FDA.reportPublic FDA data

Biocore9 Humeral Resurfacing System

Primary DI
00810068850017
Brand
Biocore9 Humeral Resurfacing System
Company
Biocore9, LLC
Model
Humeral Resurfacing Component 44 mm
Catalog number
02-03-0044
Device description
Biocore9 Humeral Head Resurfacing Shoulder Component 44 mm
Published
2021-09-28
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193122000Biocore9 Humeral Resurfacing SystemBiocore9, LLC2020-05-15HSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068850017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068850017008100688500178100688500170810068850017

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing humeral head prosthesisA sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter44Millimeter

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
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
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
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03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26