FDA.reportPublic FDA data

Consensus Hip System

Primary DI
00840286807821
Brand
Consensus Hip System
Company
Shalby Advanced Technologies, Inc.
Model
1410-0-0016
Catalog number
1410-0-0016
Device description
Femoral Stem, Collarless, Cementless, NP, HA Coated, 16
Published
2022-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286807821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286807821008402868078218402868078210840286807821

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103434POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103489POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103496POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103502POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103519POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103533POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103540POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996152692POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103373POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103380POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103397POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103403POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07613153071273RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MEH2015-09-24