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Ascension® NuGrip®

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Ascension® NuGrip® FDA UDI
Generic Name
Metacarpal prosthesis FDA UDI
Device Name
The Ascension® NuGrip® is an uncemented, one-component 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® NuGrip® 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. FDA UDI
Model / Reference
NUG44330M FDA UDI
Description
The Ascension® NuGrip® is an uncemented, one-component 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® NuGrip® 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. FDA UDI

Identifiers

Catalog Number
NUG-443-30M FDA UDI
Primary DI / UDI-DI
10381780120100 FDA UDI
510(k) Number
K112278 FDA UDI
FDA Product Code
KYI FDA UDI
GMDN Term
Metacarpal prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Metacarpal prosthesis

Ascension® NuGrip® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metacarpal prosthesis.

Cleared under the same submission

K112278 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 01242538-9664-46eb-8550-348d4c3785c4 38 fields · synced Jun 8, 2026