Stryker Universal Neuro III System AXS Screw

K171152 · Stryker · HBW · May 19, 2017 · Neurology

Device Facts

• Record ID: K171152
• Device Name: Stryker Universal Neuro III System AXS Screw
• Applicant: Stryker
• Product Code: HBW · Neurology
• Decision Date: May 19, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).

Device Story

Stryker Universal Neuro III System AXS screws are bone fasteners used for cranial reconstruction and fixation. This submission introduces two new sterile packaging configurations: sterile procedure packs and sterile screw cartridges. The device is used in clinical settings by surgeons to secure bone plates or cover burr holes following neurosurgical procedures. The screws are implanted to provide rigid fixation of non-loadbearing cranial bone. The device is provided sterile via gamma radiation. The healthcare provider uses the screws to stabilize bone segments, facilitating healing and structural integrity of the cranium. The primary benefit is the provision of pre-sterilized components to streamline surgical workflows and maintain sterility in the operating room.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was supported by non-clinical bench testing, including sterile barrier integrity, transport safety, and process validation for sterilization and cleaning.

Technological Characteristics

The device consists of bone plates and screws for cranial fixation. Materials and manufacturing processes are identical to the predicate. Sterilization is achieved via gamma radiation (SAL 1 x 10^-6). Packaging utilizes sterile barrier systems: flexible bags for procedure packs and sealed blisters for screw cartridges. No software or electronic components are involved.

Indications for Use

Indicated for reconstruction, stabilization, and rigid fixation of non-loadbearing bony areas following craniotomy, craniectomy, and cranial fractures in adults and adolescents aged 12 and older.

Regulatory Classification

Identification

A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.

Predicate Devices

• Stryker Universal Neuro III System AXS Screw (K151387)

Reference Devices

• Stryker QuikFlap Sterile Procedure Pack (K120352)
• Universal Neuro 3 System (K131775)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

May 19, 2017

Stryker Craniomaxillofacial Jonathan Schell Staff Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage. Michigan 49002

Re: K171152

Trade/Device Name: Stryker Universal Neuro III System AXS Screw Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: HBW Dated: April 19, 2017 Received: April 20, 2017

Dear Mr. Schell:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

# Michael J. Hoffmann -S

for

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K171152

Device Name

Stryker Universal Neuro III System AXS Screw

Indications for Use (Describe)

The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is capitalized. A registered trademark symbol is located to the upper right of the word. The word is in black and the background is white.

## Section 5. 510(k) Summary

This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

- SUBMITTER I.

| 510(k) Owner: | Stryker Leibinger GmbH& Co. KG<br>Boetzinger Strasse 41<br>D-79111 Freiburg, Germany |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact<br>Person: | Jonathan Schell<br>Staff Regulatory Affairs Specialist<br>Stryker Craniomaxillofacial<br>750 Trade Centre Way<br>Portage, MI 49002<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | May 12, 2017 |
| II.<br>DEVICE | |
| Trade Name: | Stryker Universal Neuro III System AXS screw |
| Common or Usual<br>name: | Cranioplasty plate fastener |
| Classification<br>name: | Cranioplasty Plate Fastener 21 CFR §882.5360 |
| Regulatory Class: | Class II |
| Product Code: | HBW |

#### PREDICATE DEVICE III.

Predicate: Stryker Universal Neuro III System AXS Screw – K151387 Reference Devices: K120352 Stryker QuikFlap Sterile Procedure Pack, and K131775 Universal Neuro 3 System

{4}------------------------------------------------

#### IV. DEVICE DESCRIPTION

The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are:

- 1. UN III AXS Screws packed in sterile procedure packs, and
- 2. UN III AXS Screws packed in a sterile screw cartridge.

The specific devices included are:

| Description | Packaging Configuration Type |
|-----------------------------------------|------------------------------------|
| 2-Hole Plate Set, SD Screw | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate Set, ST Screw | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate Set, Low Profile with Tab | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate / Burr Hole Cover 14mm Set | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate / Burr Hole Cover 20mm Set | UN III AXS Sterile Procedure Pack |
| Burr Hole Cover 14mm Set | UN III AXS Sterile Procedure Pack |
| UN III AXS Screw, ST, 1.5x4mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, ST, 1.5x5mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, ST, 1.5x6mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x3mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x4mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x5mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, Emergency, 1.7x4mm | UN III AXS Sterile Screw Cartridge |

#### V. INDICATIONS FOR USE

The Stryker Universal Neuro III System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Offering the AXS screw sterile does not alter the Indications for Use statement for the proposed device. The Indications for Use is identical to the predicate device from the Stryker Universal Neuro III System (K151387).

{5}------------------------------------------------

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

The subject device is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria:

- A. Principle of Operation
- B. Technological Characteristics

## A. Principle of Operation

The basic operational principle of the UN III AXS screw is unchanged from the predicate and remains the same.

#### B. Technological Characteristics

The technological characteristics remain the same as the predicate and are unchanged.

#### VII. PERFORMANCE DATA

In Table 5.1 below, the relevant topics, as given in "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff (2016)," are referenced.

#### Table 5-1: Reference of testing

| Category A Sterilization Methods –<br>Established Method | Gamma Radiation |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Sterilization Chamber: | Terminally sterilized in final packaging. |
| SAL | SAL 1 x 10-6 for all products |
| Pyrogenicity | Acceptance Criteria met |
| Packaging Description | Sterile Barrier Systems:<br>Procedure Packs: Flexible bag (sealed)<br>Screws: Blister (sealed) |

#### Process Validations

Overall the subject device is unchanged and has the same implant material and manufacturing process, and the same duration or location of contact to the patient as the predicate device. The only difference between subject device and predicate device lies in the sterile packaging process required with the two sterile barrier systems referenced above.

{6}------------------------------------------------

To evaluate the influence of the changes compared to the predicate device, and based on the Risk Analysis performed on the modification of providing the UN III AXS screw sterile, the following validations were performed and referenced in support of substantial equivalence:

- . Process Cleaning Validation (Bioburden level, Process residuals, Endotoxin Level)
- . Sealing Validation of seals closing the sterile barrier systems
- Process Sterilization Validation Gamma Radiation with VDmax25 Cycle .

A Biocompatibility Assessment was performed to support substantial equivalence respecting the additional manufacturing process steps due to the sterile packaging compared to the predicate device. Substantial equivalence was proven.

## Performance Bench Testing

The following performance bench tests were completed and referenced.

- . Transport safety of product and sterile barrier system including weight and compression test
- Shelf life and integrity of sterile barrier system .
- . Handling test of overall packaging functionality

The subject device met all pre-defined acceptance criteria. Overall, the results of the performance bench tests support the substantial equivalence of the subject device to the predicate device.

## Animal Testing

Animal testing was not required as a basis for substantial equivalence.

## Clinical Testing

Clinical testing was not required as a basis for substantial equivalence.

## VII. CONCLUSIONS

The results of the non-clinical data demonstrate that the modified UN III AXS sterile screws perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.