FDA.reportPublic FDA data

Profemur

Primary DI
M684PRGCCME81
Brand
Profemur
Company
Microport Orthopedics Inc.
Model
PRGCCME8
Catalog number
PRGCCME8
Device description
PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 8 EXTENDED
Published
2020-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

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
00192629250154PrimaryGS10
M684PRGCCME81SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629250154001926292501541926292501540192629250154

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.

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
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
false

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
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHKWL2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHKWL2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHKWL2026-10-29
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22