Kompressor™ Compression Screw System

Basic Information

• Brand Name: Kompressor™ Compression Screw System
• Primary DI: 10381780065722
• Version / Model: 210316
• Catalog Number: 210316
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 7
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 1ee4f9c7-87c3-4826-8cfa-35da721ce307
• Distribution End Date: 2023-03-31

Device Description

The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.

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: Yes
• 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46646	Orthopaedic bone screw, non-bioabsorbable, sterile	A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2482103161	HIBCC
Primary	10381780065722	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040356	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.6 mm dia x 20 mm L; leading screw 16 mm L

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.