APTUS FOOT 3.5 SYSTEM

K110908 · Medartis AG · HRS · Jun 28, 2011 · Orthopedic

Device Facts

• Record ID: K110908
• Device Name: APTUS FOOT 3.5 SYSTEM
• Applicant: Medartis AG
• Product Code: HRS · Orthopedic
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.

Device Story

The APTUS Foot 3.5 System is a bone fixation system consisting of titanium locking plates and titanium locking/non-locking screws. The device is used by orthopedic surgeons in a clinical setting to stabilize fractures and osteotomies of the calcaneus. The system utilizes plates specifically designed for the left or right calcaneus, secured with 3.5 mm diameter self-tapping screws. The surgeon selects the appropriate plate and screw lengths to provide rigid internal fixation, facilitating bone healing. The device provides mechanical stability to the bone segments, allowing for anatomical alignment and potential patient recovery.

Clinical Evidence

Bench testing only. Performance data included detailed dimensional analysis and mechanical testing of the subject plates and screws compared to predicate devices to demonstrate substantial equivalence.

Technological Characteristics

Materials: Commercially pure titanium Grade 4 (ASTM F67) for plates; titanium alloy (ASTM F136) for screws. Components: Locking plates and 3.5 mm diameter self-tapping locking/non-locking screws. Connectivity: None. Sterilization: Standard methods. Design: Anatomically specific for left/right calcaneus.

Indications for Use

Indicated for patients requiring fixation for fractures and osteotomies of the calcaneus.

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.

Predicate Devices

• Synthes Locking Calcaneal Plates (K991407)
• APTUS Foot System (K091479)

Submission Summary (Full Text)

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APTUS
Foot 3.5 System

K110908 1/2

## 510(k) Summary

JUN 2 8 2011

# Medartis AG

# APTUS® Foot 3.5 System

March 30, 2011

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Medartis AG<br>Hochbergerstrasse 60E<br>CH-4057 Basel, Switzerland<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Ulrike Jehle<br>Regulatory Affairs Manager, Medartis AG |
| Representative/Consultant: | Kevin A. Thomas, PhD<br>Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail] |

### DEVICE NAME AND CLASSIFICATION

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| Trade/Proprietary Name: | APTUS® Foot 3.5 System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------|
| Common Name: | Plate, fixation, bone |
| Classification Regulations: | Single/multiple component metallic bone fixation<br>appliances and accessories<br>21 CFR 888.3030, Class II |
| Product Codes: | HRS |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |

# INTENDED USE

...

The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.

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APTUS® Foot 3.5 System
K110908 2/2

#### DEVICE DESCRIPTION

The APTUS® Foot 3.5 System consists of titanium locking plates and titanium locking and non-locking screws. Plates are provided in three sizes in designs specifically for the right and left calcaneus. The plates are used with TriLock (locking) screws or cortical (non-locking) screws having self-tapping cortical thread forms and a thread diameter of 3.5 mm. The screws are provided in various overall lengths ranging from 16 mm to 60 mm. APTUS Foot 3.5 System plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67. APTUS TriLock and cortical screws are made of titanium alloy conforming to ASTM F136.

#### EQUIVALENCE TO MARKETED DEVICE

APTUS® Foot 3.5 System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Synthes (USA), Synthes Locking Calcaneal Plates, cleared under K991407, and Medartis AG, APTUS® Foot System, cleared under K091479.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics. The subject and predicate devices encompass the same range of physical dimensions, are packaged using the similar materials, and are to be sterilized by the same methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance data was provided to demonstrate substantial equivalence and included detailed dimensional analysis of the subject and predicate designs, and testing of the subject and predicate plates and screws.

Overall, APTUS Foot 3.5 System has the following similarities to the predicate devices:

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

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

Medartis AG % PaxMed International, LLC % Kevin A. Thomas, Ph.D. 11234 El Camino Real, Suite 200 San Diego, CA 92130

JUN 2 8 2011

Re: K110908

Trade/Device Name: APTUS Foot 3.5 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: June 7, 2011 Received: June 8, 2011

Dear Dr. Thomas:

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

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Page 2 - Kevin A. Thomas, Ph.D.

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. 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/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 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.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely yours,

E. Keith

Mar
Dire
Divi

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:

K110908

APTUS® Foot 3.5 System Device Name:

Indications for Use:

The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ・・ rom (Division Sign-Oft) (Division Bignical, Orthopedic, Divisionative Devices 510(k) Number