FDA.reportPublic FDA data

FREEDOM STEMMED

Primary DI
00811767024730
Brand
FREEDOM STEMMED
Company
MAXX ORTHOPEDICS, INC.
Model
RGPSDH00-RK
Device description
Distal Femoral Augment Size H
Published
2015-10-07
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
K111785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111785000FREEDOM(R) STEMMED TIBIAL COMPONENTSMaxx Orthopedics, Inc.2012-06-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811767024730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811767024730008117670247308117670247300811767024730

GMDN Terms#

Term, Definition table
TermDefinition
Bicompartmental knee prosthesisA sterile implantable device designed to replace the patellofemoral and medial tibiofemoral articulating surfaces of a damaged/degenerative (e.g., arthritic) knee during primary or revision bicompartmental replacement of the joint; it is intended to permit retention of the lateral tibiofemoral compartment and both cruciate ligaments. The device is made of metal [e.g., oxidized zirconium alloy, cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Width20.5Millimeter

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
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107626MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107633MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107640MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107657MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107664MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107671MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107688MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107718MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107725MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29