EA Convertible System

Primary DI
00811596031671
Brand
EA Convertible System
Company
CATALYST ORTHOSCIENCE INC.
Model
1231-4602-001
Catalog number
1231-4602-001
Device description
Offset Adapter Trial +0
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
OHXBurr, Corneal, Ac-Powered, Rust Ring Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
OHXBurr, Corneal, Ac-Powered, Rust Ring RemovalOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222317000Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.2022-11-10KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811596031671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596031671008115960316718115960316710811596031671

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder reverse/standard adaptor prosthesis trialA copy of a final shoulder reverse/standard adaptor prosthesis designed to be used before revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is double male taper disc typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079702565
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811596032524F1x Fracture Stem System1232-7551-0011232-7551-0012026-08-25
00811596032531F1x Fracture Stem System1232-7551-0021232-7551-0022026-08-25
00811596032548F1x Fracture Stem System1232-7551-0031232-7551-0032026-08-25
00811596032555F1x Fracture Stem System1232-7552-0011232-7552-0012026-08-25
00811596032562F1x Fracture Stem System1232-7552-0021232-7552-0022026-08-25
00811596032579F1x Fracture Stem System1232-7552-0031232-7552-0032026-08-25
00811596032586F1x Fracture Stem System1232-50031232-50032026-08-25
00811596032593F1x Fracture Stem System1232-4005-0021232-4005-0022026-08-25
00811596032609F1x Fracture Stem System1232-4005-0031232-4005-0032026-08-25
00811596032616F1x Fracture Stem System1232-4005-0041232-4005-0042026-08-25
00811596032623F1x Fracture Stem System1232-4005-0051232-4005-0052026-08-25
00811596032630F1x Fracture Stem System1232-4005-0061232-4005-0062026-08-25
00811596032647F1x Fracture Stem System1232-4005-0071232-4005-0072026-08-25
00811596032654F1x Fracture Stem System1232-4005-0081232-4005-0082026-08-25
00811596032661F1x Fracture Stem System1232-4005-0091232-4005-0092026-08-25
00811596032678F1x Fracture Stem System1232-4005-0101232-4005-0102026-08-25
00811596032685F1x Fracture Stem System1232-4005-0111232-4005-0112026-08-25
00811596032982F1x Fracture Stem System1232-4005-0121232-4005-0122026-08-25
00811596032036Reverse Shoulder System1230-52161230-52162026-08-18
00811596032050Reverse Shoulder System1230-7506-0021230-7506-0022026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEKWS2026-08-03
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
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-13