Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

Device Description

The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.

The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

AI/ML Overview

This 510(k) summary for the Cerasorb® MIX device is for a medical device (bone void filler), not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, standalone performance, ground truth establishment with experts) are not applicable.

The document demonstrates substantial equivalence to predicate devices based on:

Identical Technological Characteristics: The Cerasorb® MIX is a mixture of two previously cleared bone void fillers (Cerasorb® Ortho and Cerasorb® M Ortho) with identical base material (beta-tricalcium phosphate) and similar granule sizes.
Identical Intended Use, Contraindications, Warnings, Precautions, and Adverse Events: The labeling of Cerasorb® MIX is the same as the predicate devices.
Established Safety and Biocompatibility: The safety and biocompatibility of calcium phosphates, the core material, have been established through prior clearances and a long history of clinical use.

Therefore, the "acceptance criteria" for this device are met by demonstrating substantial equivalence to its predicate devices, rather than through a performance study with quantitative metrics for AI/ML outputs.

Here's a breakdown of the requested information, adapted for this device type:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Characteristic	Acceptance Criteria (Demonstrated by Substantial Equivalence via Predicates)	Reported Device Performance (as demonstrated by equivalence to predicates)
Material Composition	Consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP), identical to predicate devices.	Cerasorb® MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP), confirming material identity with predicate Cerasorb® Ortho granules (K014156) and Cerasorb® M Ortho granules (K040216).
Granule Sizes (Mixture)	Mixture of granule sizes used in predicate devices (500-1000 µm from Cerasorb® and 1000-2000 µm from Cerasorb® M).	The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 µm and 1000-2000 µm. The mixing ratio is 1cc to 1cc. This falls within the previously cleared ranges of 50-2000 µm for Cerasorb® Ortho and 50 µm-8000 µm for Cerasorb® M Ortho, demonstrating that the chosen sizes are well-established.
Intended Use	Same as predicate devices: bone void filler for voids or gaps not intrinsic to stability, filling defects caused by surgery, trauma, or degenerative process in skeletal system (extremities, posterolateral spine, pelvis); not for load-bearing applications; gradually resorbed and replaced by new bone.	The stated intended use for Cerasorb® MIX is identical to the predicates, covering use as a bone void filler for non-load-bearing applications in various anatomical sites, with the mechanism of gradual resorption and replacement by new bone.
Biocompatibility	Established biocompatibility for calcium phosphates, as demonstrated by predicate devices.	Biocompatibility is "Established," as it was for both predicate devices. The materials are known and have a long history of safe clinical use, and prior testing for K014156 and K040216 confirmed safety and biocompatibility.
Sterility & Non-pyrogenicity	Sterile and non-pyrogenic, single patient use, as demonstrated by predicate devices.	Device is "Sterile, Non-pyrogenic, Single patient use," which is identical to both predicate devices.
Osteoconductivity	Osteoconductive properties, as demonstrated by predicate devices.	Cerasorb® MIX is "Osteoconductive," aligning with the performance characteristic of both predicate devices.
Mechanical Safety	Does not impart mechanical strength to the surgical site and requires standard stabilization techniques, as demonstrated by predicate devices. This demonstrates that the device itself does not have mechanical load-bearing properties.	Confirmed that the device "Does not impart mechanical strength to surgical site," and explicitly states it is "not indicated for use in load-bearing applications" due to insufficient mechanical strength, requiring standard stabilization techniques. This matches the mechanical safety profile of the predicate devices.
Adverse Events, Warnings, etc.	Labeling contains same intended use, contraindications, warnings, precautions, and adverse events as predicate devices, indicating no new or different safety concerns.	"Labeling contains same intended use, contraindications, warnings, precautions, and adverse events as predicate." This indicates that the safety profile and associated instructions for safe use are consistent with previously cleared devices.
Compliance with FDA Guidance	Meets applicable requirements of FDA guidance documents on bone void fillers as evidenced by the clearances of the predicate devices based on their underlying calcium phosphate salts and their long clinical history.	"Testing performed on the proposed device contained in K014156 and K040216 confirmed that the Cerasorb® MIX device meets the applicable requirements of the FDA guidance documents on bone void fillers." This statement refers to the foundational testing of the components, not new testing for the mixture. Because the mixture leverages components already established to meet these requirements, the mixture also meets them by extension.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices that have already undergone testing and have a history of safe clinical use. There is no new "test set" in the context of an AI/ML performance evaluation for this device. The documentation provided does not detail new clinical studies or a specific test set. The efficacy and safety are inferred from the established performance of the constituent materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment by experts is not relevant for this type of medical device submission. The device's characteristics are determined through material science and preclinical testing referenced from previous clearances, not through expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in studies involving human interpretation or uncertain outcomes (e.g., diagnostic imaging). This is not relevant for a bone void filler's substantial equivalence pathway.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to evaluating diagnostic accuracy or reader performance, typically with AI-assisted tools. This device is a material implant, not a diagnostic or AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the typical AI/ML sense. The "ground truth" for this device's safety and effectiveness is primarily established through:
- Material Science and Characterization: Chemical composition (beta-TCP purity), physical properties (granule size, porosity), and in vitro/in vivo biocompatibility testing of the constituent materials (calcium phosphates) from previous clearances.
- Clinical History/Outcomes Data: The "long history of safe clinical use" mentioned for calcium phosphates represents a form of outcomes data globally, but no specific new outcomes study is presented for the Cerasorb® MIX itself.
- Compliance with Standards: Meeting "applicable requirements of the FDA guidance documents on bone void fillers" based on prior testing of the predicate components.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train AI/ML models. This is a physical device, so no training set is involved.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.

