Integra® External Fixation System

Basic Information

• Brand Name: Integra® External Fixation System
• Primary DI: 10381780125419
• Version / Model: 12225210
• Catalog Number: 12225210
• 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: 4
• Public Version Date: 2023-05-02
• Public Version Status: Update
• Public Device Record Key: 1cc8c922-2964-4cc0-a481-6c327a1ae278
• Distribution End Date: 2023-03-31

Device Description

The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features one distal end which is designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.

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: 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
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35647	External orthopaedic fixation system, reusable	An assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780125419	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140463	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Medium: 140 - 180mm L