FDA.reportPublic FDA data

Profemur

Primary DI
00192629250352
Brand
Profemur
Company
Microport Orthopedics Inc.
Model
PGHCCLE5
Catalog number
PGHCCLE5
Device description
PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 EXT
Published
2020-10-30
Public version status
New
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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200007000PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.2020-04-25LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629250352PrimaryGS10
M684PGHCCLE51SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629250352001926292503521926292503520192629250352

GMDN Terms#

Term, Definition table
TermDefinition
Revision coated hip femur prosthesisA sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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
00192629298675ProphecyPNV08001PNV080012020-09-25
00192629298682ProphecyPNV08002PNV080022020-09-25
00192629298699ProphecyPNV08003PNV080032020-09-25
00192629298705ProphecyPNV08004PNV080042020-09-25
00192629298712ProphecyPNV08005PNV080052020-09-25
00192629298729ProphecyPNV08006PNV080062020-09-25
00192629298736ProphecyPNV08007PNV080072020-09-25
00192629298743ProphecyPNV08008PNV080082020-09-25
00192629298750ProphecyPNV08009PNV080092020-09-25
00192629298767ProphecyPNV08010PNV080102020-09-25
00192629298774ProphecyPNV08011PNV080112020-09-25
00192629298781ProphecyPNV08012PNV080122020-09-25
00192629298798ProphecyPNV08013PNV080132020-09-25
00192629298804ProphecyPNV08014PNV080142020-09-25
00192629298811ProphecyPNV08015PNV080152020-09-25
00192629298828ProphecyPNV08016PNV080162020-09-25
00192629298835ProphecyPNV08017PNV080172020-09-25
00192629298842ProphecyPNV08018PNV080182020-09-25
00192629298859ProphecyPNV08019PNV080192020-09-25
00192629298866ProphecyPNV08020PNV080202020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030883576Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883583Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883590Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883606Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883613Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883620Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883637Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883644Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883651Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883668Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883675Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883682Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883699Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883705Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883712Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883729Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883736Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883743Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883750Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883767Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883774Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883781Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883798Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883804Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883811Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883828Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883835Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883842Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883859Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883866Mpact 3D Metal FoamMedacta International SALPH2026-09-04