← Back to catalogue

ProCinch, QuadCinch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240194

by Riverpoint Medical

Identifiers

510(k) Number
K240194 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 ProCinch, QuadCinch is a smooth or threaded metallic bone fixation fastener, classified under 21 CFR 888.3040. This device is designed for orthopedic applications, providing secure fixation to stabilize bone fragments or implants during surgical procedures.

Supplied as a Class II orthopedic device, the ProCinch, QuadCinch is cleared through the FDA’s Special 510(k) pathway (K240194) under the product code MBI. It is intended for single-use in sterile conditions, adhering to regulatory standards for metallic bone fixation hardware. No additional context on sterility, MRI safety, or reusable status is provided in the available data.

Frequently asked questions

What types of surgical procedures is the ProCinch, QuadCinch designed to assist with, and how does it stabilize bone fragments or implants?

The ProCinch, QuadCinch is designed for orthopedic applications where secure fixation is required to stabilize bone fragments or implants during surgery. It achieves this through its metallic construction, which provides a strong mechanical hold, ensuring stability in procedures like fracture fixation or implant anchoring.

Is the ProCinch, QuadCinch available in different sizes or models, and if so, what variations should I expect?

The available data does not specify exact sizes or model variations of the ProCinch or QuadCinch. However, as a metallic bone fixation fastener, it likely comes in multiple sizes to accommodate different anatomical needs. For precise sizing details, refer to the manufacturer’s product catalog or technical documentation.

How is the ProCinch, QuadCinch supplied, and what should I know about its sterility and single-use status?

The ProCinch, QuadCinch is supplied as a single-use device under sterile conditions, adhering to regulatory standards for metallic orthopedic hardware. This ensures it is ready for immediate use in surgical settings without requiring reprocessing, minimizing infection risks.

What regulatory pathway was followed for FDA clearance of the ProCinch, QuadCinch, and what does this mean for its use in clinical settings?

The ProCinch, QuadCinch was cleared through the FDA’s Special 510(k) pathway (K240194) under product code MBI, classified under 21 CFR 888.3040. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II orthopedic device, allowing its use in clinical settings as intended for secure bone fixation.

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: ProCinch, QuadCinch (K240194) — FDA 510 (k) | Innolitics, K240194 FDA 510(k) - ProCinch | Riverpoint Medical, ProCinch, QuadCinch 510 (k) K240194 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Riverpoint Medical

Sources (1)

  • FDA 510(k) K240194 24 fields · synced Sep 19, 2026