NANOBONE / GRANULATE

K141189 · Artoss GmbH · MQV · Jan 30, 2015 · Orthopedic

Device Facts

• Record ID: K141189
• Device Name: NANOBONE / GRANULATE
• Applicant: Artoss GmbH
• Product Code: MQV · Orthopedic
• Decision Date: Jan 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are 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 is a resorbable bone void filler composed of nanocrystalline hydroxylapatite (HA) embedded in a porous silica gel matrix. It is supplied as an irregular granulate. The device is intended for surgical use by physicians to fill non-structural bony voids or gaps in the extremities and pelvis. Upon implantation, the material acts as an osteoconductive scaffold that resorbs over time and is replaced by the patient's own bone during the natural healing process. It is used in clinical settings to treat surgically created defects or those resulting from traumatic injury.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (chemical/elemental analysis, phase purity via XRD, dissolution testing, biocompatibility) and an animal study. The animal study used a sheep tibia critical-sized defect model at 6, 12, and 26 weeks, comparing the subject device against autograft (positive control) and empty defects (negative control) to evaluate radiographic, histologic, and histomorphometric characteristics.

Technological Characteristics

Material: Phase-pure non-sintered nanocrystalline hydroxylapatite (HA) in a porous silica gel matrix. Form: Irregular granulate. Structure: Interconnected open porosity mimicking human cancellous bone. Standards: Complies with ASTM F1185 for Calcium Salt Bone Void Fillers. Sterilization: Validated.

Indications for Use

Indicated for patients with surgically created osseous defects or traumatic bone injuries requiring bone void filling in the skeletal system (extremities and pelvis). Not for use in defects intrinsic to bony structure 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

• Actifuse™ Bone Graft Substitute (K040082, K082575)
• NovaBone (K060432, K041613)
• NovaBone AR (K060432, K041613)

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

January 30, 2015

ARTOSS GmbH Dr. Walter Gerike Managing Partner Friedrich-Barnewitz-Str.3 18119 Rostock Germany

Re: K141189

Trade/Device Name: NanoBone® bone graft substitutes - NanoBone® | granulate Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 22, 2014 Received: January 7, 2015

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

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## Page 2 - Dr. Walter Gerike

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K141189

Device Name NanoBone® bone graft substitutes - NanoBone® | granulate

Indications for Use (Describe)

NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone graft substitutes are 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# NanoBone®

## 510(k) Summary

(as required by 21 CFR 807.92)

NanoBone® bone graft substitutes NanoBone® | granulate

510(k) K141189

| 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] |
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| Date Prepared | 28 January 2015 |
|---------------|-----------------|
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| Trade Name | NanoBone® granulate |
|----------------|------------------------------------------|
| Common Name | Bone Void Filler |
| Classification | Resorbable calcium salt bone void filler |
| Name | (21 CFR 888.3045, Product Code MQV) |
| Class | Class II |

| Predicate | Actifuse™ Bone Graft Substitute, K040082, K082575 |
|-----------|---------------------------------------------------|
| Devices | NovaBone, NovaBone AR, K060432, K041613 |

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| Intended Use | NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are 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. |
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| Description | |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NanoBone consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxylapatite (HA) embedded in a highly porous silica gel matrix. The interconnected and open porous structure of NanoBone is similar to human cancellous bone. NanoBone is available as an irregular granulate. |

| Technological<br>Characteristics<br>- Comparison to<br>Predicate<br>Devices | The NanoBone and its predicates have the same intended use, to<br>fill bony voids and gaps that are not intrinsic to the stability of<br>the bony structure. These defects may be surgically created<br>osseous defects or those created from traumatic injury to the<br>bone.<br><br>All forms of the NanoBone material have the same the same<br>indications, contraindications, risks and potential adverse events<br>as the predicate devices. The NanoBone products have the same<br>basic technologies and are composed of equivalent materials. |
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| Performance<br>Data | Bench testing has shown the NanoBone products meet the<br>requirements of all relevant requirements for Calcium Salt Bone<br>Void Fillers, including ASTM F1185. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additional testing was performed to characterize and evaluate<br>the performance of the NanoBone products. This testing<br>included: Chemical / elemental analysis Phase purity / XRD Dissolution testing Animal testing Biocompatibility testing Sterilization validation |

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| Animal testing was performed to demonstrate substantial |
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| equivalence including determination of radiographic, histologic |
| and histomorphometric characteristics of the subject device and |
| the controls in a critical-sized defect model in the sheep tibia. |
| The study time points included 6 weeks, 12 weeks, and 26 |
| weeks. Autograft bone filled defects (positive control) and empty |
| unfilled defects (negative control) also were evaluated at these |
| same time points. |

| Conclusion | |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The NanoBone® granulate has the same intended use and<br>similar technological characteristics as the predicate devices.<br>Performance data demonstrates that the product performs as<br>intended, and is substantially equivalent to its predicates. |