PECTUS STRUT

K082399 · Koros USA, Inc. · HRS · Nov 5, 2009 · Orthopedic

Device Facts

• Record ID: K082399
• Device Name: PECTUS STRUT
• Applicant: Koros USA, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Device is intended for use in surgical procedures to repair Pectus Excavatum and sternal deformities.

Device Story

Adkins-Fonkalsrud Pectus Excavatum Strut is a metallic bone fixation appliance used in surgical procedures to correct Pectus Excavatum and sternal deformities. The device provides structural support to the sternum during the repair process. It is intended for use by surgeons in an operating room setting. The device functions as a mechanical implant to stabilize the chest wall, facilitating proper healing and anatomical correction of the deformity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliance. Class II device. Regulation 21 CFR 888.3030. Product code HRS.

Indications for Use

Indicated for patients requiring surgical repair of Pectus Excavatum and sternal deformities.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Koros USA, Inc. % Mr. Gabriel Koros 610 Flinn Avenue Moorpark, California 93021

NOV - 5 2009

Re: K082399

Trade/Device Name: Adkins-Fonkalsrud Pectus Excavatum Strut Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: October 20, 2009 Received: October 27, 2009

Dear Mr. Koros:

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.

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 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.

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Page 2 - Mr. Gabriel Koros

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrl/comp/ 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/cdrh/mdr/ 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/cdrl/industry/support/index.html.

Sincerely yours,

Mark M. Wilkerson

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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Exhibit C

## INDICATION FOR USE FORM

Page 1 of 1

510 K Number: K082399 Adkins-Fonkalsrud Pectus Excavatum Strut Device Name:

## INDICATION FOR USE:

Device is intended for use in surgical procedures to repair Pectus Excavatum and sternal deformities.

Smite for mxm

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082399

(Do not write below this line.)

Concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription use: (Per 21 CFR 801.109)

or

Over-The-Counter-Use: _ (Optional Format 1- )