FDA.reportPublic FDA data

TRIVANCE

Primary DI
00193982895525
Brand
TRIVANCE
Company
GLOBUS MEDICAL, INC.
Model
4270.1010S
Catalog number
4270.1010S
Device description
TRIVANCE Distal Centralizer, 10mm
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQHHip, semi-constrained, cemented, metal/polymer + additive, cemented
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
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254043000TRIVANCE™ Hip StemGlobus Medical, Inc.2026-08-04LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982895525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982895525001939828955251939828955250193982895525

GMDN Terms#

Term, Definition table
TermDefinition
Metal-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25
00889095411263ANTHEM7171.55097171.55092026-09-25
00889095411287ANTHEM7171.55117171.55112026-09-25
00889095411300ANTHEM7171.55137171.55132026-09-25
00889095411324ANTHEM7171.55157171.55152026-09-25
00889095611274ANTHEM2171.65852171.65852026-09-25
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707160G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.OQI2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.OQH2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCOQI2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCOQH2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.OQH2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.OQI2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCOQI2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCOQH2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.OQI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.OQH2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCOQH2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCOQI2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30