FDA.reportPublic FDA data

LUPINE

Primary DI
10886705001033
Brand
LUPINE
Company
DEPUY MITEK, LLC
Model
210704
Catalog number
210704
Published
2025-03-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAMSuture, absorbable, synthetic, polyglycolic acid
HTYPIN, FIXATION, SMOOTH
JDRStaple, fixation, bone
MAIFastener, fixation, biodegradable, soft tissue
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2
HTYPin, Fixation, SmoothOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040827000
K150209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040827000PANALOK LOOP ANCHORDepuy Mitek, A Johnson & Johnson Company2004-04-30MAI
K150209000Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop AncDepuy Mitek, A Johnson and Johnson Company2015-10-06MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705001033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500103310886705001033

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).

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
190572854
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
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705022397INTRAFIX2546532546532015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436711MilleniumAvalign Technologies, Inc.HTY2026-10-20
00888867576032Arthrex®ARTHREX, INC.MBI2026-10-20
00888867576056Arthrex®ARTHREX, INC.MBI2026-10-20
05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
09353903004240FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
09353903004257FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
10884521839830TrexonCovidien LPGAM2026-10-10
10884521839861TrexonCovidien LPGAM2026-10-10
10884521840089TrexonCovidien LPGAM2026-10-10
10884521840126TrexonCovidien LPGAM2026-10-10
10884521840140TrexonCovidien LPGAM2026-10-10
10884521840171TrexonCovidien LPGAM2026-10-10
10884521840195TrexonCovidien LPGAM2026-10-10
10884521840249TrexonCovidien LPGAM2026-10-10
10884521840263TrexonCovidien LPGAM2026-10-10
10884521840270TrexonCovidien LPGAM2026-10-10
10884521840379TrexonCovidien LPGAM2026-10-10
10884521840409TrexonCovidien LPGAM2026-10-10
10884521840430TrexonCovidien LPGAM2026-10-10
10884521840447TrexonCovidien LPGAM2026-10-10
10884521840454TrexonCovidien LPGAM2026-10-10
10884521840461TrexonCovidien LPGAM2026-10-10
10884521840478TrexonCovidien LPGAM2026-10-10
10884521840485TrexonCovidien LPGAM2026-10-10
10884521840492TrexonCovidien LPGAM2026-10-10
10884521840508TrexonCovidien LPGAM2026-10-10
10884521840591TrexonCovidien LPGAM2026-10-10
10884521840614TrexonCovidien LPGAM2026-10-10
10884521840645TrexonCovidien LPGAM2026-10-10
10884521840652TrexonCovidien LPGAM2026-10-10