FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719886911626
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
2803-6253-RC
Catalog number
2803-6253-RC
Device description
Tibial augment trial, #5, 15mm, right
Published
2026-02-24
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122183000AUGMENT AND SCREW, PSA TYPEUnited Orthopedic Corp.2013-02-05JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719886911626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719886911626047198869116264719886911626

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA copy of a final tibia 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 femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin 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
DM exempt
true
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
04719886912524Locking Cage9208-8110-RA9208-8110-RA2026-03-03
04719886912951Locking Cage1308-2150-RA1308-2150-RA2026-03-03
04719886912968Locking Cage1308-2154-RA1308-2154-RA2026-03-03
04719886912975Locking Cage1308-2158-RA1308-2158-RA2026-03-03
04719886912982Locking Cage1308-2162-RA1308-2162-RA2026-03-03
04719886912999Locking Cage1308-2166-RA1308-2166-RA2026-03-03
04719886913002Locking Cage1308-2170-RA1308-2170-RA2026-03-03
04719886913019Locking Cage1308-2250-RA1308-2250-RA2026-03-03
04719886913026Locking Cage1308-2254-RA1308-2254-RA2026-03-03
04719886913033Locking Cage1308-2258-RA1308-2258-RA2026-03-03
04719886913040Locking Cage1308-2262-RA1308-2262-RA2026-03-03
04719886913057Locking Cage1308-2266-RA1308-2266-RA2026-03-03
04719886913064Locking Cage1308-2270-RA1308-2270-RA2026-03-03
04719886913071U-Motion II9206-8110-RA9206-8110-RA2026-03-03
04719886912005U2 Total Knee System2603-6313-RC2603-6313-RC2026-03-02
04719886912012U2 Total Knee System2603-6323-RC2603-6323-RC2026-03-02
04719886912029U2 Total Knee System2603-6333-RC2603-6333-RC2026-03-02
04719886912036U2 Total Knee System2603-6343-RC2603-6343-RC2026-03-02
04719886912043U2 Total Knee System2603-6353-RC2603-6353-RC2026-03-02
04719886912050U2 Total Knee System2603-6363-RC2603-6363-RC2026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262192EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262208EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262215EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262222EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262239EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262246EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262253EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262260EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262277EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262284EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262291EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262307EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262314EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262321EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262338EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262345EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262352EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262369EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262376EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262383EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262390EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262406EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262413EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262420EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262437EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262444EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262451EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10