FDA.reportPublic FDA data

Biocore9 Femoral Resurfacing Component

Primary DI
00810068850444
Brand
Biocore9 Femoral Resurfacing Component
Company
Biocore9, LLC
Model
Femoral Resurfacing Component - 49 mm
Catalog number
01-03-0049
Device description
Biocore9 Femoral Resurfacing Head Component 49 mm
Published
2021-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXAProsthesis, Hip, Femoral, Resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXAProsthesis, Hip, Femoral, ResurfacingOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201219000Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC2021-01-19KXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068850444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068850444008100688504448100688504440810068850444

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing metallic femoral head prosthesisAn implantable, metallic, partial substitute for a disease-damaged hip joint intended to replace the articulating surface of the femoral head while preserving the natural femoral head and neck. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter49Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093081548
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
00810068850017Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 44 mm02-03-00442021-09-28
00810068850024Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 48 mm02-03-00482021-09-28
00810068850031Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 52 mm02-03-00522021-09-28
00810068850048Biocore9 Humeral Resurfacing SystemHumeral Resurfacing Component 56 mm02-03-00562021-09-28
00810068850383Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 39.5 mm01-03-00392021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 41 mm01-03-00412021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 42.5 mm01-03-00422021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 44 mm01-03-00442021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 45.5 mm01-03-00452021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 47 mm01-03-00472021-09-27
00810068850451Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 51 mm01-03-00512021-09-27
00810068850468Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 52.5 mm01-03-00522021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814193025654SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025661SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025678SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025685SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025692SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025708SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025715SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025722SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025753SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025739SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00814193025746SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00810068850383Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850451Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850468Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
05055196901087Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901094Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901100Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901117Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901124Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901162Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901179Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901186Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901193Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901209Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901216Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17