FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719886892864
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
2303-2274-RK
Catalog number
2303-2274-RK
Device description
Tibial insert trial, #7, 15mm
Published
2023-02-20
Public version status
Update
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
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131864000
K221705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131864000U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTUnited Orthopedic Corporation2014-01-15JWH
K221705000U2 Total Knee System-PF+United Orthopedic Corporation2023-02-28MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719886892864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719886892864047198868928644719886892864

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
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
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.MBH2026-08-14