FDA.reportPublic FDA data

JARVIS Glenoid Rerverse Shoulder Prosthesis

Primary DI
03661489719783
Brand
JARVIS Glenoid Rerverse Shoulder Prosthesis
Company
FOURNITURES HOSPITALIERES INDUSTRIE
Model
271978 - STANDARD GLENOSPHERE D42 LAT 5
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242253000JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie2024-11-25PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661489719783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661489719783036614897197833661489719783

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis headA sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
261839898
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
03661489724442JARVIS GUIDE DE COUPE EXTRA-MODULAIRE272444-JARVIS GUIDE DE COUPE EXTRA-MODULAIRE2026-05-08
03661489724459JARVIS COMPACTEUR INITIAL AMOVIBLE272445-JARVIS COMPACTEUR INITIAL AMOVIBLE2026-05-08
03661489724466JARVIS HUMERAL TRAY N°1272446-JARVIS HUMERAL TRAY N°12026-05-08
03661489724473JARVIS HUMERAL TRAY N°2272447-JARVIS HUMERAL TRAY N°22026-05-08
03661489724480JARVIS HUMERAL INSERT BOX272448-JARVIS HUMERAL INSERT BOX2026-05-08
03661489708275ARROW Reverse Porous Glenoid270827 - ARROW SCREWDRIVER D3.52026-02-18
03661489718175ARROW Short Stem Humeral System271817 - ARROW BROCHE D3 L3502026-02-18
03661489723629JARVIS METAPHYSEAL STEM272362 - JARVIS METAPHYSEAL STEM V2 T12026-01-15
03661489723636JARVIS METAPHYSEAL STEM272363 - JARVIS METAPHYSEAL STEM V2 T22026-01-15
03661489723643JARVIS METAPHYSEAL STEM272364 - JARVIS METAPHYSEAL STEM V2 T32026-01-15
03661489723650JARVIS METAPHYSEAL STEM272365 - JARVIS METAPHYSEAL STEM V2 T42026-01-15
03661489723667JARVIS METAPHYSEAL STEM272366 - JARVIS METAPHYSEAL STEM V2 T52026-01-15
03661489723674JARVIS METAPHYSEAL STEM272367 - JARVIS METAPHYSEAL STEM V2 T62026-01-15
03661489724213JARVIS METAPHYSEAL STEM272421 - JARVIS MODULAR BROACH T12026-01-15
03661489724220JARVIS METAPHYSEAL STEM272422 - JARVIS MODULAR BROACH T22026-01-15
03661489724237JARVIS METAPHYSEAL STEM272423 - JARVIS MODULAR BROACH T32026-01-15
03661489724244JARVIS METAPHYSEAL STEM272424 - JARVIS MODULAR BROACH T42026-01-15
03661489724251JARVIS METAPHYSEAL STEM272425 - JARVIS MODULAR BROACH T52026-01-15
03661489724268JARVIS METAPHYSEAL STEM272426 - JARVIS MODULAR BROACH T62026-01-15
03661489523618JARVIS Diaphyseal Stem Standard272361 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D162025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
05404028001288SurgiCase PlannerMaterialise NVPHX2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncPHX2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26