APTUS K-WIRE SYSTEM

K092038 · Medartis AG · HTY · Sep 23, 2009 · Orthopedic

Device Facts

• Record ID: K092038
• Device Name: APTUS K-WIRE SYSTEM
• Applicant: Medartis AG
• Product Code: HTY · Orthopedic
• Decision Date: Sep 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Device Story

APTUS K-Wire System consists of stainless steel wires of varying dimensions; used for bone fracture fixation, bone reconstruction, and as guide pins for secondary implant insertion. Device is a passive orthopedic fastener; operated by surgeons in clinical/OR settings. No active components, software, or algorithms. Provides mechanical stabilization of bone segments or guidance for surgical instrumentation.

Clinical Evidence

No clinical data provided; device is a passive orthopedic fastener.

Technological Characteristics

Stainless steel wires; smooth or threaded metallic bone fixation fasteners. Sterilized using standard processes. No software, electronics, or energy sources.

Indications for Use

Indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants in patients requiring orthopedic surgical intervention.

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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510(k) Summary

K092038*"1/2

# 510(k) Summary

SEP 2 3 2009

# Medartis AG APTUS® K-Wire 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:

Kevin A. Thomas 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® K-Wire System Pin, fixation, smooth Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040 Class II HTY Orthopedic Products Panel Orthopedic Devices Branch

#### INTENDED USE

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

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K092038 #2/2

### DEVICE DESCRIPTION

The APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

# EQUIVALENCE TO MARKETED DEVICE

Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS K-Wire System is substantially equivalent to previously cleared devices. The APTUS K - Wire 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. .

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 3 2009

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

Medartis AG % PaxMed International, LLC Mr. Kevin Thomas 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K092038

Trade/Device Name: APTUS® K-Wire System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: July 2, 2009 Received: July 6, 2009

Dear Mr. 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.

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. Kevin Thomas

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbave Buehm

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): K192038

APTUS® K-Wire System Device Name:

Indications for Use:

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

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)

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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092038