FDA.reportPublic FDA data

FREEDOM KNEE

Primary DI
00811767020046
Brand
FREEDOM KNEE
Company
MAXX ORTHOPEDICS, INC.
Model
UFPSLE00-K
Device description
FEMORAL, PS, LEFT, E
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

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811767020046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767020046008117670200468117670200460811767020046

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Width68Millimeter

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
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