ILIZAROV DRILL TIP WIRES

K130479 · Smith & Nephew, Inc. · KTT · May 14, 2013 · Orthopedic

Device Facts

• Record ID: K130479
• Device Name: ILIZAROV DRILL TIP WIRES
• Applicant: Smith & Nephew, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: May 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ilizarov Drill Tip Wires are intended to be used for the following indications: Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions. Ilizarov Drill Tip Wires are for single use only.

Device Story

Ilizarov Drill Tip Wires are implantable stainless steel anchorage elements for circular external fixator assemblies. Used by orthopedic surgeons in clinical settings for bone fixation and distraction procedures. Wires are inserted into bone to provide structural support or distraction force. Device facilitates fracture healing, limb lengthening, and deformity correction. Single-use only.

Clinical Evidence

Bench testing only. Mechanical testing compared cutting performance (start/stop cycles until failure), insertion time, and insertion temperature against predicate devices.

Technological Characteristics

Implant-grade stainless steel wires. Available in 1.8mm diameter and 400mm length, with or without stopper. Mechanical fixation component for circular external fixators.

Indications for Use

Indicated for patients requiring bone fixation, limb lengthening, or correction of bony/soft tissue deformities/defects, including post-traumatic joint contracture, fractures, pseudoarthrosis, joint arthrodesis, and infected fractures/nonunions.

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

• Smith & Nephew Smooth and Olive Wires (K994143)
• Ilizarov Drill Tip Wires (K093047)
• Richards Transfixation Wires (K870961)
• Smith & Nephew Drill Tip Kirschner Wires (K-wires) (K090675)
• Ilizarov External Fixation System – Titanium Wires and Washers (K962808)

Submission Summary (Full Text)

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## K130479 510(k) Summary of Safety and Effectiveness

| | Ilizarov Drill Tip Wires | MAY 14 2013 | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|-------------|--|
| Submitted By: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 | | |
| Date: | May 10, 2013 | | |
| Contact Person: | David Henley, Regulatory Affairs Project Manager<br>Tel: [phone] Fax: [phone] | | |
| Proprietary Name: | Ilizarov Drill Tip Wires | | |
| Common Name: | Multilateral Fixators and Accessories | | |
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple component metallic bone fixation appliance and accessories - Class II | | |
| Device Product Code and Panel Code: | KTT / Orthopedics / 87 | | |

### Device Description:

The subject Ilizarov Drill Tip Wires are comprised of implantable anchorage elements designed for use in a multilateral (i.e. a circular) fixator assembly comprised of a structurally purposeful arrangement of simple or complex bridge elements, connection elements and anchorage elements. The subject devices are manufactured from implant grade stainless steel material. Compared to the predicate devices, the subject devices will be available in the following configurations:

| Device Type | Diameter | Length |
|--------------------------------------------------------|----------|--------|
| Ilizarov Drill Tip Wire, 1.8mm x 400mm | 1.8mm | 400mm |
| Ilizarov Drill Tip Wire with Stopper,<br>1.8mm x 400mm | 1.8mm | 400mm |

### Intended Use:

Ilizarov Drill Tip Wires are intended to be used for the following indications:

Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions.

Ilizarov Drill Tip Wires are for single use only.

### Technological Characteristics:

Ilizarov Drill Tip Wires are very similar to legally marketed predicate devices listed below in that they share identical or very similar indications for use, are manufactured from stainless steel material and incorporate identical or very similar technological design characteristics.

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#### Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on identical or very similar design features, overall indications for use, and raw material composition.

- . Smith & Nephew Smooth and Olive Wires - K994143
- Ilizarov Drill Tip Wires K093047 .
- . Richards Transfixation Wires - K870961
- Smith & Nephew Drill Tip Kirschner Wires (K-wires) K090675 .
- . llizarov External Fixation System – Titanium Wires and Washers – K962808

#### Preclinical Testing:

To further support a determination of substantial equivalence, pre-clinical bench testing was conducted on the subject Ilizarov Drill Tip Wires. Mechanical test results were compared against predicate devices. The specific type of pre-clinical testing conducted is described as:

- . Cutting performance of the wire including: number of start/stops prior until failure, time to insertion and insertion temperature
#### Conclusion:

Based on similarities in design and on the results of mechanical testing, the subject device is substantially equivalent to predicates.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a human figure.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: May 14, 2013

Smith and Nephew, Incorporated % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

Re: K130479

Trade/Device Name: Ilizarov Drill Tip Wires Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 15, 2013 Received: March 18, 2013

Dear Mr. Henley:

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 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

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### Page 2 - Mr. David Henley

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark Nigeljierson -S

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Premarket Notification Indications for Use Statement

510(k) Number (if known): K130479

## Device Name: Ilizarov Drill Tip Wires

Indications for Use:

llizarov Drill Tip Wires are intended to be used for the following indications:

- Post-traumatic joint contracture which has resulted in loss of range of motion .
- Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
- . Open and closed fracture fixation
- . Pseudoarthrosis of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction �
- Correction of bony or soft tissue deformities �
- Correction of bony or soft tissue defects
- Joint arthrodesis
- Infected fractures or nonunions

Ilizarov Drill Tip Wires are for single use only.

Prescription Use AND/OR Over-the-Counter Use י (Part 21 CFR 801 Subpart D) י (Part 21 CFR 807 Subpart C)

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

Casey L. Hanley, Ph.D.
Division of Orthopedic:Devices

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