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FDA 510(k)

CEPTRE® Knotted UHMWPE Suture PEEK Anchor

K-Number: K231033 · 2024-01-04

ApplicantHealthium Medtech Limited
Decision Date2024-01-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is a medical device manufactured by Healthium Medtech Limited. It received FDA 510(k) clearance on 2024-01-04 under approval number K231033. 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 CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is a medical device that received FDA 510(k) clearance on 2024-01-04. It is manufactured by Healthium Medtech Limited. The 510(k) number is K231033.

When was CEPTRE® Knotted UHMWPE Suture PEEK Anchor approved by the FDA?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor received FDA 510(k) clearance on 2024-01-04, under approval number K231033.

What company makes CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is manufactured by Healthium Medtech Limited.

What is the FDA product code for CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

The FDA product code for CEPTRE® Knotted UHMWPE Suture PEEK Anchor is MBI.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Healthium Medtech Limited

K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant 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

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

View on FDA Database →

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

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