Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.

Device Description

Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.

AI/ML Overview

This FDA 510(k) summary describes the Ceracell® Ortho Foam, a resorbable calcium salt bone void filler device, and its substantial equivalence to predicate devices. The study performed focuses on demonstrating the equivalence of the subject device to a primary predicate device using an animal model.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the animal study. Instead, it aims to demonstrate "equivalence" of the subject device's performance to the primary predicate device. The performance is assessed across several parameters.

Acceptance Criteria (Implicit for Equivalence)	Reported Device Performance
Radiographic Characteristics	Equivalent to predicate device K140375
Histologic Characteristics	Equivalent to predicate device K140375
Histomorphometric Characteristics	Equivalent to predicate device K140375

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "animals implanted with autograft (positive control) also were evaluated," implying multiple animals were used, but the exact number of animals in the study (test set) is not specified.
Data Provenance: The study was conducted in a rabbit posterolateral spine fusion model. This indicates preclinical in-vivo data, likely associated with the manufacturer's R&D efforts. The country of origin for the data is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable in this context, as the study is a preclinical animal study evaluating biological and physical characteristics, not human diagnostic interpretation. The "ground truth" here is derived from objective measurements and observations in the animal model.

4. Adjudication Method for the Test Set

This is not applicable as the study did not involve human interpretation or adjudication of diagnostic images or clinical outcomes. The evaluation endpoints included "manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Decalcified paraffin histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E)." These are objective measurements and standardized grading methods.

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

This is not applicable. The device is a bone void filler, not an AI or imaging diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on objective biological and physical measurements and observations from a rabbit posterolateral spine fusion model. This included:

Radiographic evaluations (plain and high-resolution radiography, micro-CT imaging)
Histologic evaluation (undecalcified histologic evaluation, decalcified paraffin histology sections graded according to AAMI/ANSI/ISO 10993-6 Annex E)
Histomorphometric analysis
Manual palpation
Range of motion/flexibility testing

These methods aim to directly assess the biological response and integration of the implant.

8. The Sample Size for the Training Set

This is not applicable. The subject device is a physical product, not a machine learning algorithm, and therefore does not have a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

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September 17, 2018

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curasan AG % Kevin A. Thomas, Ph.D. Vice President, Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K181721

Trade/Device Name: Ceracell® Ortho Foam Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 28, 2018 Received: June 29, 2018

Dear Dr. Thomas:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181721

Device Name

Ceracell® Ortho Foam

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Ceracell® Ortho Foam

curasan AG

June 28, 2018

ADMINISTRATIVE INFORMATION

Manufacturer Name	curasan AGLindigstrasse 4Kleinostheim, 63801 GermanyTelephone +49 6027-40900-0Fax +49 6027-40900-19
Official Contact	Dr. Gregor ThomasMedical Director
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Ceracell® Ortho Foam
Common Name	Filler, bone void, calcium compound
Classification Name	Resorbable calcium salt bone void filler device
Classification Regulations	21 CFR 888.3045, Class II
Product Code	MQV
Classification Panel	Orthopaedic and Rehabilitation Devices Panel
Reviewing Branch	Restorative and Repair Devices Branch (RRDB)

PREDICATE DEVICE INFORMATION

The primary predicate device is K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc. The reference predicate devices are K160566, Cerasorb Ortho Foam, curasan AG, and K103709, Curasan Ceracell® DENTAL, curasan AG.

flarson@paxmed.com

INDICATIONS FOR USE

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SUBJECT DEVICE DESCRIPTION

Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). The porcine collagen scaffold component of the subject device is identical to the collagen component of curasan AG's previously cleared device, Cerasorb Ortho Foam, K 160566. The ceramic component of the subject device (B-tricalcium phosphate with approximately 4% SiO2-MgO-Na2O) is identical to the ceramic component of curasan AG's previously cleared device, Curasan Ceracell® DENTAL, K103709.

Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.

PERFORMANCE DATA

Pre-clinical testing data were submitted according to the guidance documents Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (issued June 2003) and Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 2016). The pre-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, sterilization, material mediated pyrogenicity, bacterial endotoxin, sterile barrier shelf life, and product shelf life.

Animal testing performed to demonstrate substantial equivalence included determination of radiographic. histologic, and histomorphometric characteristics of the subject device and the predicate device in a rabbit posterolateral spine fusion model. Animals implanted with autograft (positive control) also were evaluated. The study time points included baseline (time 0), 6 weeks, and 12 weeks. Evaluation endpoints included manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Decalcified paraffin histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E).

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

curasan AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the legally marketed predicate devices:

K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc .;

K160566, Cerasorb Ortho Foam, curasan AG; and

K103709, Curasan Ceracel1® DENTAL, curasan AG.

