FDA.reportPublic FDA data

Coated Revision Stem

Primary DI
B046220811101500
Brand
Coated Revision Stem
Company
SIGNAL MEDICAL CORPORATION
Model
10x150
Catalog number
22-08-1110150
Device description
10x150 Coated Revision Stem
Published
2021-08-18
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
K100370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100370000SYMMETRIC TOTAL KNEE AGUMENTSSignal Medical Corp.2011-03-07JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B046220811101500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sleeve femoral/tibial extension, coatedA sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8103647070vfowler@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
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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