Cerasorb" ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spinc, pelvis) that arc not intrinsic to the stability of the bony structure. Following placement in the bony vold or gap, the B-TCP ceramic material is gradually resorbed and replaced with bonc. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.

Device Description

The predicate device Cerasorb™ ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as block forms of different geometry (for example wadge, cylinder, cube, parallelepiped) and in different sizes up to 30cc. The basic pure phase Beta-Tricalcium Phosphate material is also of interconnecting microporosity. Straight through macropores of different size (500-2000um) are mechanically introduced by drilling.

AI/ML Overview

This document is a 510(k) summary for a line extension to Cerasorb™ ORTHO, a bone void filler. It describes a modification to the device, changing its form from granular to additional block shapes. The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a clinical study in the way one might typically describe for a software-as-a-medical-device (SaMD) or diagnostic device.

The provided text focuses on:

Device Identification: Cerasorb™ ORTHO Bone Void Filler.
Predicate Devices: Cerasorb™ ORTHO (granular form), ChronOs, Viitoss Scaffold Synthetic.
Device Modification: Change in size/geometry from granular forms to additional block forms (wadge, cylinder, cube, parallelepiped) up to 30cc, while maintaining the same Beta-Tricalcium Phosphate material with interconnecting porosity and introducing macropores mechanically.
Intended Use: As a bone void filler in the skeletal system for voids/gaps not intrinsic to bony structure stability, to be gradually resorbed and replaced with bone, and mixed with autologous blood (same intended use as the predicate).
Technological Comparison: Stating that all design modifications consist of the same pure phase Beta-Tricalcium Phosphate ceramic material (ASTM F 1088-87), porous, osteoconductive, and resorbable.
FDA Substantial Equivalence Determination: The FDA letter confirms the device is substantially equivalent to the predicate, allowing it to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as this information is not present in the provided document. The 510(k) process for this type of device (a material-based implant with a geometry change) typically relies on demonstrating material equivalence, manufacturing controls, and potentially biocompatibility, rather than a clinical performance study with defined acceptance criteria and statistical endpoints in the manner described by the prompt's questions.

Summary

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AUG 1 3 2003

Special 510 (K) Summary: Line Extension to Cerasorb™ ORTHO (granular form)

Revision August 2003

Submission Information:

Name and Addressof the Sponsor:	curasan AGLindigstrasse 4D - 63801 Kleinostheim, Germany
Contact person:	Dr. Rolf Kaufmann,Regulatory Affairs Manager CerasorbTel.: ++49 - 6027 - 468653Fax: ++49 - 6027 - 468633E - mail: Rolf.Kaufmann@curasan.de
Registered U. S. agent:	Dr. Eric Wiechert109 Shore DriveGarner, NC 27529USAphone: 919 - 7728518, fax: 919 - 7721300E - mail: ewiecher@bellsouth.net

Device Identification:

Cerasorb™ ORTHO
Bone Void Filler Proprietary Name: Common Name: Classification: Unclassified

Predicate Devices:

Cerasorb" ORTHO (granular torm): Bone void filler consisting of pure phase (geta-Tricalcium Phosphate.

ChronOs:

Bone void filler, granules and block forms consisting of Beta-Tricalcium Phosphate

Viitoss Scaffold Synthetic:

Bone void filler, granules and block forms consisting of Beta-Tricalcium Phosphate

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Description of the Device Modification:

The device modification is a change in the size resp. geometry of the bone void filler. The predicate device Cerasorb™ ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as block forms of different geometry (for example wadge, cylinder, cube, parallelepiped) and in different sizes up to 30cc. The basic pure phase Beta-Tricalcium Phosphate material is also of interconnecting microporosity. Straight through macropores of different size (500-2000um) are mechanically introduced by drilling.

Intended Use:

Cerasorb™ ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spine, peivis) that are not intrinsic to the stability of the bony structure. Following placement in the bony vold or gap, the B-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb™ ORTHO should not be in dry form, the material should be mixed with autologous blood.

Statement of technological comparison

All design modifications consist of pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992. The material is porous, osteoconductive and resorbable.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.

Public Health Service

AUG 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Rolf Kaufmann Regulatory Affairs Manager Cerasorb Curasan AG Lindigstrasse 4 63801 Kleinostheim Germany

Re: K031651

Trade Name: Cerasorb ORTHO Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 16, 2003 Received: July 18, 2003

Dear Dr. Wiechert:

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

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Page 2 – Eric Wiechert, Ph.D., RAC

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,

Lila White

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

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Revision August 2003

Item 7. 1 Page 1 of 1

S10(k) Number (if known): Device Name: Cerasorb™ ORTHO

Indications for Use:

Ccrasorb" ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spinc, pelvis) that arc not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the B-TCP ceramic matcrial is gradually resorbed and replaced with bonc. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.

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Concurence of CDRH, Office of Device Evaulation (ODE)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

(Optional Formal 3-10-98)

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.