FDA.report

FREEDOM KNEE

Primary DI
00811767020152
Brand
FREEDOM KNEE
Company
MAXX ORTHOPEDICS, INC.
Model
UFPSRH00-K
Device description
FEMORAL, PS, RIGHT, H
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811767020152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767020152008117670201528117670201520811767020152

GMDN Terms

TermDefinition
Posterior-stabilized total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate ligament is sacrificed and uses a “cam and post” mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration.

Device Sizes

TypeValueUnit
Width80Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
792030103
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840333905487LibertasMO-CCND-37/222025-08-12
00840333909201LibertasMO-COND-37/222025-08-07
00840333909218LibertasMO-COND-38/222025-08-07
00840333909225LibertasMO-COND-39/222025-08-07
00840333909232LibertasMO-COND-40/222025-08-07
00840333909249LibertasMO-COND-40/282025-08-07
00840333909256LibertasMO-COND-41/222025-08-07
00840333909263LibertasMO-COND-41/282025-08-07
00840333909270LibertasMO-COND-42/222025-08-07
00840333909287LibertasMO-COND-42/282025-08-07
00840333909294LibertasMO-COND-43/222025-08-07
00840333909300LibertasMO-COND-43/282025-08-07
00840333909317LibertasMO-COND-44/222025-08-07
00840333909324LibertasMO-COND-44/282025-08-07
00840333909331LibertasMO-COND-45/282025-08-07
00840333909348LibertasMO-COND-46/282025-08-07
00840333909355LibertasMO-COND-46/322025-08-07
00840333909362LibertasMO-COND-47/282025-08-07
00840333909379LibertasMO-COND-47/322025-08-07
00840333909386LibertasMO-COND-48/282025-08-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889024706774Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706781Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706798Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706804Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00843575127143MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127150MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127167MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127174MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127181MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127198MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127204MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127211MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127228MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127235MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127242MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127259MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127266MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127273MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127280MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127297MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127303MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127310MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127327MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127334MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127341MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127358MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127365MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127372MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127389MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06