FDA.reportPublic FDA data

Actua Knee Pneumatic

Primary DI
00850013242313
Brand
Actua Knee Pneumatic
Company
CYPRESS ADAPTIVE, LLC
Model
CA603-PPN
Catalog number
CA603-PPN
Device 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.
Published
2019-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISYJoint, Knee, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISYJoint, Knee, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013242313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013242313008500132423138500132423130850013242313

GMDN Terms#

Term, Definition table
TermDefinition
Polycentric mechanical knee prosthesisAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080277500
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013242092Aria safety barb (US)CA300-ASBCA300-ASB2019-12-17
00850013242108Aria Safety Barb (metric)CA300-ASBMCA300-ASBM2019-12-17
00850013242894Aria Universal Mini Valve Molding DummyCA100-MVDCA100-MVD2023-10-05
00850013242887Aria Universal Mini Valve KeyCA100-MVK2022-10-01
00850013242016Aria Mini ValveCA100-MVCA100-MV2021-08-11
00085001342106Aria Mini ValveCA100-MVCA100-MV2021-08-11
00850013242009Aria Valve (US)CA200-AVCA200-AV2019-12-17
00850013242023Aria valve (metric)CA200-AVMCA200-AVM2019-12-17
00850013242030Aria Valve Plus (US)CA200-AVPCA200-AVP2019-12-17
00850013242047Aria valve plus (metric)CA200AVPMCA200AVPM2019-12-17
00850013242054Aria E-valveCA200-AECA200-AE2019-12-17
00850013242061Aria plate valveCA300-APVCA300-APV2019-12-17
00850013242078Aria HV Plate Valve CA300-AHVPCA300-AHVP2019-12-17
00850013242085Aria Hybrid ValveCA300-HYVCA300-HYV2019-12-17
00850013242115Aria AK ValveCA100-AKCA100-AK2019-12-17
00850013242122Aria AK valve insertCA100-VICA100-VI2019-12-17
00850013242139Cypress 4-hole tie-in plateCA400-TIPCA400-TIP2019-12-17
00850013242146Cypress low profile 4-hole tie-in plateCA400-LPCA400-LP2019-12-17
00850013242153Aria auto expulsion valve insertCA400-VCA400-V2019-12-17
00850013242160Aria HV Valve insert CA400-HVCA400-HV2019-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186936Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00841747186943Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00195411458905IconCOLLEGE PARK INDUSTRIES, INC.ISY2025-05-28
00194711121014IntuyWillowwood Global LLCISY2025-03-21
00194711121021IntuyWillowwood Global LLCISY2025-03-21
00713980034377BIOSTEP XTAlps South, LLCISY2025-01-14
04719883460356TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
04719883460370TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
00195411458820IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458837IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458844IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458851IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458868IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00841747186707AuraCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
04719883460004TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460028TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460035TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460059TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460066TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460073TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460103TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460110TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460158TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460264TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460271TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460288TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460301TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460318TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460325TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460332TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31