FDA.reportPublic FDA data

TRIVANCE

Primary DI
00193982895303
Brand
TRIVANCE
Company
GLOBUS MEDICAL, INC.
Model
1270.2105S
Catalog number
1270.2105S
Device description
TRIVANCE Hip Stem, Press-Fit, Lateral, Collarless, Size 5
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
00193982895303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982895303001939828953031939828953030193982895303

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device 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 is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00889095205831XEMPLIFI8103.0001S2015-10-10
00889095205848XEMPLIFI8103.0005S2015-10-10
00889095205855XEMPLIFI8103.0010S2015-10-10
00889095205862XEMPLIFI8103.0101S2015-10-10
00889095205879XEMPLIFI8103.0105S2015-10-10
00889095205886XEMPLIFI8103.0110S2015-10-10
00889095205893XEMPLIFI8103.0201S2015-10-10
00889095205909XEMPLIFI8103.0203S2015-10-10
00889095205916XEMPLIFI8103.0208S2015-10-10
00889095205923XEMPLIFI8103.0210S2015-10-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15