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FDA 510(k)

ICONN Revolution Knotless Suture Anchor

K-Number: K182264 · 2018-10-19

ApplicantIconn Orthopedics, LLC
Decision Date2018-10-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICONN Revolution Knotless Suture Anchor is a medical device manufactured by Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2018-10-19 under approval number K182264. 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 ICONN Revolution Knotless Suture Anchor?

ICONN Revolution Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-10-19. It is manufactured by Iconn Orthopedics, LLC. The 510(k) number is K182264.

When was ICONN Revolution Knotless Suture Anchor approved by the FDA?

ICONN Revolution Knotless Suture Anchor received FDA 510(k) clearance on 2018-10-19, under approval number K182264.

What company makes ICONN Revolution Knotless Suture Anchor?

ICONN Revolution Knotless Suture Anchor is manufactured by Iconn Orthopedics, LLC.

What is the FDA product code for ICONN Revolution Knotless Suture Anchor?

The FDA product code for ICONN Revolution Knotless Suture Anchor is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

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 Iconn Orthopedics, LLC

K172491ICONN Square 2.5MM Suture Anchor K180670ICONN Campbell Interference Screw K181680ICONN Answer II 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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