone MCP, SMCP Trial Size 20
M269TRL500101Ascension® Silicone MCP, SMCP Trial Size 10
M269TRL10140P1Ascension® MCP Proximal Metal Trial Size 40
M269TRL10140D1Ascension® MCP Distal Metal Trial Size 40
M269TRL10130P1Ascension® MCP Proximal Metal Trial Size 30
M269TRL10130D1Ascension® MCP Distal Metal Trial Size 30
M269TRL10120P1Ascension® MCP Proximal Metal Trial Size 20
M269TRL10120D1Ascension® MCP Distal Metal Trial Size 20
M269TRL10110P1Ascension® MCP Proximal Metal Trial Size 10
M269TRL10110D1Ascension® MCP Distal Metal Trial Size 10
M269TRL10105P1Ascension® MCP Proximal Metal Trial Size 05
M269TRL10105D1Ascension® MCP Distal Metal Trial Size 05
M269TRL500051Ascension® Silicone MCP, SMCP Trial Size 05
M269CSA500021Ascension® PIP Silicone MCP The Silicone MCP Base is the bottom portion wherein devices are pla
M269CSA500011Ascension® PIP Silicone MCP The Silicone MCP Lid is the top part of the case which locks onto
M269TRL500501The Silicone MCP Trial is used to evaluate component collar contact on osteotomy and stem fit in
M269TRL10150P1The Proximal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit
M269TRL10150D1The Distal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit in
M268SILMCPINSTP1The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint wh
M268PYROMCPINSTP1The Ascension MCP is indicated for use as a total joint replacement of index, long, ring, and sm

Trademark Results [Ascension]

Mark Image

Registration | Serial
Company
Trademark
Application Date
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
ASCENSION
ASCENSION
97384508 not registered Live/Pending
Proof Research, Inc.
2022-04-27
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