Ascension® First Choice® DRUJ System

Basic Information

• Brand Name: Ascension® First Choice® DRUJ System
• Primary DI: 10381780123552
• Version / Model: DRUJ6101455WW
• Catalog Number: DRUJ6101455WW
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 5
• Public Version Date: 2023-02-22
• Public Version Status: Update
• Public Device Record Key: 2aa3bf0b-a9d0-4ecf-9e9b-ec0f8595530c
• Distribution End Date: 2026-12-31

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXE	PROSTHESIS, WRIST, HEMI-, ULNAR	Orthopedic	888.3810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33720	Wrist ulna-head prosthesis	A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780123552	GS1
Secondary	M268DRUJ6101455WW1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112481	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14.5 mm head; 5.5 mm stem