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
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15