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

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

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
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10

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Primary DI, Brand, Company table
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