CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER

K070525 · Wrightmedicaltechnologyinc · HWC · Mar 29, 2007 · Orthopedic

Device Facts

• Record ID: K070525
• Device Name: CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Fixation of bone fragments, in long bones or small bones fractures - Fracture management in the foot or hand - Arthrodesis in hand, foot or ankle surgery - Mono or Bi-cortical osteotomies in the foot or hand or in long bones - Treatment of inferior tibio fibular diastasis - Hindfoot arthrodesis

Device Story

The CHARLOTTE™ 7.0 MUC Screw and Washer system is a metallic bone fixation device. It consists of screws of varying lengths and thread patterns, paired with washers designed for straight or oblique placement. Used by orthopedic surgeons in clinical settings, the device provides mechanical stabilization of bone fragments during fracture management, osteotomies, or arthrodesis procedures. By securing bone segments, the device facilitates healing and structural reconstruction. The system is purely mechanical and does not involve electronic or software components.

Clinical Evidence

Bench testing only; testing performed in accordance with ASTM 543-02 to confirm mechanical performance.

Technological Characteristics

Manufactured from Stainless Steel (ASTM F138). Mechanical bone fixation fastener. Dimensions vary by length and thread configuration. No software, electronics, or connectivity.

Indications for Use

Indicated for patients requiring bone fracture fixation or bone reconstruction in long or small bones, including foot, hand, or ankle surgery, osteotomies, and hindfoot arthrodesis.

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.

Predicate Devices

• CHARLOTTE™ High-Demand Compression Screw
• Wright's Pre-amendment Tibia Bolt with Washers

Submission Summary (Full Text)

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K070525

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MAR 2 9 2007

# 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™ 7.0 MUC Screw and Washer.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code and Panel Code:

Wright Medical Technology, Inc.

March 28, 2007

Wesley Reed

Regulatory Affairs Specialist II

CHARLOTTE™ 7.0 MUC Screw and Washer

Screw and Washer

21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II

Orthopedics/87/HWC

#### DEVICE INFORMATION

#### A. INTENDED USE

The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis

### B. DEVICE DESCRIPTION

The CHARLOTTE™ 7.0 MUC Screw and Washer are manufactured from Stainless Steel conforming to ASTM F138. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients and the Washer are offered for straight or oblique screw placement.

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# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ 7.0 MUC Screw and Washer are substantially equivalent to the previously cleared CHARLOTTE™ High-Demand Compression Screw and Wright's Pre-amendment Tibia Bolt with Washers. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ 7.0 MUC Screw and Washer is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. c/o Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

MAR 2 9 2007

Re: K070525

Trade/Device Name: CHARLOTTE™ 7.0 MUC Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 8, 2007 Received: February 28, 2007

Dear Mr. Reed:

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 - Mr. Wesley L. Reed

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Barbara Bucher

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

Enclosure

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070525

# Indications for Use

510(k) Number (if known):

Device Name:_CHARLOTTE™ 7.0 MUC Screw and Washer

Indications For Use:

The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- Fixation of bone fragments, in long bones or small bones fractures
- Fracture management in the foot or hand
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- Treatment of inferior tibio fibular diastasis
- Hindfoot arthrodesis

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)

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K070525

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** Tailgatebend