CHARLOTTE (TM) SNAP-OFF SCREW

K133713 · Wrightmedicaltechnologyinc · HWC · Mar 7, 2014 · Orthopedic

Device Facts

• Record ID: K133713
• Device Name: CHARLOTTE (TM) SNAP-OFF SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Mar 7, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Fixation of Small Bone Fragments - Weil osteotomy - Mono-cortical fixation - Osteotomies and fractures fixation in the foot and hand

Device Story

Cortical bone screw for fixation of bone fragments or reconstruction; used in foot and hand surgery. Features self-drilling/self-tapping distal threads; includes a groove in the screw head to allow the drive mechanism shaft to snap off below the screw head surface after insertion. Operated by surgeons in clinical settings. Provides mechanical stabilization of bone; benefits patient by securing fractures or osteotomy sites. Subject device adds new tip geometry for 2.0mm screws and additional lengths for 2.0mm and 2.7mm screws; also includes sterile-provided options.

Clinical Evidence

No clinical data. Bench testing only per ASTM F543-02, including ultimate torque, insertion torque, fully-seated torque, neck break-off torque, removal torque, and axial pull-out.

Technological Characteristics

Material: ASTM F136 (Ti-6Al-4V ELI). Design: Cortical bone screw with self-drilling/self-tapping distal threads and a break-off groove for the drive mechanism. Sterilization: Updated to include sterile-provided products.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction, including small bone fragments, Weil osteotomy, mono-cortical fixation, and osteotomies/fractures in the foot and hand.

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™ Snap-Off Screw (K043583)
• CHARLOTTE™ Snap-Off Screw (K050819)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that appears to be a series of overlapping, angled lines, possibly representing wings or a similar design element. The overall impression is a logo or branding element, likely for a company or product named Wright.

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 www.wmt.com

## 510(K) SUMMARY

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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CHARLOTTE™ Snap-Off Screw.

1. Submitted By:

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

Date:

Contact Person:

March 5, 2014

Leslie Fitch

Senior Regulatory Affairs Specialist [phone]

2. Proprietary Name:

CHARLOTTE™ Snap-Off Screw

Common Name:

Smooth or threaded metallic bone fixation fastener

Classification Name and Reference:

21 CFR 888.3040 - Class II

Device Product Code, Device Panel:

HWC: Orthopedic

3. Predicate Devices:

K043583 - CHARLOTTE™ Snap-Off Screw K050819 - CHARLOTTE™ Snap-Off Screw

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## 4. Device Description

The CHARLOTTE™ Snap-Off screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.

The design features and function of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the design features previously cleared under the CHARLOTTE™ Snap-Off screw and are highlighted below:

- Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
- . Self-drilling and self-tapping features on distal threads
- Groove in head of screw around neck connection to drive mechanism to allow for snap off of ● drive mechanism shaft below screw head surface

The subject screws in this Special 510(k) include a change in the tip geometry of the snap-off 2,0mm diameter screw as well as the introduction of additional screw lengths to the 2.0mm and 2.7mm diameter screws to fill in sizes not previously included. Additionally, screws that are provided sterile have been added.

#### Intended Use ડ.

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- Fixation of Small Bone Fragments ●
- . Weil osteotomy
- Mono-cortical fixation .
- Osteotomies and fractures fixation in the foot and hand .
- 6. Technological Characteristics Comparison

The CHARLOTTE™ Snap-Off Screw and the legally marketed predicate CHARLOTTE™ Snap-Off Screw have identical indications, utilize the same instrumentation, and are identical in material. Sterilization methods have been updated to reflect the addition of products that are provided sterile.

## 7. Substantial Equivalence - Non-Clinical Evidence

Mechanical testing per ASTM F543-02 includes ultimate torque, insertion torque, fully-seated torque, neck break-off torque, removal torque, and axial pull-out. These test demonstrated that the performance of the subject screw is statistically equivalent or greater than the predicate screw.

#### 8. Substantial Equivalence - Clinical Evidence

N/A

## 9. Substantial Equivalence - Conclusions

The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.

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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 stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 7, 2014

Wright Medical Technologies, Inc. Ms. Leslie Fitch Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K133713

Trade/Device Name: CHARLOTTE™ Snap-Off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 29, 2014 Received: February 10, 2014

Dear Ms. Fitch:

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

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## Page 2 - Ms. Leslie Fitch

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.

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/ReportalProblem/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.

Vincen Døevlin -S

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

Enclosure

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#### CHARLOT TE SHERE FRE STRENE CHAWS

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

DIRECEST TO (A) Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

## 510(k) Number (if known)

K133713

## Device Name CHARLOTTE™ Snap-Off Screw

### Indications for Use (Describe)

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone reconstruction. Examples include:

- · Fixation of Small Bone Fragments
- · Weil osteotomy
- · Mono-cortical fixation
- · Osteotomics and fractures fixation in the foot and hand

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY ... " : Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

# Elizabeth @ Frank -S

Division of Orthopedic Devices

FORM FDAig9881e(@ddBJechnology, Inc

CONERCENTRAL

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