Actua Knee Hydraulic CA603-PHY

GUDID 00850013242320

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.

CYPRESS ADAPTIVE, LLC

Polycentric mechanical knee prosthesis

• Primary Device ID: 00850013242320
• NIH Device Record Key: 98dd1145-7410-4585-bb6a-94db41cd8250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actua Knee Hydraulic
• Version Model Number: CA603-PHY
• Catalog Number: CA603-PHY
• Company DUNS: 080277500
• Company Name: CYPRESS ADAPTIVE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013242320 [Primary]

FDA Product Code

• ISY: Joint, Knee, External Limb Component

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

Devices Manufactured by CYPRESS ADAPTIVE, LLC

• 00850013242894 - Aria Universal Mini Valve Molding Dummy: 2023-10-13 Molding dummy is used to install the Aria Universal Mini Valve in a prosthesis socket
• 00850013242887 - Aria Universal Mini Valve Key: 2022-10-10 Tool to install or remove valves for prosthesis sockets
• 00850013242016 - Aria Mini Valve: 2021-11-25 Valve for installation into limb prosthesis with a small diameter and low profile.
• 00085001342106 - Aria Mini Valve: 2021-08-19 Valve for installation into limb prosthesis with a small diameter and low profile.
• 00850013242009 - Aria Valve (US): 2019-12-25 Auto Expulsion suction valve (US threads) for prosthetic sockets
• 00850013242023 - Aria valve (metric): 2019-12-25 Aria valve (metric threads) auto expulsion suction valve for prosthetic sockets.
• 00850013242030 - Aria Valve Plus (US): 2019-12-25 Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for suction suspension.
• 00850013242047 - Aria valve plus (metric): 2019-12-25 Aria valve (metric) auto expulsion suction valve for prosthetic sockets.