FDA.reportPublic FDA data

SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right

Primary DI
08903837093844
Brand
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right
Company
HEALTHIUM MEDTECH LIMITED
Model
S29-1802-TQ
Published
2024-07-30
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
08903837093844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903837093844089038370938448903837093844

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
08903837224453MonoglydeE11F90CY192026-08-19
08903837224491MonoglydeE11H90CY162026-08-19
08903837224514TruleneEP56133-452026-08-19
08903837224538TruleneEP66113-452026-08-19
08903837224552TruleneEP66133-452026-08-19
08903837337214MonoglydeE11F90CX19P2026-08-19
08903837337238TruleneE8H45CX13P2026-08-19
08903837337252PDSYNTHE9F75CX19P2026-08-19
08903837402325TrulonE15G75CX13P2026-08-19
08903837402349TruglydeE18F75CX19P2026-08-19
08903837402363TRUSILKE5E75CX26P2026-08-19
08903837402387TRUSILKE5H60CX16P2026-08-19
08903837799265MonoglydeE11G90CY19P2026-08-19
08903837799289MonoglydeE11G90CY16P2026-08-19
08903837799302MonoglydeE14H45CX16P2026-08-19
08903837799326TrulonE15I45CX13P2026-08-19
08903837252722Meniscal open cannulaSingle Lumen2026-08-18
08903837252746Meniscal open cannulaUp/Down2026-08-18
08903837252753Meniscal open cannulaLeft/Right2026-08-18
08903837252760Meniscal open cannulaUp Bend2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCMBI2026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCMBI2026-08-25
00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
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