FDA.reportPublic FDA data

B-P TOTAL SHOULDER SYSTEM

Primary DI
00814193025463
Brand
B-P TOTAL SHOULDER SYSTEM
Company
ENDOTEC, INC.
Model
02-04-0612
Catalog number
02-04-0612
Device description
B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 12 MM
Published
2015-09-17
Public version status
Update
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or UncementedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982418000BUECHEL-PAPPAS MODULAR SALVAGE STEMEndotec, Inc.1999-04-29MJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193025463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193025463008141930254638141930254630814193025463

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head bipolar componentA sterile, implantable, hemisphere-shaped component of a bipolar partial shoulder prosthesis designed to interface with the glenoid fossa on its outer surface where it freely rotates, and interface with a humeral head prosthesis on its inner surface where it allows free rotation of the head. It is typically composed of an outer metal shell and an inner polyethylene (PE) liner.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

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
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18