FDA.reportPublic FDA data

Engage Partial Knee System

Primary DI
B6951100136590
Brand
Engage Partial Knee System
Company
Engage UNI LLC
Model
1-10013-659
Device description
Tibial Insert, Size 6, Right Medial, 9MM
Published
2020-07-10
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
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190439000Engage™ Partial Knee SystemEngage Uni, LLC2019-11-21NJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6951100136590PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-364-2432info@engagesurgical.com
1-800-238-7538gudid@smith-nephew.com

Regulatory Flags#

DUNS number
088177182
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6951520010000Engage Partial Knee System1-52001-0002020-07-10
B6951520020000Engage Partial Knee System1-52002-0002020-07-10
B6951520040000Engage Partial Knee System1-52004-0002020-07-10
B6951520050000Engage Partial Knee System1-52005-0002020-07-10
B6951520100000Engage Partial Knee System1-52010-0002020-07-10
B6951500780000Engage Partial Knee System1-50078-0002021-04-09
B6951510040050Engage Partial Knee System1-51004-0052021-03-01
B6951510050050Engage Partial Knee System1-51005-0052021-03-01
B6951510380000Engage Partial Knee System1-51038-0002021-03-01
B6951510390000Engage Partial Knee System1-51039-0002021-03-01
B6951500600210Engage Partial Knee System1-50060-0212020-10-02
B6951100035000Engage Partial Knee System1-10003-5002020-07-10
B6951100131090Engage Partial Knee System1-10013-1092020-07-10
B6951100131100Engage Partial Knee System1-10013-1102020-07-10
B6951100131110Engage Partial Knee System1-10013-1112020-07-10
B6951100131130Engage Partial Knee System1-10013-1132020-07-10
B6951100132090Engage Partial Knee System1-10013-2092020-07-10
B6951100132100Engage Partial Knee System1-10013-2102020-07-10
B6951100132110Engage Partial Knee System1-10013-2112020-07-10
B6951100132130Engage Partial Knee System1-10013-2132020-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
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07613327127478INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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07613327051131INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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07613327051155INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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07613327051186INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24