VALOR ANKLE FUSION NAIL SYSTEM

K090857 · Wrightmedicaltechnologyinc · HSB · Jul 14, 2009 · Orthopedic

Device Facts

• Record ID: K090857
• Device Name: VALOR ANKLE FUSION NAIL SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSB · Orthopedic
• Decision Date: Jul 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VALOR™ Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Device Story

VALOR Ankle Fusion Nail System; intramedullary fixation device for tibiotalocalcaneal arthrodesis. System comprises titanium alloy nails and screws; available in multiple diameters and lengths. Used by orthopedic surgeons in clinical/surgical settings to stabilize ankle joint. Device provides mechanical fixation to facilitate bone fusion in patients with severe deformity, arthritis, or post-tumor resection defects. Benefits include structural support for bone healing and stabilization of complex foot/ankle pathologies.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design and material analysis.

Technological Characteristics

Materials: Titanium alloy. Components: Intramedullary nails and screws. Form factor: Multiple diameters and lengths. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis due to severe foot/ankle deformity, arthritis, instability, or skeletal defects post-tumor resection, including Charcot's Foot, talar avascular necrosis, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Submission Summary (Full Text)

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K040857 '/

JUL 1 4 2009

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the VALOR Ankle Fusion Nail System.

| Submitted By: | Wright Medical Technology, Inc. |
|---------------------------------------|----------------------------------------------------|
| Date: | June 9, 2009. |
| Contact Person: | Kellen Hills Regulatory Affairs Specialist |
| Proprietary Name: | VALOR™ Ankle Fusion Nail System |
| Common Name: | Ankle Fusion Nail |
| Regulation Number and Classification: | 21 CFR 888.3020 - Class II |
| Product Code: | HSB: Rod, Fixation, Intramedullary and Accessories |

## DEVICE INFORMATION

#### A. INTENDED USE

The VALOR™ Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after turnor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

#### B. DEVICE DESCRIPTION

The design features of the VALOR™ Ankle Fusion Nail System are described below.

- Nails and screws are manufactured from titanium alloy .
- Nails are available in two diameters and a range of lengths .
- Screws are available in one diameter and a range of lengths .

The design features of the VALOR™ Ankle Fusion Nail System are substantially equivalent to the design features of other devices previously cleared for market.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the VALOR "14 Ankle Fusion Nail System are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the VALOR'M Ankle Fusion Nail System is adequately supported by the substantial equivalence information, materials information and analysis data provided within this Premarket Notification.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Kellen Hills 5677 Airline Road Arlington, TN 38002

Re: K090857

Trade/Device Name: VALOR Ankle Fusion Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 15, 2009 Received: June 18, 2009

#### Dear Mr. Hills:

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.

JUL 1 4 2009

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. product advances if cadvice 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

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Page 2 - Mr. Kellen Hills

(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/cdrh/industry/support/index.html.

Sincerely yours,

Cabare Buelud

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

Page 1 of

Enclosure

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VALORTM Ankle Fusion Nail System INDICATIONS FOR USE Page i of I

# Indications for Use

510(k) Number (if known): 丫伯¶0૪ މ

Device Name:_VALOR™ Ankle Fusion Nail System

Indications For Use:

The VALOR™ Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, distal tibia and Pseudoarthrosis.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souther for hi mym

(Division Sign-Off Division of Surgical, Orthope and Restorative Devices

510(k) Number K090857