FDA.reportPublic FDA data

Freedom

Primary DI
00811767028394
Brand
Freedom
Company
MAXX ORTHOPEDICS, INC.
Model
MLUCXD116-K
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182574000Freedom Ultra-Congruent CR Tibial LinerMaxx Orthopedics, Inc.2019-01-22JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811767028394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767028394008117670283948117670283940811767028394

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

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
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00840333926413Freedom Metaphyseal ConeRTCOX2530-RKRTCOX2530-RK2026-09-21
00840333926420Freedom Metaphyseal ConeRTCOX3030-RKRTCOX3030-RK2026-09-21
00840333926437Freedom Metaphyseal ConeRTCOX3530-RKRTCOX3530-RK2026-09-21
00840333926444Freedom Metaphyseal ConeRTCOX4030-RKRTCOX4030-RK2026-09-21
00840333926451Freedom Metaphyseal ConeRTCOX4530-RKRTCOX4530-RK2026-09-21
00840333926468Freedom Metaphyseal ConeRTCOX5030-RKRTCOX5030-RK2026-09-21
00840333926475Freedom Metaphyseal ConeRTCOX5530-RKRTCOX5530-RK2026-09-21
00840333926482Freedom Metaphyseal ConeRTCOX6030-RKRTCOX6030-RK2026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20