Identity
- Trade Name
- Actua Knee Pneumatic FDA UDI
- Generic Name
- Polycentric mechanical knee prosthesis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CA603-PPN FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- CA603-PPN FDA UDI
- Primary DI / UDI-DI
- 00850013242313 FDA UDI
- FDA Product Code
- ISY FDA UDI
- GMDN Term
- Polycentric mechanical knee prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polycentric mechanical knee prosthesis
Actua Knee Pneumatic by Cypress Adaptive, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polycentric mechanical knee prosthesis.
- Actua Knee Hydraulic — CYPRESS ADAPTIVE, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cypress Adaptive, Llc
Sources (1)
- FDA UDI 39acc087-5b1b-4bcb-9d16-ca9d080893bc 34 fields · synced Jun 1, 2026