FDA.reportPublic FDA data

OvertureTi

Primary DI
00810129550221
Brand
OvertureTi
Company
Overture Orthopaedics
Model
PKG-90-OVR-350017
Published
2024-12-06
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

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242746000OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics2024-10-07HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810129550221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810129550221008101295502218101295502210810129550221

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width17.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119105665
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810129551198OvertureTi90-OVR-5700172023-10-25
00810129551211OvertureTi90-OVR-5700222023-10-25
00810129551389OvertureTi90-OVR-6400172023-10-25
00810129551846OvertureTi90-S01-1022502025-07-23
00810129551723OvertureTiPKG-90-OSP-1017302025-03-14
00810129551730OvertureTiPKG-90-OSP-1020352025-03-14
00810129551747OvertureTiPKG-90-OSP-1022402025-03-14
00810129551754OvertureTiPKG-90-OSP-2000172025-03-14
00810129551761OvertureTiPKG-90-OSP-2000222025-03-14
00810129551778OvertureTiPKG-90-OSP-2000252025-03-14
00810129551785OvertureTiPKG-90-OSP-3600172025-03-14
00810129551792OvertureTiPKG-90-OSP-3600202025-03-14
00810129551808OvertureTiPKG-90-OSP-3600222025-03-14
00810129551815OvertureTiPKG-90-OSP-4000002025-03-14
00810129550238OvertureTiPKG-90-OVR-3500202024-12-06
00810129550245OvertureTiPKG-90-OVR-3500222024-12-06
00810129550467OvertureTi90-OVR-5100172023-10-25
00810129550481OvertureTi90-OVR-5100222023-10-25
00810129550498OvertureTi90-OVR-5100252023-10-25
00810129550528OvertureTi90-OVR-5117302023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
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
07613327127423INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
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
00888867106697Arthrex®ARTHREX, INC.HSX2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24