FDA.reportPublic FDA data

FREEDOM STEMMED

Primary DI
00811767024662
Brand
FREEDOM STEMMED
Company
MAXX ORTHOPEDICS, INC.
Model
RGPSDA00-RK
Device description
Distal Femoral Augment Size A
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00811767024662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767024662008117670246628117670246620811767024662

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular augmentation implantA sterile implantable device intended to help prevent dislocation of a total hip replacement by augmenting the posterior lip of the acetabulum around a retained acetabular prosthesis, or to help fill bone defects not covered by the acetabular prosthesis. It is designed to help constrain the femoral head and/or provide additional support for the acetabular prosthesis. It is available in various shapes, is typically made of metal [e.g. Titanium alloy] and/or polymer, and may be fixed with screws and/or cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(484) 342-0096don.guthner@maxxortho.com

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
00811767028394FreedomMLUCXD116-K2026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24