FDA.reportPublic FDA data

Engage Partial Knee System

Primary DI
B6951500100020
Brand
Engage Partial Knee System
Company
Engage UNI LLC
Model
1-50010-002
Device description
Tibial Cutting Block +2MM Left Medial
Published
2020-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B6951500100020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
DM exempt
true
Lot or batch
true
Sterilization required before use
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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07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
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07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
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07613327051186INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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07613327051223INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24