METASURG DIGIFUSE IMPLANT

K111536 · Metasurg · HWC · Jul 21, 2011 · Orthopedic

Device Facts

• Record ID: K111536
• Device Name: METASURG DIGIFUSE IMPLANT
• Applicant: Metasurg
• Product Code: HWC · Orthopedic
• Decision Date: Jul 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. · Hammer toe deformity · Claw toe deformity · Mallet toe deformity · Other deformities of the feet and hands The Metasurg DigiFuse implants are intended for single use only.

Device Story

Metasurg DigiFuse Implant is a one-piece threaded intramedullary bone fastener; manufactured from titanium alloy (Ti 6Al-4V ELI). Device implanted into medullary bone of lesser digits to provide fixation during osteotomy or reconstruction procedures. Available in four variations combining 2.0mm/2.5mm threads and 0°/10° blades. Intended for single use. Used by surgeons in clinical settings to correct toe and finger deformities; stabilizes bone segments to facilitate healing and structural alignment.

Clinical Evidence

Bench testing only.

Technological Characteristics

One-piece threaded intramedullary bone fastener. Material: Titanium Alloy (Ti 6Al-4V ELI). Variations: 2.0mm and 2.5mm thread diameters; 0° and 10° blade angles. Mechanical fixation device.

Indications for Use

Indicated for fixation of osteotomies and reconstruction of lesser phalanges in patients with toe and finger deformities, including hammer toe, claw toe, and mallet toe.

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

• OsteoMed Ext. 2.0/2.4 Cannulated Screw System (K062863)
• Wright Medical Pro-Toe (K101165)
• NEWDEAL K-Wire (K022599)

Submission Summary (Full Text)

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K111536 1/2

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# 510(k) Summary

JUL 2 1 2011

| Date Prepared: | May 19, 2011 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Metasurg<br>16350 Park Ten Place, Suite 101<br>Houston, TX 77084 |
| Company Contact: | Joshua Scott<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | Metasurg DigiFuse Implant |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21<br>CFR 888.3040, Product Code HWC, Class II) |
| Common Name: | Intramedullary Bone Fastener |
| Predicate Devices: | OsteoMed Ext. 2.0/2.4 Cannulated Screw System (K062863)<br>Wright Medical Pro-Toe (K101165)<br>NEWDEAL K-Wire (K022599) |
| Device Description: | The Metasurg DigiFuse Implant is a one-piece threaded device<br>made of titanium intended to be implanted into the medullary<br>bone of the lesser digits. The implant is offered in 4 variations<br>consisting of the combination of 2.0mm and 2.5mm threads and<br>0° and 10° blades. |
| Intended Usage: | The Metasurg DigiFuse implant is indicated for the fixation of<br>osteotomies and reconstruction of the lesser phalanges during<br>procedures to correct deformities of the toes and fingers.<br>· Hammer toe deformity<br>· Claw toe deformity<br>· Mallet toe deformity<br>· Other deformities of the feet and hands<br>The Metasurg DigiFuse implants are intended for single use only. |
| Material: | Titanium Alloy (Ti 6Al-4V ELI) |

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K1115 36\$\frac{2}{2}\$

- Technological Characteristics: The Metasurg DigiFuse implant and the other legally marketed predicate devices listed in this summary have similar indications, physical dimensions and are constructed of titanium and/or stainless steel.
- A design and dimensional comparison was performed to establish Substantial Equivalence: substantial equivalence to the legally marketed predicate devices listed in this summary.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Metasurg % Mr. Joshua Scott 16350 Park Ten Place Suite 101 Houston, Texas 77084

JUL 2 1 2011

Re: K111536

Trade/Device Name: Metasurg DigiFuse Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 31, 2011 Received: June 2, 2011

Dear Mr. Scott:

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 – Mr. Joshua Scott

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (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/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,

E. Keith

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

Enclosure

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### Indications for Use

## KIII 234

510(k) Number: Pending

Device Name: Metasurg DigiFuse Implant

#### Indications for Use:

The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and . reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.

- Hammer toe deformity �
- Claw toe deformity �
- Mallet toe deformity 0
- Other deformities of the feet and hands �

The Metasurg DigiFuse implants are intended for single use only.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkern
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111536

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