FDA.reportPublic FDA data

FREEDOM PCK

Primary DI
00811767024136
Brand
FREEDOM PCK
Company
MAXX ORTHOPEDICS, INC.
Model
RLPSXG720-RK
Device description
Tibial Liner PCK, Size G7-8
Published
2015-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131481000FREEDOM PCK COMPONENTSMaxx Orthopedics, Inc.2014-02-21JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811767024136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767024136008117670241368117670241360811767024136

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, polyethyleneAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made entirely of polyethylene (PE) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
792030103
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810008128749LibertasMO-SFCC-28/062025-07-31
00810008128756LibertasMO-SFCC-28/072025-07-31
00810008128763LibertasMO-SFCC-28/082025-07-31
00810008128770LibertasMO-SFCC-28/092025-07-31
00810008128787LibertasMO-SFCC-28/102025-07-31
00810008128794LibertasMO-SFCC-28/112025-07-31
00810008128800LibertasMO-SFCC-28/122025-07-31
00810008128817LibertasMO-SFCC-28/132025-07-31
00810008128824LibertasMO-SFCC-28/142025-07-31
00810008128831LibertasMO-SFCC-28/152025-07-31
00810008128848LibertasMO-SFCC-28/162025-07-31
00810008128855LibertasMO-SFCC-28/172025-07-31
00810008128862LibertasMO-SFCC-28/182025-07-31
00810008128879LibertasMO-SFCC-28/202025-07-31
00810008128886LibertasMO-SFCC-28/222025-07-31
00810008128893LibertasMO-SFCC-28/242025-07-31
00810008129081LibertasMO-SFCC-32/042025-07-31
00810008129098LibertasMO-SFCC-32/052025-07-31
00810008129104LibertasMO-SFCC-32/062025-07-31
00810008129111LibertasMO-SFCC-32/072025-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017269726EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269733EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269740EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269757EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269764EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269771EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269788EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269795EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017260853EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260860EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260877EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260884EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260891EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260907EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260914EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260921EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260938EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260945EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260952EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260969EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260976EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260983EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260990EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261003EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261010EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261027EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261034EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261041EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10