Syntorr K-wire and Pin System

K161489 · Syntorr, Inc. · HTY · Sep 16, 2016 · Orthopedic

Device Facts

• Record ID: K161489
• Device Name: Syntorr K-wire and Pin System
• Applicant: Syntorr, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Sep 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Syntorr K-wire and Pin System is indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.

Device Story

The Syntorr K-wire and Pin System consists of metallic wires and pins used by orthopedic surgeons in clinical or surgical settings. These devices are inserted into bone to provide temporary or permanent fixation of fractures, facilitate bone reconstruction, serve as guide pins for the placement of other orthopedic implants, or act as traction pins for skeletal traction. The system is purely mechanical; it does not involve software, algorithms, or electronic processing. The device provides structural support to bone segments, aiding in stabilization and healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fasteners (K-wires and pins). Design and materials are consistent with standard orthopedic fixation hardware. No software, electronics, or energy sources involved.

Indications for Use

Indicated for patients requiring open or percutaneous bone fracture fixation, bone reconstruction, guide pins for implant insertion, or skeletal traction.

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.

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

September 16, 2016

Syntorr Inc. % Mr. Samuel Pollard Associate. Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street N.W., 12th Floor Washington, District of Columbia 20005

Re: K161489

Trade/Device Name: Syntorr K-wire And Pin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: August 18, 2016 Received: August 19, 2016

Dear Mr. Pollard:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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/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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161489

Device Name Syntorr K-wire and Pin System

#### Indications for Use (Describe)

The Syntorr K-wire and Pin System is indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.

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

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