Actua Knee Hydraulic

Basic Information

• Brand Name: Actua Knee Hydraulic
• Primary DI: 00850013242320
• Version / Model: CA603-PHY
• Catalog Number: CA603-PHY
• Company Name: CYPRESS ADAPTIVE, LLC
• Labeler DUNS: 080277500
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-02
• Public Version: 1
• Public Version Date: 2019-12-10
• Public Version Status: New
• Public Device Record Key: 98dd1145-7410-4585-bb6a-94db41cd8250

Device Description

The Actua Knee Hydraulic is a polycentric hydraulic knee joint with stance flexion feature and interchangeable spring extension assist. The stance flexion can be tuned infinitely, which ensures optimal comfort during loading response. The patented horizontal hydraulic cylinder contributes to the compact size of this hydraulic knee joint. In addition, maintenance is easy with the innovative oil-refill system.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISY	Joint, Knee, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43795	Polycentric mechanical knee prosthesis	An artificial substitute for a transfemoral (above-the-knee) and/or knee disarticulation amputation designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It typically consists of metal and plastic and is constructed as a multiple-axis joint rotation, mechanical hinge that incorporates friction adjustment and a simple swing control that permits variable walking speed. A common design, known as a “fourbar” knee, is very stable during early stance phase (beginning of a step), reduces the leg’s length when beginning a step lowering the risk of stumbling, and bends in the swing phase or when the user sits down.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013242320	GS1