FDA.reportPublic FDA data

SecureFix

Primary DI
08903837404855
Brand
SecureFix
Company
HEALTHIUM MEDTECH LIMITED
Model
05.06.0011
Published
2026-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230891000SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited2023-12-28MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08903837404855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903837404855089038374048558903837404855

GMDN Terms#

Term, Definition table
TermDefinition
Meniscus suture anchorA non-bioabsorbable, implantable device designed for suture-based meniscal tear repair and/or meniscus allograft stabilization. It is a small, bar-shaped, synthetic polymer device with holes for passing a suture, which is typically included. It is implanted using dedicated disposable arthroscopic instruments, which may be provided with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
916326705
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08903837747457Polyglactin 91010G75CX18BPR2026-05-25
08903837747518SILK5G75CX18BPR2026-05-25
08903837747532Polypropylene suture8H75CX18BPR2026-05-25
08903837404947Meniscal open cannula05.06.10.01002026-01-14
08903837404954Meniscal knot pusher cutter05.06.10.01012026-01-14
08903837404961Meniscus Diamond Rasp05.06.10.01022026-01-14
08903837404978Meniscus Depth Gauge05.06.10.01032026-01-14
08903837404848SecureFix 05.06.00102026-01-13
08903837404862SecureFix 05.06.00122026-01-13
08903837404879SecureFix 05.06.00132026-01-13
08903837404893SecureFix 05.06.00202026-01-13
08903837404909SecureFix 05.06.00212026-01-13
08903837404916SecureFix 05.06.00222026-01-13
08903837404923SecureFix 05.06.00232026-01-13
08903837404985Meniscal open cannula05.06.10.01102026-01-13
08903837404992Meniscal knot pusher cutter05.06.10.01112026-01-13
08903837562517Securefix UHMWPE suture PEEK Button Meniscus Repair Implant XL - Flexible needle05.06.01242026-01-13
08903837562524Securefix UHMWPE suture PEEK Button Meniscus Repair Implant Flexible needle05.06.01142026-01-13
08903837165978Surgical MeshTVM151-IB2023-08-31
08903837066978Trulene MeshTMM1512024-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993303863AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: WhiteAuxein Medical Private LimitedMBI2026-04-30
08903993457009AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457368AUXILOCK® 2.8mm Titanium Screw-In Suture Anchor With One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457375AUXILOCK® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457467AUXILOCK® GFS Mini, Loop: 15mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-30
08903993457450AUXILOCK® GFS Mini, Loop: 12mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-18
08903993499887AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid:White/BlAuxein Medical Private LimitedMBI2026-04-18
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
07613327661989KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327661996KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662009KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662023KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
08437019739867WasherCap™ Fixation System 11mmABANZA TECNOMED SL.MBI2025-03-10
08437019739898WasherCap Mini Fixation system 3.5mmABANZA TECNOMED SL.MBI2025-02-25
08437019739904WasherCap Mini Fixation system 4.5mmABANZA TECNOMED SL.MBI2025-02-25
08800298539143GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539150GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539167GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539174GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539228GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539235GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
09348215029104Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029111Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029128Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26