K-WIRE

Basic Information

• Brand Name: K-WIRE
• Primary DI: 10381780045786
• Version / Model: 115170ND
• Catalog Number: 115170ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 3dd35b3e-d879-4318-a04c-69ac565f1506
• Distribution End Date: 2026-06-30

Device Description

The NEWDEAL K-WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion. They are made out of stainless steel and are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants.

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: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35685	Orthopaedic bone wire	A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780045786	GS1
Secondary	M248115170ND1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K022599	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.0mm diam. x 70mm length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place