CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.

CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.

Device Description

CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate hemihydrate and sintered hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for percutaneous injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone.

The ceramic bone substitute material is injected into the bone void in a percutaneous procedure, under visual inspection or under radiographic monitoring, with the use of the accompanying injection device.

AI/ML Overview

The provided text describes a medical device, CERAMENT™ BONE VOID FILLER, and its 510(k) summary for market clearance. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically understood for AI/ML-based medical devices.

The text primarily focuses on:

Device Description: What the device is made of and how it works.
Intended Use: The medical conditions and applications for which the device is designed.
Predicate Device Comparison: It states that the device is "equivalent to the predicate device in intended use, technological characteristics and principles of operation."
Regulatory Clearance: The FDA's decision of substantial equivalence.

The only mention of testing is "Extensive in vitro and in vivo testing has shown CERAMENT™|BONE VOID FILLER to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed CERAMENT™|BONE VOID FILLER to be safe and effective." This is a general statement and does not provide specific acceptance criteria or details of a study with performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. The questions regarding sample size, data provenance, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are also unanswerable based on this text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Bone Support. The logo has the words "BONE SUPPORT" in all caps, with a diamond shape in between the two words. Below the words "BONE SUPPORT" is the phrase "injecting new strength" in a smaller font.

K073316

510(k) Summary

JUN 2 0 2008

Submitter Information

Manufacturer	BONESUPPORT ABScheelevägen 19 AIdeon Science ParkSE-223 70 LUND, SWEDEN
TelephoneCompany fax	+ 46 46 286 53 70+ 46 46 286 53 71
Contact person	Ann-Christine Provoostann-christine.provoost@bonesupport.com+ 46 46 286 53 22 (direct phone)
Date of preparation	10th of June, 2008
	Trade name, Classification name, Class, Regulation
Trade Name	CERAMENT™ BONE VOID FILLER (A0210)
Classification Name	Resorbable calcium salt bone void filler device, MQV
Class	CLASS II (Special Control)
Regulation Number	CFR 888.3045
Predicate devices
510(k) number	Trade name	Manufacturer
K051951	CERAMENT™ BONE VOID FILLER (A 0066)	BONESUPPORT AB
Device description

COMPANY CONFIDENTIAL

the combined mixing injection device, results in a viscous material suitable for percutaneous

BONESUPPORT AB Scheelevägen 19 A SE- 223 70 LUND, Sweden

Tel: +46 46 286 53 70 Fax: +46 46 286 53 71

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Bone Support. The logo has the words "BONE" and "SUPPORT" in a sans-serif font, with a diamond shape in between the two words. Underneath the words is the tagline "injecting new strength" in a smaller font.

injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone.

Intended use

CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or qaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.

CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.

Pre-clinical Testing

Extensive in vitro and in vivo testing has shown CERAMENT™|BONE VOID FILLER to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed CERAMENT™|BONE VOID FILLER to be safe and effective.

Summary

Based on the information provided in this premarket notification, the CERAMENT™ BONE VOID FILLER is equivalent to the predicate device in intended use, technological characteristics and principles of operation.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three streams emanating from its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BONESUPPORT AB % Ms. Ann-Christine Provoost Contact Person Regulatory Affairs Scheclevägen 19A Ideon Science Park SE-223 70 LUND, SWEDEN

JUN 2 0 2008

Re: K073316

Trade/Device Name: Cerament™ Bone Void Filler Regulation Number: CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 17, 2008 Received: April 22, 2008

Dear Ms. Provoost:

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 - Ms. Ann-Christine Provoost

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

K073316 510(k) Number (if known):

CERAMENT™|BONE VOID FILLER (A0210) Device Name:

Indications for Use:

CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilke Dede-Foreman

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K073316

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.