FDA.reportPublic FDA data

Securefix UHMWPE suture PEEK Button Meniscus Repair Implant Flexible needle

Primary DI
08903837562524
Brand
Securefix UHMWPE suture PEEK Button Meniscus Repair Implant Flexible needle
Company
HEALTHIUM MEDTECH LIMITED
Model
05.06.0114
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
08903837562524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903837562524089038375625248903837562524

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
08903837404855SecureFix 05.06.00112026-01-13
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
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