FDA.reportPublic FDA data

Consensus Knee System

Primary DI
00840286846455
Brand
Consensus Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2967-0-1001
Catalog number
2967-0-1001
Device description
Patella, Oval, Trial, UHMWPE, 7.5mm, Sz 1
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286846455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286846455008402868464558402868464550840286846455

GMDN Terms#

Term, Definition table
TermDefinition
Patella prosthesis trialA copy of a final patella prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis, and to check that patellar ligament balancing is correct. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

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G791EFTEMPS080WishFIXRed Star Contract Manufacturing Inc.HWT2025-10-06
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
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09348215085001Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085018Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
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09348215085032Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
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09348215085094Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085100Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085117Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20