FDA.reportPublic FDA data

FREEDOM PARTIAL KNEE

Primary DI
00811767025539
Brand
FREEDOM PARTIAL KNEE
Company
MAXX ORTHOPEDICS, INC.
Model
311328
Device description
PARTIAL ALL POLY TIBIAL, SMALL
Published
2016-02-29
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
K072704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072704000UNICOMPARTMENTAL KNEEValpo Orthopedic Technology, Inc.2008-02-19HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811767025539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767025539008117670255398117670255390811767025539

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8.5Millimeter

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
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29
03701089518406TRAXAMPLITUDE SASJWH2026-07-29
03701089518413TRAXAMPLITUDE SASJWH2026-07-29
03701089518420TRAXAMPLITUDE SASJWH2026-07-29
03701089518437TRAXAMPLITUDE SASJWH2026-07-29
03701089518444TRAXAMPLITUDE SASJWH2026-07-29