STRYKER SONICPIN SYSTEM

K091955 · Howmedica Osteonics Corp. · HTY · Apr 2, 2010 · Orthopedic

Device Facts

• Record ID: K091955
• Device Name: STRYKER SONICPIN SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HTY · Orthopedic
• Decision Date: Apr 2, 2010
• 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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.

Device Story

System comprises bioresorbable PLDLA copolymer implant pins and ultrasonic driver (generator and sonotrode). Ultrasonic energy liquefies pin surface during insertion, allowing adaptation to pre-drilled bone hole geometry; provides mechanical fixation for bone fractures, osteotomies, or grafts. Used in clinical settings by surgeons for hallux valgus correction. Requires concurrent immobilization (e.g., cast, brace, or rigid implants). Benefits include secure bone alignment via bioresorbable fixation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Bioresorbable PLDLA copolymer fixation pins; ultrasonic energy-based insertion mechanism; includes ultrasonic generator and sonotrode driver; intended for bone fixation.

Indications for Use

Indicated for patients requiring bone fracture, osteotomy, or bone graft fixation in hallux valgus applications, requiring concurrent 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

• INION OTPS™ Pin
• Synthes® POLYPIN™ 2.0
• Howmedica Bioabsorbable Pin
• KLS-Martin, L.P. RESORB-X SF®

Submission Summary (Full Text)

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# 1091955 510(k) Summary of Safety and Effectiveness Stryker SonicPin™ System

APR - 2 2010

| Proprietary Name: | Stryker SonicPin™ System |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Smooth Fixation Pin |
| Classification Name/Reference: | Smooth or threaded metallic bone fixation fastener, 21 CFR<br>\$888.3040 |
| Device Product Code: | 87 HTY |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Avital Merl-Margulies<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared. | February 1 2010 |

### Description:

The Stryker SonicPin™ System consists of a bioresorbable implant pin made of a PLDLA copolymer and an ultrasonic unit (generator and sonotrode). Pins are implanted using ultrasonic energy generated by an ultrasonic unit, allowing the pin to adapt to the previously drilled hole. Its intended use is the correction of the Hallux Valgus deformation.

#### Indications:

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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.

#### Substantial Equivalence:

The Stryker SonicPin™ System is substantially equivalent to the INION OTPS™ Pin, Synthes® POLYPIN™ 2.0, Howmedica Bioabsorbable Pin, as well as the KLS-Martin, L.P. RESORB-X SF® in regards to intended use, indications for use, technological characteristics, design, materials, and operational principles as a fracture fixation system.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430

APR - 2 2010

Re: K091955

Trade/Device Name: Stryker SonicPin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: I-ITY Dated: February 1, 2010 Received: February 2, 2010

Dear Ms. Merl-Margulies:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Avital Merl-Margulies

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark M. Milkean

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

## 510(k) Number (if known): 109 j955

Device Name: Stryker SonicPin™ Pin System

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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Mark A. Millum

(Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091953