CRANIOPLUG

K140309 · Ossdsign AB · GXR · Oct 3, 2014 · Neurology

Device Facts

• Record ID: K140309
• Device Name: CRANIOPLUG
• Applicant: Ossdsign AB
• Product Code: GXR · Neurology
• Decision Date: Oct 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reatial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.

Device Story

OssDsign Cranioplug is a cranial implant designed to cover and plug 14 mm burr holes; consists of a titanium (Ti) mesh plate integrated with a biocompatible calcium phosphate (CaP) ceramic component. Unlike injectable cements requiring intraoperative mixing and in vivo curing, Cranioplug is pre-manufactured, fully cured, and sterile. Used by surgeons in clinical settings to restore cranial integrity following neurosurgical procedures. The device provides mechanical coverage for non-weight bearing skull defects. Clinical benefit includes simplified surgical workflow and stable bone reconstruction.

Clinical Evidence

Bench testing only. Testing included compressive strength (approx. 19 MPa), falling load resistance, 12-hour load deformation, and dissolution testing per ISO 10993-14. Biocompatibility testing included cytotoxicity (ISO 10993-5) and subcutaneous implantation studies in rabbits (ISO 10993-6), which confirmed the device is non-irritant and non-toxic.

Technological Characteristics

Constructed of Grade 3 titanium mesh and a proprietary calcium phosphate ceramic formulation. Dimensions sized for 14 mm burr holes. Titanium thickness is 0.5 mm. Device is pre-cured and supplied sterile. Mechanical properties include compressive strength of ~19 MPa. Testing performed per ISO 10993 standards.

Indications for Use

Indicated for covering and plugging burr holes in the skull and reattaching cranial bone in adults and adolescents age 12 and older; for non-weight bearing applications.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

• Stryker QuikFlap Sterile Procedure Pack (K120352)
• Stryker Injectable Cement (K051603)

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 3, 2014

OssDsign AB % David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, WI 53703

Re: K140309 Trade/Device Name: OssDsign Cranioplug Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: September 4, 2014 Received: September 5, 2014

Dear Mr. Weissburg:

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

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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/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 yours,

Carlos L. Pena - S/A

Carlos L. Peña, PhD, MS 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) K140309

Device Name OssDsign Cranioplug

Indications for Use (Describe)

OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reatial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(k) SUMMARY

## KI40309

- 1. 510(k) Owner Name and Address: OssDsign AB Virdings Allé 2 SE 754 50, Uppsala Sweden Telephone: [phone] Fax: [phone] Email: [e-mail] Contact: Eva Nicklasson
- 2. Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA

- 3. Date prepared: October 3, 2014
- 4. Trade Name: OssDsign® Cranioplug
- 5. Regulation Description: Burr Hole Cover
- 6. Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product Code GXR)
- 7. Class: 2
- 8. Predicates: K I 20352 Stryker QuikFlap Sterile Procedure Pack (Burr Hole Cover, 14 mm) K051603 Stryker Injectable Cement
- 9. Device Description: Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.
- 10. Indications for Use: OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.
- 11. Comparison to predicates: The intended uses of the OssDsign Cranioplug and its predicates are the same. All the devices utilize either titanium mesh or calciumphosphate ceramic. Labeling and materials used are equivalent, except that the calciumphosphate ceramic component of Cranioplug is molded and cured before implantation.

| | OssDsign<br>Cranioplug, (subject<br>device) | Stryker QuikFlap,<br>predicate<br>comparison A,<br>K120352 | Stryker Injectable<br>Cement, predicate<br>comparison B, K051603 |
|--------------------|----------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------|
| Materials | Ti grade 3,<br>proprietary<br>calcium phosphate<br>formulation | Ti grade 2, screws<br>grade 5 | Calcium phosphate<br>cement |
| Titanium thickness | 0.5mm | 0.4mm | N.A. |
| Mix/cure | Mixed and cured in<br>manufacturer's<br>facility | N.A | Mixed in the operating room<br>and cured in vivo |
| Sterility | Sterile | Sterile | Sterile |

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- 12. Testing vs. predicates: Cranioplug and its predicates were tested for bench performance characteristics and material composition. Direct comparison of performance, safety and effectiveness of the Cranioplug and its predicates demonstrate that the Cranioplug is substantially equivalent or superior to its predicates in all characteristics. The table below provides a summary of some of the tests completed.

| Test | Test Method Summary | Results |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compressive<br>strength | Subject device and Stryker Injectable<br>Cement predicate tested with<br>Universal compression testing<br>machine with Imm/min. cross-head<br>speed. | Both devices showed compressive<br>strength of approximately 19 MPa. |
| Falling load | 530 g weight dropped on device and<br>predicate installed in anatomical<br>model. Drop height increased until<br>failure. | Subject device and QuikFlap sustained<br>falling loads below 30 cm. |
| 12 hour load | Device and predicate installed in<br>anatomical model. Device placed on<br>pillow and loaded with 7.5 kg weight<br>on opposite side. Plastic deformation<br>measured after 12 hours. | No deformation of subject device or<br>QuikFlap. |
| Dissolution test | TRIS-buffered solution, pH 7.4 at<br>37C, 120 rpm shaking table per ISO<br>10993-14. | Subject device and Stryker Injectable<br>Cement dissolved less than 25 % after 6<br>weeks. |
| Cytotoxicity | ISO elution method, ISO 10993-5,<br>extracted in IX MEM at 37°C for 24<br>hours | No evidence of causing cell lysis or<br>toxicity. |
| Sensitivity | ISO Subcutaneous Implantation<br>studies – two weeks and six weeks,<br>ISO 10993-6. The test article,<br>sponsor provided control article and<br>the negative control article were<br>subcutaneously implanted in the<br>rabbit. | Classified as a nonirritant as compared<br>to the sponsor provided control article<br>and nonirritant as compared to the<br>negative control article. |