FDA.reportPublic FDA data

Argo Knotless GENESYS

Primary DI
20653405988707
Brand
Argo Knotless GENESYS
Company
Conmed Corporation
Model
SPKBC55
Catalog number
SPKBC55
Device description
5.5mm Argo Knotless® GENESYSTM SP Anchor
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAIFastener, fixation, biodegradable, soft tissue
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240090000Argo Knotless GENESYS AnchorConmed Corporation2024-03-05MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405988704PackageGS11In Commercial Distribution
20653405988707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065340598870430653405988704
2065340598870720653405988707

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.217Inch
Outer Diameter5.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405546501Y-KnotlessTM FlexYKF-GYKF-G2026-02-06
20653405990724Y-KnotlessTM FlexYKF-WYKF-W2026-02-06
10845854027851GENESYS PRESSFT, HI-FINB211NB2112015-10-24
10845854027875GENESYS PRESSFT, HI-FINB212NB2122015-10-24
10845854027882GENESYS PRESSFT, HI-FINB261NB2612015-10-24
10845854027905GENESYS PRESSFT, HI-FINB262NB2622015-10-24
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889795154811Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
00889795154828Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
07290019361435OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
07290019361442OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
07290019361459OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
07290019361466OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
00888867576032Arthrex®ARTHREX, INC.MBI2026-10-20
00888867576056Arthrex®ARTHREX, INC.MBI2026-10-20
00888867627840Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627840Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MBI2026-10-07
00817337000586Integrity Retractable Implant InserterAnika Therapeutics, Inc.MBI2026-10-05
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655501Argo KnotlessConmed CorporationMAI2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
20653405546501Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
20653405990724Y-KnotlessTM FlexConmed CorporationMBI2026-02-06