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FDA 510(k)

Knotless Suture Anchor

K-Number: K231278 · 2023-08-01

ApplicantRiverpoint Medical, LLC
Decision Date2023-08-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Knotless Suture Anchor is a medical device manufactured by Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2023-08-01 under approval number K231278. 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 Knotless Suture Anchor?

Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-08-01. It is manufactured by Riverpoint Medical, LLC. The 510(k) number is K231278.

When was Knotless Suture Anchor approved by the FDA?

Knotless Suture Anchor received FDA 510(k) clearance on 2023-08-01, under approval number K231278.

What company makes Knotless Suture Anchor?

Knotless Suture Anchor is manufactured by Riverpoint Medical, LLC.

What is the FDA product code for Knotless Suture Anchor?

The FDA product code for 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 Riverpoint Medical, LLC

K202242HS Fiber K232411JuggerKnot Soft Anchor OC K231078All-Suture Anchor K220765HS Fiber Cerclage K231128JuggerKnot Soft Anchor K230212OrthoButton AL

View all 11 devices →

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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