K Number
K032366
Device Name
BONESOURCE HAC FAST SETTING CEMENT
Date Cleared
2003-10-30

(90 days)

Product Code
Regulation Number
882.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.
More Information

Not Found

No
The 510(k) summary describes a calcium phosphate cement for bone repair and augmentation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The device is a physical material kit.

No
The device is a bone cement used for repair and augmentation of cranial and craniofacial bony defects. It acts as a structural material rather than providing a therapeutic effect on a disease or condition.

No
Explanation: The intended use of BoneSource® is for the repair and augmentation of bony contour, which are treatment or restorative functions, not diagnostic ones. It helps to fix or restore anatomical structures rather than identify or characterize a disease or condition.

No

The device description clearly states it is a calcium phosphate cement kit containing powder, solution, and a spatula, which are physical components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that BoneSource® is a material for repairing and augmenting bone defects in the craniofacial skeleton. This is a therapeutic and structural application, not a diagnostic one.
  • Device Description: The description details a bone cement kit with powder, solution, and a spatula. This aligns with a material used for surgical repair, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. BoneSource® is used in vivo (inside the body) for structural repair.

N/A

Intended Use / Indications for Use

BoneSource® HAC Fast Setting Cement 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.

Product codes

GXP

Device Description

The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid, sodium phosphate sterile solution in a syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial, craniofacial skeleton

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K021440, K023718

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

OCT 3 0 2003

K032366
10F2

.

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

Bonesource® HA

General Information

·

-ﻣﺼ

Proprietary Name:Bonesource® HAC
Common Name:Hydroxyapatite Cement (HAC)
Proposed Regulatory Class:Class II
Device Classification:84GXP 882.5300 Methyl Methacrylate for
Cranioplasty
79FWP 878.3550 Prosthesis, Chin, Internal
Submitter:Stryker Instruments
Leibinger Division
4100 East Milham Avenue
Kalamazoo, MI 49001
800-253-7370
Submitter's Registration #:1811755
Manufacturer's Registration #:9610726
Contact Person:Wade T. Rutkoskie
Associate Manager RA/QA
Telephone: 269-323-4226
Fax: 269-323-4215
Summary Preparation Date:July 28, 2003

1

Image /page/1/Picture/0 description: The image shows handwritten text, with the top line reading "K032366." The second line of text reads "2052." The text appears to be written in black ink on a white background.

Equivalent Products

BoneSource® HAC Fast Setting Cement is substantially equivalent to BoneSource® HAC (K021440) and Walter Lorenz QuickSet Mimix™ (K023718). See Appendix 1.

Device Description

The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid, sodium phosphate sterile solution in a syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.

Indications for Use

BoneSource® HAC Fast Setting Cement 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.

Substantial Equivalence

BoneSource® HAC Fast Setting Cement is substantially equivalent to BoneSource® HAC K021440 and Walter Lorenz QuickSet Mimix™ K023718. 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. BoneSource® HAC Fast Setting Cement raises no new issues of safety and effectiveness.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

OCT 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wade T. Rutkoskie Associate Manager RA/QA Stryker Leibinger 4100 E. Milham Avenue Kalamazoo, MI 49024

Re: K032366

Trade Name: BoneSource™ HAC Fast Setting Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 28, 2003 Received: August 1, 2003

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 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

3

Page 2 – Mr. Wade T. Rutkoskie

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Sincerely yours,

Mark A. Milliken

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

Enclosure

4

Page 1 of 1

510(k) Number (if known): K032366

Device Name: Bonesource® HAC Fast Setting Cement

Indication For Use: ﻴﺔ

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.

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

or

Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

for Mark N. Millican
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K032366

Over-The-Counter Use

(Optional Format 1-2-96)