FDA.reportPublic FDA data

GMK Sphere Cementless

Primary DI
07630345799043
Brand
GMK Sphere Cementless
Company
Medacta International SA
Model
02.12.1502R
Device description
GMK Sphere Femur Porous TiGrowthC+HA S2R
Published
2023-01-23
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

Product Codes#

Code, Name table
CodeName
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223548000GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.2023-01-20MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345799043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345799043076303457990437630345799043

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee femur prosthesisA sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation may be performed with or without bone cement.

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630345729316NextAR TSA Platform5.3SSWNXAR2026-04-13
07630345728975Navigation System for Knee surgery33.22.10002026-01-26
07630699701792Navigation System for Knee surgery33.22.1000US2026-01-26
07630345725912NextAR Spine Platform98.46.NEXTAR2026-01-20
07630542722332NextAR Hip Platform09.23.10.IMU2026-01-14
07630542779626NextAR Hip Platform5.3HSWNXAR2026-01-14
07630542759130NextAR™ Spine03.57.10.02622025-11-14
07630542759147NextAR™ Spine03.57.10.02632025-11-14
07630542720390NextAR Spine Platform03.57.10.02032025-09-19
07630542720406NextAR Spine Platform03.57.10.02042025-09-19
07630542720413NextAR Spine Platform03.57.10.02052025-09-19
07630542720420NextAR Spine Platform03.57.10.02062025-09-19
07630542720437NextAR Spine Platform03.57.10.02072025-09-19
07630542720444NextAR Spine Platform03.57.10.02082025-09-19
07630542720451NextAR Spine Platform03.57.10.02092025-09-19
07630542765346NextAR (TM) Shoulder Platform04.01.10.09022025-09-17
07630542765353NextAR (TM) Shoulder Platform04.01.10.09032025-09-17
07630542765360NextAR (TM) Shoulder Platform04.01.10.09042025-09-17
07630542765421NextAR (TM) Shoulder Platform04.01.10.09102025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298828ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298835ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298842ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298859ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298866ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298873ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298880ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298897ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298903ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298910ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298927ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298934ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298941ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298958ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298965ProphecyMicroport Orthopedics Inc.MBH2020-09-25