FDA.reportPublic FDA data

ENGAGE

Primary DI
00885556873939
Brand
ENGAGE
Company
Smith & Nephew, Inc.
Model
1-10013-561
Catalog number
1-10013-561
Device description
ENGAGE TIBIAL INSERT SIZE 5-RIGHT MED 11MM
Published
2023-01-11
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
K230653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190439000Engage™ Partial Knee SystemEngage Uni, LLC2019-11-21NJD
K230653000Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial BaseplatesSmith & Nephew, Inc.2023-05-04JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556873939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556873939008855568739398855568739390885556873939

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
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

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
07613327051155INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
00848486016401MakoMAKO SURGICAL CORP.HSX2015-11-04