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SureLock W Suture Anchor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151068

by Cayenne Medical, Inc.

Identifiers

510(k) Number
K151068 FDA 510(k)
FDA Product Code
MBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SureLock W Suture Anchor is a sterile, manually operated, single-use device intended for the reattachment of soft tissue to bone in rotator cuff repairs. It is an all-suture anchor with a novel deployment approach that provides mechanical tensioning controlled by the inserter.

The device is supplied as a sterile, single-use product and is not intended for reuse. It is designed to be deployed below the bone cortex using an inserter-controlled mechanism. The SureLock W Suture Anchor has received FDA 510(k) clearance with product code MBI and was reviewed by the Orthopedic advisory committee.

Frequently asked questions

What is the SureLock W Suture Anchor used for?

The SureLock W Suture Anchor is a sterile, single-use device designed for the reattachment of soft tissue to bone specifically in rotator cuff repairs. It features an all-suture anchor with a novel deployment approach that provides mechanical tensioning controlled by the inserter.

How is the SureLock W Suture Anchor supplied?

The device is supplied as a sterile, single-use product and is not intended for reuse. It is designed to be deployed below the bone cortex using an inserter-controlled mechanism.

What regulatory approvals does the SureLock W Suture Anchor have?

The SureLock W Suture Anchor has received FDA 510(k) clearance with product code MBI. It was reviewed by the Orthopedic advisory committee and determined to be substantially equivalent.

Are there different sizes or models of the SureLock W Suture Anchor available?

The device data does not specify different sizes or models. The SureLock W Suture Anchor is presented as a single device configuration for rotator cuff repairs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SureLock W Suture Anchor (K151068) — FDA 510(k) | Innolitics, SureLock® All-Suture Anchor with Inserter-Controlled Deployment, PDF SureLock All-Suture Anchor System - Zimmer Biomet

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cayenne Medical, Inc.

Sources (1)

  • FDA 510(k) K151068 24 fields · synced Sep 28, 2026