Monster Screw System

Basic Information

• Brand Name: Monster Screw System
• Primary DI: 00889795153234
• Version / Model: P99-192-1110
• Catalog Number: P99-192-1110
• Company Name: Paragon 28, Inc.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-10-17
• Public Version: 5
• Public Version Date: 2025-11-19
• Public Version Status: Update
• Public Device Record Key: c9812b38-2afe-4dab-bc6b-284c1b0d970c

Device Description

K-Wire, Single Ended Trocar Tip, Smooth, 1.1 x 100mm

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HXI	PASSER, WIRE, ORTHOPEDIC	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795153234	GS1
Unit of Use	70889795153233	GS1