Ascension® First Choice® DRUJ System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Ascension® First Choice® DRUJ System FDA UDI
Generic Name: Wrist ulna-head prosthesis FDA UDI
Device Name: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ulnar head replacement. It has a distal articular head and proximal intramedullary stem. The cobalt chromium implant head articulates with the radius and the carpal bones of the wrist. These features match native ulnar head articulation. The implant is inserted into the medullary canal of the ulna following resection of the ulnar head. It is designed to be a press fit device that achieves fixation by means of direct implant/bone appositions. FDA UDI
Model / Reference: DRUJ6101955WW FDA UDI
Description: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ulnar head replacement. It has a distal articular head and proximal intramedullary stem. The cobalt chromium implant head articulates with the radius and the carpal bones of the wrist. These features match native ulnar head articulation. The implant is inserted into the medullary canal of the ulna following resection of the ulnar head. It is designed to be a press fit device that achieves fixation by means of direct implant/bone appositions. FDA UDI

Identifiers

Catalog Number: DRUJ6101955WW FDA UDI
Primary DI / UDI-DI: 10381780123644 FDA UDI
510(k) Number: K112481 FDA UDI
FDA Product Code: KXE FDA UDI
GMDN Term: Wrist ulna-head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3810 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Wrist ulna-head prosthesis

Ascension® First Choice® DRUJ System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wrist ulna-head prosthesis.

BioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc. · Class II
First Choice Modular Ulnar Head Implant — Smith & Nephew, Inc. · Class II
UHEAD — Stryker Corp. · Class II
Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc. · Class II
Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc. · Class II
UHEAD — Stryker Corp. · Class II
Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc. · Class II
Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc. · Class II

Cleared under the same submission

K112481 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 4ec366e1-4536-4fa4-aa6e-ce85b2b6e3b6 38 fields · synced May 31, 2026