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BoneSource Hydroxyapatite Cement (HAC) Expanded Kit

by Stryker Leibinger

510(k) K991398

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 · Traditional NumberK991398 Date22 Sep 1999ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

The BoneSource Hydroxyapatite Cement (HAC) Expanded Kit is a methyl methacrylate for cranioplasty device. It is used by surgeons for cranial defect repair and craniofacial contour restoration.

The kit consists of hydroxyapatite cement powder, a prefilled syringe of sodium phosphate solution, and a mixing spatula. The cement is mixed intraoperatively and applied to the defect site, where it hardens to provide structural repair or augmentation. This device has received FDA 510(k) clearance.

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Questions

AI-generated answers, 25 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 BoneSource Hydroxyapatite Cement Expanded Kit used for?

    This device is indicated for use by surgeons to perform cranial defect repair and craniofacial contour restoration. It functions as a material that hardens after application to provide structural repair or augmentation at the defect site.

  • What components are included in the kit?

    The kit is supplied with the necessary materials for intraoperative preparation, including hydroxyapatite cement powder, a prefilled syringe containing sodium phosphate solution, and a mixing spatula for combining the components.

  • What is the regulatory status of this device?

    The BoneSource Hydroxyapatite Cement Expanded Kit has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.