Stryker SonicPin System

K170418 · Stryker Trauma GmbH · HTY · Jun 20, 2017 · Orthopedic

Device Facts

• Record ID: K170418
• Device Name: Stryker SonicPin System
• Applicant: Stryker Trauma GmbH
• Product Code: HTY · Orthopedic
• Decision Date: Jun 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

Device Story

Stryker SonicPin System consists of sterile bioresorbable pin and SonicFusion equipment; used for bone fixation in hallux valgus applications. SonicFusion equipment applies ultrasonic energy to liquefy polymeric interface between implant and host bone; material solidifies to create strong fixation. System used in clinical settings by surgeons. Output is physical fixation of bone segments; aids in healing by maintaining alignment. Benefits include stable fixation via bioresorbable material. Modifications in this submission include raw material specification for PLDLLA, color additive concentration, packaging, shelf life, and storage conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including static shear strength, polymer characterization, in vitro degradation, MR safety/compatibility, biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-18), and bacterial endotoxin testing.

Technological Characteristics

Bioresorbable pin composed of PLDLLA polymer. Ultrasonic energy source for insertion via SonicFusion equipment. MR safe. Biocompatibility per ISO 10993 series. Mechanical performance validated via static shear strength testing.

Indications for Use

Indicated for patients requiring maintenance of alignment and fixation of bone fractures, osteotomies, or bone grafts in hallux valgus applications, used in conjunction with appropriate immobilization.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Stryker SonicPin System (K143063)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 20, 2017

Stryker Trauma GmbH Dr. Heike Gustke Staff Regulatory Affairs Specialist. Trauma & Extremities Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 Germany

Re: K170418

Trade/Device Name: Stryker SonicPin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: May 16, 2017 Received: May 24, 2017

Dear Dr. Gustke:

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

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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.

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,

# 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)

K170418

Device Name Stryker SonicPin System

#### Indications for Use (Describe)

The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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| 7 510(k) Summary | |
|-------------------------|----------------------------------------------------|
| Proprietary Name: | Stryker SonicPin System |
| Common Name: | Pin, fixation, smooth |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HTY |
| Device Class: | Class II |
| Sponsor: | Stryker Trauma GmbH |
| | Prof.-Kuentscher-Str. 1-5 |
| | 24232 Schoenkirchen / Germany |
| Contact Person: | Dr. Heike Gustke |
| | Staff Regulatory Affairs Specialist |
| | Prof.-Kuentscher-Str. 1-5 |
| | 24232 Schoenkirchen / Germany |
| | [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | June 6, 2017 |
| Primary Predicate: | Stryker SonicPin System (K143063) |

# Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the modified bioresorbable pin (implant) of Stryker SonicPin System. Modifications include changes of raw material specification for PLDLLA, concentration of color additive, packaging material, shelf life, storage conditions, and labeling documents. Multiple changes occurred by manufacturing.

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The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization.

The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

#### Intended Use

The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

# Indications for Use

The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

#### Summary of Technologies

Device comparison demonstrated that the subject device is substantially equivalent to the previously cleared Stryker SonicPin System (K143063) in regards to intended use, indications for use, design, and operational principles as well as similar in regard to material.

#### Non-Clinical Test

Non-clinical laboratory testing was performed on Stryker SonicPin System under worst case scenario to determine substantial equivalence.

Mechanical testing was performed to evaluate the mechanical performance:

- Static shear strength testing

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Testing demonstrated that Stryker SonicPin System is equivalent in mechanical performance to the predicate device (K143063). Further, the polymer characterization (for the raw material and final, finished device) and the in vitro degradation curve were performed.

Additionally, the magnetic resonance safety and compatibility were evaluated according to FDA Guidance 'Establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment' (2014). The scientifically based rationale demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System can be used in MR environment and is labeled as 'MR safe'.

Biocompatibility testing was performed to evaluate the biological safety of Stryker SonicPin System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. The following testing was performed:

- Chemical characterization according to ISO 10993-18 .
- Cytotoxicity testing according to ISO 10993-5
- Biological and chemical risk assessment .

Testing demonstrated that Stryker SonicPin System is biocompatible.

The Bacterial Endotoxin Testing (BET) was performed and demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System meets the specified endotoxin limit.

# Clinical Testing

Clinical testing was not required for this submission.

### Conclusion

Modifications made to the Stryker SonicPin System have been evaluated in comparison to the predicate device and non-clinical data have been used to support substantial equivalence.

The Stryker SonicPin System is substantially equivalent to the predicate device identified in this premarket notification.