FDA.reportPublic FDA data

AGILON® XO PE-glenoid cemented

Primary DI
04048844546656
Brand
AGILON® XO PE-glenoid cemented
Company
implantcast GmbH
Model
38030128
Published
2022-10-04
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
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222482000AGILON XO Shoulder SystemImplantcast GmbH2022-09-28KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844546656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844546656040488445466564048844546656

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis, prefabricatedAn implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
324369826
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844017309NA258628052026-06-02
04048844708443EPORE® XO022080502026-06-02
04048844711597EPORE® XO022080622026-06-02
04048844711726EPORE® XO02208058002026-06-02
04048844711740EPORE® XO02208062002026-06-02
04048844711795EPORE® XO02208072002026-06-02
04048844711870EPORE® XO022090562026-06-02
04048844711917EPORE® XO02209048002026-06-02
04048844711955EPORE® XO02209056002026-06-02
04048844711979EPORE® XO022090602026-06-02
04048844712020EPORE® XO02209064002026-06-02
04048844712068EPORE® XO02209068002026-06-02
04048844712099EPORE® XO022090722026-06-02
04048844712723NA025632462026-06-02
04048844712747NA025636542026-06-02
04048844712761NA025636622026-06-02
04048844712785NA025640542026-06-02
04048844712808NA025640622026-06-02
04048844712822NA025828422026-06-02
04048844712846NA025836502026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
08033390108065SMR STEMLESSLIMACORPORATE SPAKWT2022-03-17
08033390106757BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106764BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106771BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106788BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106795BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106801BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106818BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106825BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106849BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106856BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106863BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106870BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106887BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106894BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106900BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106917BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106924BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106931BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390038935SMR Shoulder system LIMACORPORATE SPAKWT2018-09-21
08033390085984SMR Shoulder LIMACORPORATE SPAKWT2017-07-05
08033390087834SMR Shoulder LIMACORPORATE SPAKWT2017-07-05
08033390105866SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106412SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106429SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106436SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106443SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390108768SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390108775SMR ShoulderLIMACORPORATE SPAKWT2017-02-25