BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

Device Description

The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid. Sodium phosphate sterile solution in a glass syringe with a plastic cap. A polycarbonate mixing spatula, and an instruction for use card packed in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Packages are being provided in sizes ranging from 5g to 50g.

AI/ML Overview

This document is a 510(k) summary for the Bonesource® HAC, a self-setting calcium phosphate cement. It seeks to establish substantial equivalence to previously cleared predicate devices. The information provided does not describe a study involving device performance through testing against acceptance criteria in the context of an AI/algorithm-driven medical device. Instead, it details a regulatory submission for a physical medical device (hydroxyapatite cement).

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document. The 510(k) summary focuses on demonstrating that the Bonesource® HAC is substantially equivalent to predicate devices based on its intended use, technological characteristics, and safety/effectiveness profile, as determined by the FDA's regulatory process for physical medical devices.

Summary

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AUG 0 2 2002

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Bonesource® HAC

General Information

Proprietary Name:	Bonesource® HAC
Common Name:	Hydroxyapatite Cement (HAC)
Proposed Regulatory Class:	Class II
Device Classification:	84GXP 882.5300 Methyl Methacrylate forCranioplasty79FWP 878.3550 Prosthesis, Chin, Interna
Submitter:	Stryker InstrumentsLeibinger Division4100 East Milham AvenueKalamazoo, MI 49001800-253-7370
Submitter's Registration #:	1811755
Manufacturer's Registration #:	9610726
Contact Person:	Wade T. RutkoskieRegulatory Affairs AssociateTelephone: 616-323-4226Fax: 616-323-4215
Summary Preparation Date:	May 3, 2002

510(K) Summary of Safety and Effectiveness BoneSource® HAC May 3, 2002 l

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Predicate Device

BoneSource® HAC is substantially equivalent to BoneSource® Hydrox yapatite Cement Expanded Kit (K991398), BoneSource® Hydroxyapatite Cement (K953339, K964537, and K970400), Biomet Inc.'s Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) and Injectable Mimix™ (K012569).

Device Description

Intended Use

Substantial Equivalence

BoneSource® HAC is substantially equivalent to BoneSource® Hydrox yapatite Cement (HAC) 510 K's K991398, K953339, K964537, and K970400. And that of the predicate devices Biomet Inc.'s Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) and Injectable Mimix™ (K012569). The subject device and equivalent products are all classified as Methyl Methacrylate for Cranioplasty, intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The BoneSource® HAC raises no new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2002

Mr. Wade T. Rutkoskie Regulatory Affairs Representative Stryker Leibinger 4100 East Milham Avenue Kalamazoo, MI 49001

Re: Re: K021440

Trade Name: BoneSource HAC® Regulation Number 882.5300 and 878.3550 Regulatory Name: Methyl Methacrylate for Cranioplasty and Prosthesis, Chin, Internal Regulatory Class: Class II Product Code: GXP and FWP Dated: May 3, 2002 Received: May 6, 2002

Dear Mr. Rutkoskie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration

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Page 2 - Mr. Wade T. Rutkoskie

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark X Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bonesource® HAC

Indication For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use	or	Over-The-Counter Use
(Per 21 CFR 801.109)

for
(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K021440
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Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).