Actua Knee Pneumatic CA603-PPN

GUDID 00850013242313

The Actua Knee is a polycentric pneumatic knee joint with stance flexion feature and non-adjustable spring extension assist. The stance flexion can be tuned infinitely, which ensures optimal comfort during loading response. The particularly long steering knuckles ensure high stability as well as a high flexion angle of the knee-joint.

CYPRESS ADAPTIVE, LLC

Polycentric mechanical knee prosthesis

• Primary Device ID: 00850013242313
• NIH Device Record Key: 39acc087-5b1b-4bcb-9d16-ca9d080893bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actua Knee Pneumatic
• Version Model Number: CA603-PPN
• Catalog Number: CA603-PPN
• 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	00850013242313 [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.