A comparison of the technological characteristics of the subject device and the primary predicate device K140375 is provided in the following table.

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	Subject DeviceCeracell® Ortho Foamcurasan AG		Primary Predicate Device
Comparison			K140375MASTERGRAFT® Strip; MASTERGRAFT® PuttyMedtronic Sofamor Danek USA, Inc.
Indications for UseStatement	Ceracell® Ortho Foam is intended to fill bony voids or gapsof the skeletal system (posterolateral spine). These osseousdefects may be surgically created or from traumatic injuryto the bone and are not intrinsic to the stability of the bonystructure. In the posterolateral spine Ceracell® Ortho Foamis to be mixed with autograft bone. The device resorbs andis replaced with bone during the healing process.		MASTERGRAFT® Putty combined with either autogenousbone marrow, and/or sterile water, and/or autograft isindicated as a bone void filler for bony voids or gaps thatare not intrinsic to the stability of the bony structure:Additionally. MASTERGRAFT® Putty can be used withautograft as a bone graft extender. MASTERGRAFT® Puttyis to be gently packed into bony voids or gaps of the skeletalsystem (e.g., the posterolateral spine, pelvis. ilium. and/orextremities). These defects may be surgically createdosseous defects or osseous defects created from traumaticinjury to the bone. MASTERGRAFT® Putty resorbs and isreplaced with bone during the healing process.
Product Code	MQV		MQV
Intended Use	Bone void filler for skeletal system(posterolateral spine)		Bone void filler for skeletal system(extremities, pelvis, and posterolateral spine)
Use in Spine	Yes		Yes
Hydrationprior to use	Sterile saline (required)		Bone marrow aspirate and/or sterile water (required)
Mix with boneprior to use	Autograft bone (required)		Autograft bone (optional)
Design
Form	Granules uniformly dispersed in collagen scaffold85 wt % granules, 15 wt % collagen		Granules uniformly dispersed in collagen scaffold
Granule Size	1000-2000 μm		0.5 mm - 1.6 mm in diameter
Porosity	Granules - up to 75%Final device (granules in collagen scaffold) - 80%		Granules - 80%Final device - not stated in 510(k) Summary
Materials
Calcium salts	β-tricalcium phosphate withapproximately 4% SiO2-MgO-Na2O		β-tricalcium phosphate (85%) andHydroxyapatite (15%)
Scaffold/Binder	Type I and Type III porcine collagen(15 wt % of total material)		Type I bovine collagen
How Provided
Sizes, shapes	Flexible Foam Strip25 x 25 x 4 mm (2.5 cc)25 x 50 x 4 mm (5 cc)25 x 100 x 4 mm (10 cc)65 x 65 x 6 mm (25 cc)	Moldable Foam25 x 12 x 4 mm (1.2 cc)25 x 25 x 4 mm (2.5 cc)25 x 50 x 4 mm (5 cc)25 x 100 x 4 mm (10 cc)65 x 65 x 6 mm (25 cc)	MASTERGRAFT® PuttyVarious volumes:0.75 cc, 1.5 cc, 3.0 cc, 6.0 cc, and 9.0 cc packages
Single use	Provided sterile to end-user		Provided sterile to end-user
Sterile	Gamma irradiation		Not stated
Sterilization	Single patient, single use		Single patient, single use

The primary predicate device is K140375 for substantial equivalence in the animal model performance testing. The reference predicate devices K160566 and K103709 are for substantial equivalence in terms of the subject device material composition.

The subject device and the primary predicate device K140375 have the same intended use, the same product classification and product code (MQV), and have similar Indications for Use statements. The

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subject device and the primary predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the bony structure. The subject device and primary predicate device are indicated for use in the posterolateral spine with autograft bone (extender). Although the subject device and the primary predicate have slightly different Indications for Use language, this difference in language does not change the intended use as a bone void filler in the posterolateral spine.

The subject device and the primary predicate device K140375 each incorporate calcium phosphate materials within a collagen scaffold. The subject device scaffold is Type I and Type III porcine collagen, and the primary predicate K140375 scaffold is Type I bovine collagen. The subject device is made of the identical collagen as the reference predicate device K160566, and the subject device is made of identical calcium phosphate component as the reference predicate device K103709. The subject device and all predicate devices are provided sterile for single-patient, single-use in similar ranges of graft volumes.

The radiographic, histologic, and histomorphometric performance of the subject device were compared to that of the primary predicate device K140375 in a rabbit posterolateral fusion model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the primary predicate device K140375.

CONCLUSION

The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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.