APTUS FOOT SYSTEM

K091479 · Medartis AG · HRS · Jul 13, 2009 · Orthopedic

Device Facts

• Record ID: K091479
• Device Name: APTUS FOOT SYSTEM
• Applicant: Medartis AG
• Product Code: HRS · Orthopedic
• Decision Date: Jul 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Device Story

The APTUS® Foot System is a metallic bone fixation system consisting of titanium plates, conventional screws, and locking screws. It is used by orthopedic surgeons in a clinical or surgical setting to provide internal fixation for small bone procedures, including fractures, osteotomies, and arthrodesis of the tarsals, metatarsals, and phalanges. The device functions as a mechanical support system to stabilize bone segments during the healing process. It is provided sterile and is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

System consists of titanium fixation plates, conventional screws, and locking screws. Metallic bone fixation appliance. Sterilized using standard processes.

Indications for Use

Indicated for internal fixation of small bones in the foot, specifically for fractures, osteotomies, and arthrodesis of the tarsals, metatarsals, and phalanges.

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)

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

510(k) Summary

## 510(k) Summary

# JUL 1 3 2009

### Medartis AG APTUS® Foot System

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Medartis AG Austrasse 24 CH-4051 Basel, Switzerland Telephone: [phone] Fax: [phone]

Official Contact:

Rosina Cifelli Regulatory Affairs Manager, Medartis AG

Representative/Consultant:

Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] email: [e-mail] [e-mail]

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name : Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

APTUS® Foot System Plate, fixation, bone Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030/21 CFR 888.3040 Class II HRS/HWC Orthopedic Products Panel Orthopedic Devices Branch

#### INTENDED USE

The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

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

### 510(k) Summary

K091479 2/2
APTUS® Foot System

#### DEVICE DESCRIPTION

The APTUS® Foot System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones in the foot.

### EQUIVALENCE TO MARKETED DEVICE

Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® Foot System is substantially equivalent to previously cleared devices. The APTUS® Foot System has the following similarities to the predicate devices:

- has the same intended use, .
- uses the same operating principle, .
- . incorporates the same basic design,
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. .

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1-3 2009

Medartis AG % Ms. Linda K. Schulz PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130

Re: K091479

Trade/Device Name: APTUS Foot System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS, HWC Dated: May 18, 2009 Received: May 19, 2009

Dear Ms. Schulz:

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.

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

### Page 2 - Ms. Linda K. Schulz

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

Sincerely yours.

Obalar Buenno

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

Enclosure

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

APTUS® Foot System

## Indications for Use

510(k) Number (if known): K091479

APTUS® Foot System Device Name:

Indications for Use:

The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

\frac{\text{Oreta}}{\text{(Division Sign-}}

Division of Surgical, Orthopedic, and Resiorative Devices

510(k) Number K091479