FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719886908015
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
2823-2252
Catalog number
2823-2252
Device description
Tibial augment trial, #5, 10mm, right
Published
2025-07-11
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
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
KWLProsthesis, Hip, Hemi-, Femoral, Metal
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190100000USTAR II SystemUnited Orthopedic Corporation2019-09-23KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719886908015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719886908015047198869080154719886908015

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trial, reusableA copy of a final femur 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. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886229294567tw.service@unitedorthopedic.com

Regulatory Flags#

DUNS number
656700556
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719886896466United Hip System1209-12421209-12422026-09-24
04719886896473United Hip System1209-12441209-12442026-09-24
04719886896480United Hip System1209-12481209-12482026-09-24
04719886896497United Hip System1209-12521209-12522026-09-24
04719886896503United Hip System1209-12541209-12542026-09-24
04719886896510United Hip System1209-12581209-12582026-09-24
04719886896527United Hip System1209-12621209-12622026-09-24
04719886896534United Hip System1209-12661209-12662026-09-24
04719886896541United Hip System1209-18481209-18482026-09-24
04719886896558United Hip System1209-18521209-18522026-09-24
04719886896565United Hip System1209-18541209-18542026-09-24
04719886896572United Hip System1209-18581209-18582026-09-24
04719886896589United Hip System1209-18621209-18622026-09-24
04719886896596United Hip System1209-18661209-18662026-09-24
04719886896633United Hip System1309-10461309-10462026-09-24
04719886896640United Hip System1309-10481309-10482026-09-24
04719886896657United Hip System1309-10501309-10502026-09-24
04719886896664United Hip System1309-10521309-10522026-09-24
04719886896671United Hip System1309-10541309-10542026-09-24
04719886896688United Hip System1309-10561309-10562026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24