FDA.reportPublic FDA data

Profemur

Primary DI
00192629250161
Brand
Profemur
Company
Microport Orthopedics Inc.
Model
PRGCMS10
Catalog number
PRGCMS10
Device description
PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 10 STANDARD
Published
2020-12-21
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
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201519000PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.2020-12-10JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629250161PrimaryGS10
M684PRGCMS101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629250161001926292501611926292501610192629250161

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with 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
M684141010001ORTHOSET®14101000141010002015-10-24
M684141020001ORTHOSET®14102000141020002015-10-24
M684141030001ORTHOSET®14103000141030002015-10-24
00192629005419ADVANCE®KPONTP26KPONTP262026-09-18
00192629005426ADVANCE®KPONTP29KPONTP292026-09-18
00192629005433ADVANCE®KPONTP32KPONTP322026-09-18
00192629005440ADVANCE®KPONTP35KPONTP352026-09-18
00192629005457ADVANCE®KPONTP38KPONTP382026-09-18
00192629005464ADVANCE®KPONTP41KPONTP412026-09-18
00192629005488ADVANCE®KPON32STKPON32ST2026-09-18
00192629005495ADVANCE®KPON35STKPON35ST2026-09-18
00192629005501ADVANCEKPON38SPKPON38SP2026-09-18
00192629005518ADVANCEKPON41SPKPON41SP2026-09-18
00192629005549ADVANCE®KPRC25HIKPRC25HI2026-09-18
00192629005556ADVANCE®KPRC25LOKPRC25LO2026-09-18
00192629005563ADVANCE®KPRC28HIKPRC28HI2026-09-18
00192629005570ADVANCE®KPRC28LOKPRC28LO2026-09-18
00192629082854EVOLUTIONETPKN1SLETPKN1SL2026-09-18
00192629082861EVOLUTIONETPKN2SLETPKN2SL2026-09-18
00192629082878EVOLUTIONETPKN2PLETPKN2PL2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWY2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWY2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWY2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15