CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE

K081374 · Wrightmedicaltechnologyinc · HRS · Sep 9, 2008 · Orthopedic

Device Facts

• Record ID: K081374
• Device Name: CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Sep 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHARLOTTE™ LisFranc Bone Screw is intended to be used for fixation such as: LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus. The CHARLOTTE™ LisFranc Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Device Story

CHARLOTTE™ LisFranc Bone Screw and Plate system; metallic bone fixation hardware. Used by orthopedic surgeons for stabilization of foot bones during arthrodesis or osteotomy procedures. Screws and plates provide mechanical support to bone segments to facilitate healing and repositioning. System includes stainless steel screws (locking and non-locking) and plates. No software or electronic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation system; components manufactured from stainless steel. Includes bone screws (two diameters, various lengths) and fixation plates. Mechanical fixation principle. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring bone fixation in the foot, including LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot/hindfoot arthrodeses or osteotomies, hallux valgus treatment (Scarf/Chevron/Akin osteotomies), and metatarsocuneiform joint arthrodesis for metatarsus primus varus stabilization.

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.

Submission Summary (Full Text)

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K081374 # '12

SEP 0 9 2008

## 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 use of the CHARLOTTE™ LisFranc Bone Screw and CHARLOTTE™ LisFranc Plate.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|------------------------------------------------|
| Date: | May 5, 2008 |
| Contact Person: | Sarah Holtgrewe |
| | Regulatory Affairs Specialist |
| Proprietary Name: | CHARLOTTE™ LisFranc Bone Screw |
| | CHARLOTTE™ LisFranc Plate |
| Common Name: | Bone Screw |
| | Fixation Plate |
| Classification Name and Reference: | 21 CFR 888.3040 Screw, Fixation, Bone—Class II |
| | 21 CFR 888.3030 Plate, Fixation, Bone-Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HRS |
| | Orthopedics/87/HWC |

## DEVICE INFORMATION

#### A. INTENDED USE

The CHARLOTTE™ LisFranc Bone Screw is intended to be used for fixation such as: LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The CHARLOTTE™ LisFranc Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

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K081374 #d

#### B. DEVICE DESCRIPTION

The CHARLOTTE™ LisFranc Bone Screw is offered in 2 diameters and a range of lengths to accommodate variability among patients. All screws are made from stainless steel.

The CHARLOTTE™ LisFranc Plate consists of plates, non-locking screws, and locking screws. All components are manufactured from stainless steel.

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features of the CHARLOTTE™ LisFranc Bone Screw and the CHARLOTTE™ LisFranc Plate are substantially equivalent to the design features of the predicates identified in this 510(k) submission. The safety and effectiveness of the CHARLOTTE™ LisFranc Bone Screw and CHARLOTTE™ LisFranc Plate are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.

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Image /page/2/Picture/1 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 an abstract image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 9 2008

Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K081374

Trade/Device Name: CHARLOTTE™ LisFranc Bone Screw & CHARLOTTE™ LisFranc Plate 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: August 28, 2008 Received: September 3, 2008

Dear Ms. Holtgrewe:

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

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Page 2 - Ms. Sarah Holtgrewe

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.

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 Prestmarket 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,

Mark M. Millman

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): KO8 | 37

Device Name: _CHARLOTTE™ LisFranc Bone Screw & CHARLOTTE™ LisFranc Plate

Indications For Usc:

The CHARLOTTE™ LisFranc Bone Screw is intended to be used for fixation such as: LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The CHARLOTTE™ LisFranc Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Prescription Use XXX (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 De vice Evaluation (ODE) (Division Sign-Off Division of General, Restorative, and Neurological Devices 510(1) Num!

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