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MONTAGE XT Cranial Cement

by Orthocon, Inc.

510(k) K253854

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 NumberK253854 Date2 Jan 2026ClearedStatusActive

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  • Withdrawn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
GXP
Device Class
Class II
Regulation
21 CFR Part 882.5300
Advisory Committee
Neurology
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 XT Cranial Cement is a sterile, biocompatible, resorbable material used for cranial defect repair. It consists of two separate putty components containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol, and a mixture of lactide-diester and polyester-based polymers.

The device is supplied as a sterile, single-use product. It has received FDA 510(k) clearance (K253854) and is classified as a Class II medical device under regulation number 882.5300 for use in neurology.

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 MONTAGE XT Cranial Cement used for?

    MONTAGE XT Cranial Cement is used for cranial defect repair. It is a sterile, biocompatible, resorbable material designed to fill and support bone defects in the skull, providing structural integrity during healing.

  • How is MONTAGE XT Cranial Cement supplied and is it sterile?

    MONTAGE XT Cranial Cement is supplied as a sterile, single-use product in two separate putty components. Sterility is maintained until point of use, ensuring it is safe for implantation without additional sterilization.

  • What materials are in MONTAGE XT Cranial Cement and is it resorbable?

    The cement contains granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol, and a mixture of lactide-diester and polyester-based polymers. It is resorbable, meaning it gradually breaks down and is replaced by natural bone over time.

  • What regulatory clearance does MONTAGE XT Cranial Cement have?

    MONTAGE XT Cranial Cement has received FDA 510(k) clearance under submission K253854 and is classified as a Class II medical device under regulation 882.5300 for neurology use, indicating it is substantially equivalent to a legally marketed predicate device.