Summary

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510(k) Summary for the Cerasorb® MIX

1. SUBMITTER/510(K) HOLDER

Curasan AG Lindigstrasse 4 63 801 Kleinostheim Germany

··

Dr. Wolf-Dietrich Hübner Contact Person: +49-6027-40900-0 Telephone:

Date Prepared: August 16, 2010

2. DEVICE NAME

Trade Name:	Cerasorb® MIX
Common Name:	Bone Void Filler
Classification Name:	Filler, bone void, calcium compound, 21CFR 888.3045,Product Code MQV

3. PREDICATE DEVICES

Cerasorb® Ortho granules subject of K014156 .
Cerasorb® M Ortho granules subject of K040216 .

4. DEVICE DESCRIPTION

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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads 'K100841'. The characters are written in a simple, slightly irregular style, typical of handwriting. The image is in black and white, with the characters standing out against the background.

5. INTENDED USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Since the Cerasorb® MIX device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216, the technological characteristics are identical to that described in the previously cleared 510(k) premarket notifications. The bone replacement and bone regeneration material Cerasorb® MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000µm and 1000-2000 µm. The mixing ratiò is 1cc to 1cc. Cerasorb® and Cerasorb® M granules.

	Cerasorb® MIX Device	Predicate Cerasorb OrthoGranules	Predicate Cerasorb M OrthoGranules
Regulatory Status	Proposed	K014156	K040216
Target population	For patients with bony voids or gaps resulting from surgery, trauma or degenerativeprocesses and which are not intrinsic to the stability of the bony structure.
Labeling	Labeling contains sameintended use, contraindications,warnings, precautions, andadverse events as predicate.	same	Labeling contains sameintended use, contraindications,warnings, precautions, andadverse events as predicate.
Performance	Osteoconductive	Osteoconductive	Osteoconductive
Sizes	500 - 2000µm	50 - 2000µm	50 µm -8000µm
Porosity	>0 to 500 µm	Micropores >0<80 µm	Interconnecting micro, meso-,and macropores (0 - 500 µm)
Sterility	Sterile, Non-pyrogenicSingle patient use	Sterile, Non-pyrogenicSingle patient use	Sterile, Non-pyrogenicSingle patient use
Bio-compatibility	Established	Established	Established
Mechanical safety	Does not impart mechanicalstrength to surgical site	Does not impart mechanicalstrength to surgical site	Does not impart mechanicalstrength to surgical site

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KJOOS41

7. PERFORMANCE TESTING

The only difference between the proposed device and the predicate devices is that the Cerasorb® MIX device is constructed of two forms of previously cleared calcium phosphate salts. This does not affect safety or effectiveness since they are all resorbable and carry out the same function. The safety and biocompatibility testing performed for calcium phosphates (found in K014156 and K040216) and the long history of safe clinical use. Curasan believes that the proposed device has the identical technological characteristics as the predicate devices; therefore, the Cerasorb® MIX device should behave and function exactly as the parent devices and therefore no new testing is required. Testing performed on the proposed device contained in K014156 and K040216 confirmed that the Cerasorb® MIX device meets the applicable requirements of the FDA guidance documents on bone void fillers. Therefore, the differences in material forms between the proposed and predicate devices do not impact the safety or effectiveness of the device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Curasan AG % Medical Device Consultants, Inc. Cynthia J.M. Nolte, Ph.D. Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

AUG 1 9 2010

Re: K100841

. Trade/Device Name: Cerasorb® MIX Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: July 19, 2010 Received: July 21, 2010

Dear Dr. Nolte:

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 I ( 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/CDRH0ffices/ucm115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Port 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100841

Indications for Use

510(k) Number (if known): K100841

Device Name:

Cerasorb® MIX

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100841

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.