FDA.reportPublic FDA data

U-Motion II™

Primary DI
04719872162070
Brand
U-Motion II™
Company
UNITED ORTHOPEDIC CORP.
Model
1406-6656
Catalog number
1406-6656
Device description
U-Motion II Acetabular liner trial, 20°, ID36mm, OD56mm
Published
2017-05-19
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
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122185000
K172833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122185000U-MOTION II ACETABULAR SYSTEMUnited Orthopedic Corp.2013-02-22LZO
K172833000E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018-06-12OQI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872162070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872162070047198721620704719872162070

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. 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
+886229294567service@uoc.com.tw

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
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
00889024707160G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.OQI2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCOQI2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.OQI2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCOQI2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.OQI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCOQI2026-09-30
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-24
07613327380392TRIDENT IIHowmedica Osteonics Corp.LZO2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.MEH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.JDI2018-02-12
07613327345001Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.MEH2016-10-20