FDA.reportPublic FDA data

MicroPort

Primary DI
M684260136XSWD1
Brand
MicroPort
Company
Microport Orthopedics Inc.
Model
260136XSWD
Catalog number
260136XSWD
Published
2019-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190123000MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.2019-07-15LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M684260136XSWD1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629031999Lineage26010010260100102026-08-18
00192629032064Lineage26012804260128042026-08-18
00192629032071Lineage26012805260128052026-08-18
00192629080515MICROPORT26010011260100112026-08-18
00192629176553MICROPORT260136XX260136XX2026-08-18
00192629031937Lineage26010002260100022026-08-17
00192629031951MICROPORT26010006260100062026-08-17
00192629031968Lineage26010007260100072026-08-17
00192629031975Lineage26010008260100082026-08-17
00192629031982Lineage26010009260100092026-08-17
00192629032033Lineage26012801260128012026-08-17
00192629032040Lineage26012802260128022026-08-17
00192629032057Lineage26012803260128032026-08-17
00192629163584MICROPORT260136XS260136XS2026-08-17
00192629176515MICROPORT260136SH260136SH2026-08-17
00192629176522MICROPORT260136MD260136MD2026-08-17
00192629176539MICROPORT260136LG260136LG2026-08-17
00192629176546MICROPORT260136XL260136XL2026-08-17
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
00192629031999LineageMicroport Orthopedics Inc.LPH2026-08-18
00192629080515MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629176553MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629031951MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629031968LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031975LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031982LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629163584MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176515MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176522MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176539MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176546MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14