FDA.reportPublic FDA data

B-P TOTAL HIP SYSTEM

Primary DI
00814193022523
Brand
B-P TOTAL HIP SYSTEM
Company
ENDOTEC, INC.
Model
01-01-0062
Catalog number
01-01-0062
Device description
B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/ULTRACOAT - 62 MM 0 HOLE
Published
2015-09-17
Public version status
Update
Distribution status
Not 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
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
K963101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963101000B-P HEMISPHERICAL ACETABULAR COMPONENTEndotec, Inc.1997-02-12LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193022523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193022523008141930225238141930225230814193022523

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter62Millimeter

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
803488357
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814193020017B-P TOTAL KNEE SYSTEM04-31-200104-31-20012015-09-17
00814193020031B-P TOTAL KNEE SYSTEM04-31-200204-31-20022015-09-17
00814193020062B-P TOTAL KNEE SYSTEM04-31-100404-31-10042015-09-17
00814193020116B-P TOTAL KNEE SYSTEM04-31-200604-31-20062015-09-17
00814193020253B-P TOTAL KNEE SYSTEM04-31-220104-31-22012015-09-17
00814193020505B-P TOTAL KNEE SYSTEM04-31-150204-31-15022015-09-17
00814193020529B-P TOTAL KNEE SYSTEM04-31-150304-31-15032015-09-17
00814193020536B-P TOTAL KNEE SYSTEM04-31-250304-31-25032015-09-17
00814193020543B-P TOTAL KNEE SYSTEM04-31-150404-31-15042015-09-17
00814193020574B-P TOTAL KNEE SYSTEM04-31-250504-31-25052015-09-17
00814193020581B-P TOTAL KNEE SYSTEM04-31-150604-31-15062015-09-17
00814193020628B-P TOTAL KNEE SYSTEM04-32-000304-32-00032015-09-17
00814193020666B-P TOTAL KNEE SYSTEM04-32-001104-32-00112015-09-17
00814193020673B-P TOTAL KNEE SYSTEM04-32-001204-32-00122015-09-17
00814193020710B-P TOTAL KNEE SYSTEM04-32-001604-32-00162015-09-17
00814193020734B-P TOTAL KNEE SYSTEM04-32-002204-32-00222015-09-17
00814193020789B-P TOTAL KNEE SYSTEM04-32-006104-32-00612015-09-17
00814193020802B-P TOTAL KNEE SYSTEM04-32-006304-32-00632015-09-17
00814193020826B-P TOTAL KNEE SYSTEM04-32-006504-32-00652015-09-17
00814193020833B-P TOTAL KNEE SYSTEM04-32-006604-32-00662015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01