MODULAR FOOT SYSTEM

K073624 · Orthohelix Surgical Designs, Inc. · HRS · Mar 20, 2008 · Orthopedic

Device Facts

• Record ID: K073624
• Device Name: MODULAR FOOT SYSTEM
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Modular Foot System is indicated for fractures, fusions and osteotomies of the hand, wrist, foot and ankle in pediatric and adult patients.

Device Story

Modular Foot System consists of metallic bone fixation plates and screws; includes 26 plates and 66 screws of various sizes; accompanied by surgical instruments (drill guides, drill bits, drivers). Implants are used by surgeons in clinical settings to stabilize bone fractures, fusions, or osteotomies. Device provides mechanical fixation to support bone healing. No electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including finite element analysis and mechanical testing.

Technological Characteristics

Metallic bone fixation plates and screws; material: Ti-6Al-4V ELI titanium alloy per ASTM F-136. System includes 26 plates and 66 screws. Mechanical fixation principle. No software, electronics, or energy sources.

Indications for Use

Indicated for fractures, fusions, and osteotomies of small bones in the hand, wrist, foot, and ankle in pediatric and adult patients.

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

• Darco Locking Bone Plate System (K061808)
• OrthoHelix MaxLock Small Bone System (K050868)

Submission Summary (Full Text)

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K073624 * 1/2

OrthoHelix Surgical Designs, Inc.

Modular Foot System

510(k) Premarket Notification

MAR 2 0 2008

## 510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

OrthoHelix Surgical Designs, Inc. 1815 W. Market Akron, Ohio 44313 Phone: [phone] Fax: [phone]

Contact Person: Derek Lewis Director of Engineering

Date Prepared: 12/17/07

Name of Device

Modular Foot System

Common or Usual Name

Fixation Plates and Screws

Classification Name

Plate, Fixation, Bone

Predicate Devices

Darco Locking Bone Plate System (K061808) OrthoHelix MaxLock Small Bone System (K050868)

Intended Use

The Modular Foot System is indicated for fractures, fusions and osteotomies of the hand, wrist, foot and ankle in pediatric and adult patients.

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X073604 = 0/0

OrthoHelix Surgical Designs, Inc.

510(k) Premarket Notification

Modular Foot System

Device Description

The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws. The System includes 26 fixation plates and 66 screws, which include all different sizes. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136.

Performance Data

Finite Element Analysis, mechanical testing and hand calculations all confirm that the implants within the Modular Foot System are substantially equivalent to its predicate devices, and that it meets the specified requirements for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and a ribbon flowing from its beak. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthohelix Surgical Designs, Inc. % Mr. Derek Lewis 1815 W. Market Akron, OH 44313

MAR 2 0 2008

K073624 Re: Trade/Device Name: Modular Foot System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 6, 2008 Received: March 6, 2008

Dear Mr. Lewis:

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 such 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); 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. Lewis

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Marti M Millen

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

Enclosure

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## Indications for Use

510(k) Number (if known): TBD

Device Name: Modular Foot System

Indications for Use:

The Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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> Division of General, Restorative, and Neurological Devices

K073624 510(k) Number_