FDA.reportPublic FDA data

UniSyn Hip System

Primary DI
00840286836036
Brand
UniSyn Hip System
Company
Shalby Advanced Technologies, Inc.
Model
3426-11117-0
Catalog number
3426-11117-0
Device description
Stem, PLUS, Straight, Cementless, 11×170mm, Neutral
Published
2022-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286836036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286836036008402868360368402868360360840286836036

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined, and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286855648CS2 Acetabular System1905-1-00421905-1-00422025-09-22
00840286856676CS2 Acetabular System1904-2-28581904-2-28582025-09-22
00840286860024Consensus Knee System2800-0-20232800-0-20232025-07-07
00840286860031Consensus Knee System2800-0-20242800-0-20242025-07-07
00840286860079Consensus Knee System2800-0-20252800-0-20252025-07-07
00840286853132Consensus Knee System2800-0-20142800-0-20142025-06-04
00840286841016Bipolar Hip System55050-0055050-002025-05-22
00840286841023Bipolar Hip System1914-2-00001914-2-00002025-05-22
00840286841030Bipolar Hip System1814-0-42441814-0-42442025-05-22
00840286841047Bipolar Hip System1814-0-45471814-0-45472025-05-22
00840286841054Bipolar Hip System1814-0-48501814-0-48502025-05-22
00840286841061Bipolar Hip System1814-0-51531814-0-51532025-05-22
00840286841078Bipolar Hip System1814-0-54561814-0-54562025-05-22
00840286841085Bipolar Hip System1814-0-57591814-0-57592025-05-22
00840286841092Bipolar Hip System1814-0-60621814-0-60622025-05-22
00840286841108Bipolar Hip System1914-0-00421914-0-00422025-05-22
00840286841115Bipolar Hip System1914-0-00431914-0-00432025-05-22
00840286841122Bipolar Hip System1914-0-00441914-0-00442025-05-22
00840286841139Bipolar Hip System1914-0-00451914-0-00452025-05-22
00840286841146Bipolar Hip System1914-0-00461914-0-00462025-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862661012N/AExactech, Inc.JDI2026-03-19
10885862661166N/AExactech, Inc.JDI2026-03-19
10885862661173N/AExactech, Inc.JDI2026-03-19
10885862663221N/AExactech, Inc.JDI2026-03-19
04719886912524Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912951Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912968Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912975Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912982Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912999Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913002Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913019Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913026Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913033Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913040Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913064Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
00889024703292OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703315OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703339OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
10885862658210EXACTECHExactech, Inc.JDI2025-11-14
10885862658326EXACTECHExactech, Inc.JDI2025-11-14
04719872162568UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872162926UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169017UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169024UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169031UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
00810008120859LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120866LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120873LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120880LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23