FDA.reportPublic FDA data

Symmetric Total Knee Tibial Tray

Primary DI
B04622021230
Brand
Symmetric Total Knee Tibial Tray
Company
SIGNAL MEDICAL CORPORATION
Model
Size: 3
Catalog number
22-02-123
Device description
Symmetric Total Knee Tibial Tray Size: 3
Published
2016-03-24
Public version status
Update
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
K080199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080199000SYMMETRIC TOTAL KNEE SYSTEMSignal Medical Corporation2008-07-03JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B04622021230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated unicondylar knee tibia prosthesisA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. 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 articulates with a femoral component and an insert, and its implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
810-364-7070jgorney@signalmd.com

Regulatory Flags#

DUNS number
169289308
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B046BIO110830PCL RetractorN/ABIO-1-10832023-02-21
B046BIO11081Femoral BeltN/ABIO-1-10812022-06-17
B046BIO11082Tibial BeltN/ABIO-1-10822022-05-12
B046BIO110840Lateral RetractorN/ABIO-1-10842022-05-12
B046BIO110350Gel Pad"46"""BIO-1-10352022-02-10
B046BIO110210Slide BlockBIO-1-1021BIO-1-10212021-10-22
B046BIO110220Boot AssemblyBIO-1-1022BIO-1-10222021-10-22
B046BIO110240End StopBIO-1-1024BIO-1-10242021-10-22
B046BIO11012A0Low Profile Cable1.5mm CableBIO-1-1012-A2021-08-26
B046BIO110120CoCr Low Profile Cable System1.5mm CableBIO110122016-01-12
B046WF110010Cancellous Bone Screw15mmWF-1-10012016-08-05
B046WF110020Cancellous Bone Screw20mmWF-1-10022016-01-07
B046WF110030Cancellous Bone Screw25mmWF-1-10032016-02-12
B046WF110040Cancellous Bone Screw30mmWF-1-10042016-01-07
B046WF110050Cancellous Bone Screw35mmWF-1-10052015-12-16
B046WF110060Cancellous Bone Screws40mmWF-1-10062015-12-16
B046WF110070Cancellous Bone Screw45mmWF-1-10072019-03-22
B046WF110080Cancellous Bone Screw50mmWF-1-10082019-03-22
B046BIO110930Straight Osteotome"1/2"""BIO-1-10932023-04-24
B046BIO110440Knee OsteogatorN/ABIO-1-10442023-03-14

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