FDA.reportPublic FDA data

Biocore9 Acetabular Bearing System

Primary DI
00810068850758
Brand
Biocore9 Acetabular Bearing System
Company
Biocore9, LLC
Model
Acetabular Bearing Component - 48 mm I.D. x 62 mm
Catalog number
01-12-4862
Device description
Acetabular Bearing Component - 48 mm I.D. x 62 mm O.D.
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212761000Biocore9 Acetabular Cup SystemBiocore9, LLC2022-05-17LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068850758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068850758008100688507588100688507580810068850758

GMDN Terms#

Term, Definition table
TermDefinition
Constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
093081548
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
00810068850079Biocore9 Acetabular Cup SystemAcetabular Cup Component - 50 mm - 0 HOLE01-01-00502026-06-26
00810068850086Biocore9 Acetabular Cup SystemAcetabular Cup Component - 52 mm - 0 HOLE01-01-00522026-06-26
00810068850093Biocore9 Acetabular Cup SystemAcetabular Cup Component - 54 mm - 0 HOLE01-01-00542026-06-26
00810068850109Biocore9 Acetabular Cup SystemAcetabular Cup Component - 56 mm - 0 HOLE01-01-00562026-06-26
00810068850116Biocore9 Acetabular Cup SystemAcetabular Cup Component - 58 mm - 0 HOLE01-01-00582026-06-26
00810068850123Biocore9 Acetabular Cup SystemAcetabular Cup Component - 60 mm - 0 HOLE01-01-00602026-06-26
00810068850130Biocore9 Acetabular Cup SystemAcetabular Cup Component - 62 mm - 0 HOLE01-01-00622026-06-26
00810068850147Biocore9 Acetabular Cup SystemAcetabular Cup Component - 64 mm - 0 HOLE01-01-00642026-06-26
00810068850154Biocore9 Acetabular Cup SystemAcetabular Cup Component - 66 mm - 0 HOLE01-01-00662026-06-26
00810068850185Biocore9 Acetabular Cup SystemAcetabular Cup Component - 52 mm - 5 HOLE01-01-05522026-06-26
00810068850192Biocore9 Acetabular Cup SystemAcetabular Cup Component - 54 mm - 5 HOLE01-01-05542026-06-26
00810068850208Biocore9 Acetabular Cup SystemAcetabular Cup Component - 58 mm - 5 HOLE01-01-05582026-06-26
00810068850215Biocore9 Acetabular Cup SystemAcetabular Cup Component - 60 mm - 5 HOLE01-01-05602026-06-26
00810068850222Biocore9 Acetabular Cup SystemAcetabular Cup Component - 62 mm - 5 HOLE01-01-05622026-06-26
00810068850239Biocore9 Acetabular Cup SystemAcetabular Cup Component - 64 mm - 5 HOLE01-01-05642026-06-26
00810068850246Biocore9 Acetabular Cup SystemAcetabular Cup Component - 66 mm - 5 HOLE01-01-05662026-06-26
00810068850284Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 41 mm I.D. x 52 mm 01-12-41522026-06-26
00810068850307Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 44 mm I.D. x 56 mm 01-12-44562026-06-26
00810068850321Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 47 mm I.D. x 60 mm 01-12-47602026-06-26
00810068850338Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 49 mm I.D. x 62 mm 01-12-49622026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862022448NAExactech, Inc.LPH2022-09-19
10885862022448NAExactech, Inc.JDI2022-09-19
10885862022455NAExactech, Inc.JDI2022-09-19
10885862022455NAExactech, Inc.LPH2022-09-19
10885862029867NAExactech, Inc.JDI2022-09-19
10885862029867NAExactech, Inc.LPH2022-09-19
10885862034038NovationExactech, Inc.JDI2022-09-19
10885862034045NovationExactech, Inc.JDI2022-09-19
10885862034052NovationExactech, Inc.JDI2022-09-19
10885862034069NovationExactech, Inc.JDI2022-09-19
10885862034076NovationExactech, Inc.JDI2022-09-19
10885862034083NovationExactech, Inc.JDI2022-09-19
10885862034090NovationExactech, Inc.JDI2022-09-19
10885862034106NovationExactech, Inc.JDI2022-09-19
10885862034113NovationExactech, Inc.JDI2022-09-19
10885862033598NovationExactech, Inc.JDI2022-08-25
10885862033604NovationExactech, Inc.JDI2022-08-25
10885862033611NovationExactech, Inc.JDI2022-08-25
10885862033628NovationExactech, Inc.JDI2022-08-25
10885862033635NovationExactech, Inc.JDI2022-08-25
10885862033642NovationExactech, Inc.JDI2022-08-25
10885862033741NovationExactech, Inc.JDI2022-08-25