FDA.reportPublic FDA data

GMK Sphere Cementless

Primary DI
07630345799104
Brand
GMK Sphere Cementless
Company
Medacta International SA
Model
02.12.1505R
Device description
GMK Sphere Femur Porous TiGrowthC+HA S5R
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
07630345799104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345799104076303457991047630345799104

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
07630542720680Surgical Manual Instrument03.22.10.10572026-10-14
07630542720895Surgical Manual Instrument03.22.10.11122026-10-14
07630542721045Surgical Manual Instrument03.22.10.11142026-10-14
07630542721052Surgical Manual Instrument03.22.10.11172026-10-14
07630542721069Surgical Manual Instrument03.22.10.11182026-10-14
07630542721304Surgical Manual Instrument03.22.10.12422026-10-14
07630542721311Surgical Manual Instrument03.22.10.12432026-10-14
07630542721335Surgical Manual Instrument03.22.10.13422026-10-14
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20