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FrameLock; FrameLock Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022370

by Medtronic Xomed, Inc.

Identifiers

510(k) Number
K022370 FDA 510(k)
FDA Product Code
HBG FDA 510(k)
Models / Variants
Framelock FDA 510(k)
Framelock Accessories FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4300 FDA 510(k)
Regulation Number
882.4300 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

FrameLock; FrameLock Accessories is a manual drill and accessory system classified under Drills, Burrs, Trephines & Accessories (Manual) with device class II. It is substantially equivalent to a predicate device and received FDA 510(k) clearance under K022370 with a traditional review pathway. The device is indicated for use in neurology and is manufactured by Medtronic Xomed, Inc.

The FrameLock system mounts using a titanium screw inserted into a pilot hole drilled with stainless steel manual drill and accessories. It is designed for percutaneous installation through a small incision and supports navigation using the sterile drape technique. The device is supplied non-sterile and intended for reusable use after appropriate cleaning and sterilization by the user. Storage and handling should follow manufacturer guidelines for reusable surgical instruments.

Frequently asked questions

What is the FrameLock system used for?

The FrameLock system is indicated for use in neurology and is designed for percutaneous installation through a small incision using a titanium screw mounted via a pilot hole drilled with stainless steel manual drill and accessories, supporting navigation with the sterile drape technique.

Is the FrameLock system supplied sterile or non-sterile?

The FrameLock system is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user, following manufacturer guidelines for reusable surgical instruments.

What materials are used in the FrameLock drill and accessories?

The FrameLock system uses a stainless steel manual drill and accessories to drill a pilot hole, into which a titanium screw is inserted for mounting, as specified in the device description.

How should the FrameLock system be stored and handled?

Storage and handling of the FrameLock system should follow the manufacturer's guidelines for reusable surgical instruments to ensure proper maintenance and readiness for reuse after cleaning and sterilization.

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: FRAMELOCK; FRAMELOCK ACCESSORIES (K022370) — FDA 510 (k) | Innolitics, FRAMELOCK; FRAMELOCK ACCESSORIES 510(k) K022370 - FDA.report, PDF K022370 - Framelock, Framelock; Framelock Accessories - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA 510(k) K022370 24 fields · synced Sep 25, 2026