NanoBone SBX Putty

K161351 · Artoss GmbH · MQV · Oct 26, 2016 · Orthopedic

Device Facts

• Record ID: K161351
• Device Name: NanoBone SBX Putty
• Applicant: Artoss GmbH
• Product Code: MQV · Orthopedic
• Decision Date: Oct 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

NanoBone® SBX Putty is a bone void filler consisting of nanocrystalline hydroxyapatite granulate embedded in an aqueous gel. It is designed for manual packing into non-load-bearing bony voids or gaps in the extremities and pelvis. The device is intended for use by surgeons in clinical settings to fill defects resulting from surgery or trauma. The material is osteoconductive, resorbing over time and being replaced by natural bone during the healing process. The addition of the aqueous carrier and applicator facilitates delivery compared to the predicate granulate form.

Clinical Evidence

Bench testing included chemical/elemental analysis, XRD phase purity, dissolution, biocompatibility, sterilization, and pyrogenicity. Animal study: 30 New Zealand white rabbits with critical-sized femoral condyle defects compared NanoBone® SBX Putty against NanoBone® granulate and Actifuse® ABX Putty. Histology, histomorphometry, and micro-CT at 4, 8, and 12 weeks demonstrated satisfactory new bone formation and product resorption, confirming performance equivalent to predicates.

Technological Characteristics

Composition: nanocrystalline hydroxyapatite (HA) in a porous silica gel matrix with an aqueous carrier. Structure: interconnected nano, micro, and macro pores mimicking human cancellous bone. Complies with ASTM F1185. Delivered via applicator. Sterilized product.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in the skeletal system (extremities and pelvis) where the defect is not intrinsic to bony stability.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ARTOSS NanoBone® granulate (K141189)
• ApaTech Actifuse ™ ABX E-Z-fil (K071206)

Submission Summary (Full Text)

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

October 26, 2016

ARTOSS GmbH Dr. Walter Gerike Managing Partner Friedrich-Barnewitz-Strasse 3 Rostock 18119 GERMANY

Re: K161351

Trade/Device Name: NanoBone® SBX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 18, 2016 Received: September 20, 2016

Dear Dr. Gerike:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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.

## Indications for Use

510(k) Number (if known) K161351

Device Name NanoBone® SBX Putty

### Indications for Use (Describe)

NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Type of Use (Select one or both, as applicable)

| Exemptions Under Part 286.801 Subpart J | Own Use Consumption (Part 286.801 Subpart A) |
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| | |

|× | Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# NanoBone®

### 510(k) Summary

(as required by 21 CFR 807.92)

### NanoBone® SBX Putty

### 510(k) K161351

| Submitter | ARTOSS GmbH<br>Friedrich-Barnewitz-Staße 3<br>18119 Rostock, Germany<br>Telephone: [phone] - 701<br>Fax: [phone] – 702 |
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| Contact Person | Walter Gerike<br>Managing Partner<br>ARTOSS GmbH<br>[e-mail] |
| Date Prepared | 10/25/2016 |

| Trade Name | NanoBone® SBX Putty |
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| Common Name | Bone Void Filler |
| Classification<br>Regulation | Resorbable calcium salt bone void filler<br>21 CFR 888.3045, Product Code MQV |
| Class | Class II Special Controls |
| Panel code | Orthopedic / 888 |
| Predicate Devices | ARTOSS NanoBone® granulate (K141189)<br>ApaTech Actifuse ™ ABX E-Z-fil (K071206) |
| Intended Use and<br>Indications | NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that<br>are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is<br>indicated for use in the treatment of surgically created osseous defects or osseous<br>defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is<br>intended to be packed into bony voids or gaps of the skeletal system as a bone void<br>filler (i.e., extremities and pelvis). This product provides a bone void filler that<br>resorbs and is replaced by bone during the healing process. |
| Technological<br>Characteristics-<br>Comparison to<br>Predicate Devices | pores. The interconnected and open porous structure of the macro pores of the<br>NanoBone® is similar to human cancellous bone.<br><br>NanoBone® SBX Putty is composed of the same porous calcium phosphate as<br>used in the NanoBone® predicate (K141189), with the same aqueous gel as the<br>predicate Actifuse ABX E-Z-fil (K071206).<br><br>The NanoBone® SBX Putty and the predicate NanoBone granulate (K141189) have<br>the same intended use, to fill bony voids and gaps that are not intrinsic to the<br>stability of the bony structure. These defects may be surgically created osseous<br>defects or those created from traumatic injury to the bone.<br><br>NanoBone® SBX Putty has the same indications, contraindications, risks, basic<br>technology, equivalent materials, and potential adverse events as the NanoBone®<br>granulate predicate (K141189). The only difference between the predicate ARTOSS<br>NanoBone® granulate and the Subject device is the addition of an aqueous carrier<br>and primary packaging in an applicator.<br><br>The Subject devices are therefore substantially equivalent to its predicates. |
| Performance Data | Bench testing has shown the NanoBone® SBX Putty meets the requirements of all<br>relevant requirements for calcium salt bone void filler devices, including ASTM<br>F1185.<br><br>Testing was performed to characterize and evaluate the performance of the<br>NanoBone® products. The testing included:<br>• Chemical / elemental analysis<br>• Phase purity / XRD<br>• Dissolution testing<br>• Biocompatibility assessment / testing<br>• Sterilization validation<br>• Pyrogenicity testing<br>• Animal testing<br><br>Performance testing was undertaken to demonstrate that NanoBone® SBX<br>Putty is capable of healing a critically-sized defect in a clinically relevant<br>implantation site. A well-established critical-sized femoral condyle defect<br>model in the mature New Zealand white rabbit was used. Thirty rabbits<br>were divided into two groups of fifteen. Test articles were implanted<br>bilaterally in 5mm diameter and 10mm deep defects in the lateral aspect of<br>the femoral condyles. Fifteen experimental defects were implanted with<br>NanoBone® SBX Putty. Fifteen control defects were implanted with<br>NanoBone® granulate and another fifteen control defects were implanted<br>with Actifuse® ABX Putty. Five rabbits from each group were sacrificed at 4,<br>8, and 12 weeks after implantation.<br><br>The safety and performance of each test article were evaluated using<br>histology, histomorphometry, micro CT, and image analysis. Outcome<br>measures were new bone formation and product resorption. Based upon<br>the results of this testing, NanoBone SBX Putty performs satisfactorily as a<br>bone void filler and in a manner substantially equivalent to the predicates<br>NanoBone granulate (K141189) and Actifuse ABX Putty (K071206) |

Description NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro

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| Conclusions | NanoBone® SBX Putty has the same intended use and similar technological characteristics as the predicate devices. Performance data demonstrates that the product performs as intended, and is substantially equivalent to its predicates. |
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