FDA 510(k)

SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant

K-Number: K230891 · 2023-12-28

Decision Date2023-12-28

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant is a medical device manufactured by Healthium Medtech Limited. It received FDA 510(k) clearance on 2023-12-28 under approval number K230891. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant?

SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant is a medical device that received FDA 510(k) clearance on 2023-12-28. It is manufactured by Healthium Medtech Limited. The 510(k) number is K230891.

When was SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant approved by the FDA?

SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant received FDA 510(k) clearance on 2023-12-28, under approval number K230891.

What company makes SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant?

SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant is manufactured by Healthium Medtech Limited.

What is the FDA product code for SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant?

The FDA product code for SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant is MBI.

Related Clinical Trials

NCT05735119 Embody Post-Market Clinical Follow-Up Study ACTIVE_NOT_RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT02483988 The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant) COMPLETED NCT05463991 Bioengineered Collagen Implant for Urethral Stricture Repair COMPLETED NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED

Related PubMed Literature

PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025)

Other Devices by Healthium Medtech Limited

K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium Button K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button K223889Stativ® Knotted UHMWPE Suture Anchor K231033CEPTRE® Knotted UHMWPE Suture PEEK Anchor

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.