FDA.reportPublic FDA data

Optimotion Blue CR HCCR Total Knee System

Primary DI
B6961014L3421
Brand
Optimotion Blue CR HCCR Total Knee System
Company
OPTIMOTION IMPLANTS LLC
Model
1014-L-3421
Device description
TIBIAL INSERT HP PS SZ 4, 21 MM
Published
2024-09-11
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
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191084000The Optimotion Blue Total Knee SystemOptimotion Implants, LLC2020-04-07MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6961014L3421PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cruciate-retaining total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-678-6686support@optimotionimplants.com

Regulatory Flags#

DUNS number
056559377
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6961014F32000Optimotion Blue CR HCCR Total Knee System1014-F-32002026-01-07
B6961014F33000Optimotion Blue CR HCCR Total Knee System1014-F-33002026-01-07
B6961014F34000Optimotion Blue CR HCCR Total Knee System1014-F-34002026-01-07
B6961014F35000Optimotion Blue CR HCCR Total Knee System1014-F-35002026-01-07
B6961014F36000Optimotion Blue CR HCCR Total Knee System1014-F-36002026-01-07
B6961014F37000Optimotion Blue CR HCCR Total Knee System1014-F-37002026-01-07
B6961014F38000Optimotion Blue CR HCCR Total Knee System1014-F-38002026-01-07
B6961014L3109Optimotion Blue CR HCCR Total Knee System1014-L-31092024-09-11
B6961014L3111Optimotion Blue CR HCCR Total Knee System1014-L-31112024-09-11
B6961014L3113Optimotion Blue CR HCCR Total Knee System1014-L-31132024-09-11
B6961014L3115Optimotion Blue CR HCCR Total Knee System1014-L-31152024-09-11
B6961014L3117Optimotion Blue CR HCCR Total Knee System1014-L-31172024-09-11
B6961014L3119Optimotion Blue CR HCCR Total Knee System1014-L-31192024-09-11
B6961014L3121Optimotion Blue CR HCCR Total Knee System1014-L-31212024-09-11
B6961014L3209Optimotion Blue CR HCCR Total Knee System1014-L-32092024-09-11
B6961014L3211Optimotion Blue CR HCCR Total Knee System1014-L-32112024-09-11
B6961014L3213Optimotion Blue CR HCCR Total Knee System1014-L-32132024-09-11
B6961014L3215Optimotion Blue CR HCCR Total Knee System1014-L-32152024-09-11
B6961014L3217Optimotion Blue CR HCCR Total Knee System1014-L-32172024-09-11
B6961014L3219Optimotion Blue CR HCCR Total Knee System1014-L-32192024-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017269726EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269733EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269740EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269757EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269764EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269771EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269788EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269795EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017260853EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260860EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260877EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260884EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260891EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260907EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260914EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260921EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260938EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260945EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260952EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260969EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260976EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260983EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260990EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261003EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261010EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261027EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261034EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261041EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10