FDA.reportPublic FDA data

BKS® Uni

Primary DI
00822409121007
Brand
BKS® Uni
Company
Ortho Development Corporation
Model
763-7091A
Device description
Tibial Insert Medial Left Size 7 9mm
Published
2023-08-25
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

Contact Domains#

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
K211471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211471000Balanced Knee System UniOrtho Development Corporation2021-12-16HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409121007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409121007008224091210078224091210070822409121007

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409082124N/A233-01382026-07-16
00822409082131N/A233-01392026-07-16
00822409082148N/A233-01402026-07-16
00822409082155N/A233-01412026-07-16
00822409082162N/A233-01422026-07-16
00822409082179N/A233-01432026-07-16
00822409082186N/A233-01442026-07-16
00822409082193N/A233-01452026-07-16
00822409082209N/A233-01462026-07-16
00822409082216N/A233-01472026-07-16
00822409082223N/A233-01482026-07-16
00822409082230N/A233-01492026-07-16
00822409082247N/A233-01502026-07-16
00822409082254N/A233-01512026-07-16
00822409082261N/A233-01522026-07-16
00822409082278N/A233-01532026-07-16
00822409082285N/A233-01542026-07-16
00822409082292N/A233-01552026-07-16
00822409082308N/A233-01562026-07-16
00822409082315N/A233-01572026-07-16

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