Skip to content

Montage Settable Bone Putty

by Orthocon, Inc.

510(k) K242050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK242050 Date29 Jul 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Montage Settable Bone Putty is a sterile, biocompatible, and resorbable calcium phosphate cement. It is designed to function as a cohesive material for filling bony voids or gaps in the skeletal bones of the extremities, as well as for the repair of neurosurgical burr holes, contiguous craniotomy cuts, and other cranial defects.

This device is supplied as a putty-like material consisting of two separate components. It is intended for use in cranial defects with a surface area no larger than 25cm². The product has received FDA 510(k) clearance.

Other devices from Orthocon, Inc.

See all devices from Orthocon, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of Montage Settable Bone Putty?

    This device is designed to function as a cohesive material for filling bony voids or gaps in the skeletal bones of the extremities. It is also indicated for the repair of neurosurgical burr holes, contiguous craniotomy cuts, and other cranial defects with a surface area no larger than 25cm².

  • How is this bone putty supplied?

    Montage Settable Bone Putty is supplied as a putty-like material consisting of two separate components that are mixed to create the final cement for application.

  • Is this device sterile and resorbable?

    Yes, the product is manufactured as a sterile and biocompatible material. It is also designed to be resorbable, meaning it is intended to be broken down by the body over time after it has been used to fill a bony void or defect.

  • What is the regulatory status of this product?

    Montage Settable Bone Putty has received FDA 510(k) clearance under the K242050 submission. This indicates that the device has been found to be substantially equivalent to a predicate device for its intended use.