FDA.reportPublic FDA data

Engage Partial Knee System

Primary DI
B6951501004550
Brand
Engage Partial Knee System
Company
Engage UNI LLC
Model
1-50100-455
Device description
3.2MM Threaded Pin 55MM Pin w/ Collar 4/Pk
Published
2020-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B6951501004550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, non-sterileA small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device intended to be sterilized prior to use.

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
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
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00885556779989VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVHSX2018-10-17
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
00888867106697Arthrex®ARTHREX, INC.HSX2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327207163INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
00848486016401MakoMAKO SURGICAL CORP.HSX2015-11-04
00848486016401MakoMAKO SURGICAL CORP.NJD2015-11-04
00848486016418MakoMAKO SURGICAL CORP.NJD2015-11-04