OsteoVation Impact

K162864 · Skeletal Kinetics, LLC · GXP · Jan 13, 2017 · Neurology

Device Facts

• Record ID: K162864
• Device Name: OsteoVation Impact
• Applicant: Skeletal Kinetics, LLC
• Product Code: GXP · Neurology
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoVation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

Device Story

OsteoVation Impact is a self-setting, biocompatible calcium phosphate bone void filler. It consists of two components: a powder (calcium phosphate, carboxymethylcellulose) and a liquid (sodium phosphate, sodium silicate), which are mixed by the user using an included bowl, pestle, and spatula. The resulting paste is moldable and impactable, intended for application by a surgeon to fill cranial defects or augment bone contours. The device is supplied in sterile convenience kits and sterilized via gamma radiation. It is a passive implantable material; it does not involve electronic processing, software, or clinical decision-support algorithms. The device provides a structural scaffold for bone repair.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including working time, setting strength, tensile strength, temperature profile, pH profile, FTIR analysis, and crystallographic analysis (XRD).

Technological Characteristics

Calcium phosphate bone void filler; self-setting paste. Components: calcium phosphate, sodium phosphate (SPMA), carboxymethylcellulose, sodium silicate. Sterilization: Gamma radiation (25-50 kGy; SAL 10^-9). Form factor: 3cc, 5cc, 10cc convenience kits. No energy source, no connectivity, no software.

Indications for Use

Indicated for repair or filling of neurosurgical burr holes, cranial bone defects, and craniotomy cuts (surface area ≤ 25cm2) and restoration/augmentation of cranial bone contours.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• OsteoVation CMF Bone Void Filler (K051784)

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 13, 2017

Skeletal Kinetics, LLC. Alicia Hemphill Director, Regulatory Affairs 10201 Bubb Road Cupertino, California 95014

Re: K162864

Trade/Device Name: OsteoVation Impact Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: October 12, 2016 Received: October 13, 2016

Dear Ms. Hemphill:

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 Part 801); medical device reporting (reporting of medical devicerelated 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 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/ResourcesforYou/Industry/default.htm. 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 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,

## Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162864

Device Name OsteoVation® Impact

Indications for Use (Describe)

Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Michael J. Hoffmanr

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Image /page/3/Picture/0 description: The image shows the logo for Skeletal Kinetics. The logo consists of a blue globe-like icon on the left, followed by the text "Skeletal Kinetics" in a blue sans-serif font. Below the company name, in a smaller, lighter font, is the text "A COLSON ASSOCIATE".

## 510(k) SUMMARY

#### I. SUBMITTER

Skeletal Kinetics 10201 Bubb Road Cupertino, CA 95014 USA

Phone: [phone] Fax: [phone] Email: [e-mail]

Contact Person: Alicia Hemphill Date Prepared: January 12, 2017

Establishment Registration: 3003890476

#### II. DEVICE

Name of the Device: OsteoVation® Impact Common or Usual Name: Hydroxyapatite Cement Classification Name: Methyl Methacrylate For Cranioplasty Regulation: 882.3500 Regulatory Class: Class II Product Code: GXP

#### III. PREDICATE DEVICE

| 510(k) Number | Product<br>Code | Trade Name | Manufacturer |
|---------------|-----------------|------------------|--------------------|
| K051784 | GXP | OsteoVation® CMF | Skeletal Kinetics, |
| Primary | | Bone Void Filler | LLC. |

#### IV. DEVICE DESCRIPTION

OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate.

OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation.

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Image /page/4/Picture/0 description: The image contains the logo for Skeletal Kinetics. The logo features a blue globe-like icon on the left, followed by the text "Skeletal Kinetics" in a blue, sans-serif font. Below the company name, there is a smaller line of text that reads "A COLSON ASSOCIATE".

OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.

#### INDICATIONS FOR USE V.

OsteoVation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

The subject and predicate devices are classified as Methyl Methacrylate for Cranioplasty, and are intended for use in cranialbone applications. In establishing substantial equivalence to the predicate device, Skeletal Kinetics, LLC evaluated the indications for use, materials, technology, and product specifications of those products. Additionally, performance testing has been completed to demonstrate that the Osteo Vation Impact as a bone void filler in cranialbone applications is as safe, and effective, and performs as well as the legally marketed device. The performance testing and device comparison did not raise issues of safety or efficacy.

A formulation change is being made to the powder and liquid working components of the subject device in order optimize the utility of the device during implantation. Sodium phosphate (SPMA) is being added to the liquid component along with a ratio change. A ratio change is also being made to the powder component. This formulation change increases the room temperature range for the utility of the paste from 19℃ - 21℃ to 19℃ - 25℃. Verification testing of the working and setting time shows the formulation change does not affect the performance characteristics of the bone void filler.

The following technological differences exist between the subject and predicate device:

- Increase in room temperature range in Instructions for Use from 19°C -● 21°C to 19°C = 25°C
- Addition of sodium phosphate (SPMA) to liquid component ●
- Ratio change to powder component ●

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Image /page/5/Picture/0 description: The image contains the logo for Skeletal Kinetics. The logo features a blue circular graphic with a network pattern on the left. To the right of the graphic is the text "Skeletal Kinetics" in a blue sans-serif font. Below the text is the phrase "A COLSON ASSOCIATE" in a smaller, lighter font.

#### PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility Testing

No biocompatibility studies were needed to demonstrate safety and efficacy.

## Bench Testing

The following bench testing was conducted:

- Working time and Setting Strength ●
- Tensile Strength ●
- Temperature Profile ●
- pH Profile ●
- FTIR analysis ●
- Crystallographic Analysis

## Test equipment

Osteovation Impact was used as indicated in Instructions for Use, Constant Temperature Water Bath (VWR, S. San Francisco, CA), Phosphate buffered saline (Sigma Chemical Co, St. Louis), Flat Plastic Spatula (Nunc, Rochester, NY), Vortexer (VWR, S. San Francisco, CA) , Mechanical Testing Machine with high load indentor (Instron, Canton, MA), Setting Test containers: Acetal (or other rigid plastic) block molds, pH meter and probe (Corning model 530 meter, model 576156 probe Corning N.Y.), Rigaku Ultima IV XRD, FTIR Spectrometer (Thermo Nicolet, Madison, WI).

| Test | Test Method Summary | Results |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Working time | Tests were performed to determine<br>the workability time of the cement.<br>Measurements included mixing<br>and molding of the paste. | All samples passed the targeted<br>working time and setting<br>strength.<br>The test results demonstrated<br>working time comparable to the<br>predicate device. |
| Setting Time | Testing was conducted to<br>determine the Setting strength<br>(Mean $\ge$ 450N and $\ge$ 700N) at<br>various time points in a target<br>temperature solution, post-<br>sterilization after a target working<br>time. | All samples passed the targeted<br>setting time.<br>The test results demonstrated<br>setting time comparable to the<br>predicate device. |
| Tensile Strength | Testing evaluated the subject | PASS |
| Test | Test Method Summary | Results |
| | device minimum tensile strength at<br>24 hours. | The test results demonstrated<br>tensile strength comparable to |
| | Samples were prepared through<br>the mortal/pestle combination into<br>molds in varying diameters and<br>thickness. Samples were placed in<br>a prepared solution at 37°C for 24<br>hours. Tensile strength testing is<br>conducted using a mechanical<br>testing system. | the predicate device. |
| Temperature<br>Profile | The subject device is mixed and<br>placed into a centrifuge tube and<br>into a 37°C water bath. The<br>temperature profile is recorded at<br>specified intervals using a<br>computer controlled thermocouple<br>for 24 hours. | PASS<br>The test results demonstrated<br>temperature profile comparable<br>to the predicate device. |
| pH Profile | The subject device is placed<br>mixed and placed into a centrifuge<br>tube and into a 37°C water bath.<br>The pH is recorded at specified<br>intervals using a calibrated probe<br>with a TC temperature<br>compensator. | PASS<br>The test results demonstrated<br>pH profile comparable to the<br>predicate device |
| | The test evaluates physiological<br>characteristics of the device. | |
| FTIR Analysis | Mix and incubate subject device<br>for 24 hours. Dry cured sample at<br>37°C for 72 hours. Perform 64<br>scans at typical resolution of 4cm-<br>1.<br>This test determines the formation | PASS<br>FTIR analysis show nearly<br>identical<br>hydroxyapatite<br>structure as the predicate device |
| | of hydroxyapatite. | |
| Crystallographic<br>Analysis | Analyze prepared sample using x-<br>ray diffractometer (XRD). Perform<br>Rietveld analysis determine ratios<br>of each compound in cured<br>cement. | PASS<br>XRD analysis show<br>comparable results as the<br>predicate device. |

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Image /page/6/Picture/0 description: The image contains the logo for Skeletal Kinetics. The logo consists of a blue circular graphic to the left of the company name, "Skeletal Kinetics," which is also in blue. Below the company name, in smaller letters, it says "A COLSON ASSOCIATE."

## Skeletal Kinetics OsteoVation® Impact Submission January 12, 2017

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Image /page/7/Picture/0 description: The image shows the logo for Skeletal Kinetics. The logo consists of a circular graphic to the left of the text "Skeletal Kinetics". Below the text is the phrase "A COLSON ASSOCIATE" in a smaller font size.

## Animal Study

No animal studies were needed to demonstrate safety and efficacy.

## Clinical Studies

No clinical studies were needed to demonstrate safety and efficacy.

#### CONCLUSIONS VIII.

The indication for use, technological characteristics, materials, technology, and product specifications are equivalent. The performance testing conducted, demonstrate that the OsteoVation Impact as a bone void filler in cranialbone applications is as safe, and effective, and performs as well as the legally marketed device and did not raise new issues of safety or efficacy.

Differences in the subject and predicate device formulation change increases the room temperature range for the utility of the paste. Verification testing of the working and setting time shows the formulation change does not affect the performance characteristics of the bone void filler

Additional non-clinical evaluations (tensile strength, temperature profile, pH profile, FTIR analysis, crystallographic analysis) demonstrate comparable results as the test performed for the predicate device.

The conclusions drawn from the nonclinical demonstrate that the device is as safe, and effective, and performs as well as the legally marketed device.