XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM

K121417 · Extremity Medical, LLC · HWC · Jul 18, 2012 · Orthopedic

Device Facts

• Record ID: K121417
• Device Name: XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.

Device Story

Extremity Medical Screw System consists of metallic bone fixation fasteners; used for arthrodesis of specific foot and hand joints (metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal). Device provides mechanical stabilization of bone segments to facilitate fusion. Operated by surgeons in clinical/surgical settings. Output is physical fixation of bone joints; aids in stabilization and healing. Benefits include joint immobilization and fusion.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing (pull-out strength and torque) and cadaveric clinical simulations to verify surgical technique.

Technological Characteristics

Metallic bone fixation fastener; smooth or threaded design. Materials are similar to predicate devices. Mechanical properties verified via bench testing.

Indications for Use

Indicated for fixation arthrodesis of metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.

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

• EXTREMITY MEDICAL Screw System (K093770)
• EXTREMITY MEDICAL Screw System (K091577)
• EXTREMITY MEDICAL Midfoot Screw System (K082934)

Submission Summary (Full Text)

{0}------------------------------------------------

Special 510(k) Summary of Safety and Effectiveness:

. ..

ﻣﻌﺘﺎﺩ: ﻣﻌﺪ

ﻬﺎ

prop

# EXTREMITY MEDICAL Screw System

<121417

JUL 1 8 2012

- --

·

... ...

11 |

| Submitter: | EXTREMITY MEDICAL. LLC<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe<br>President<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | June 19, 2012 |
| Trade Name | EXTREMITY MEDICAL Screw System |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. EXTREMITY MEDICAL Screw System, Extremity Medical K093770<br>2. EXTREMITY MEDICAL Screw System, Extremity Medical K091577<br>3. EXTREMITY MEDICAL Midfoot Screw System, Extremity Medical K082934 |
| Device Description | The EXTREMITY MEDICAL Screw System |
| Indications for use | "The Extremity Medical Screw System is intended for fixation arthrodesis of the<br>metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular,<br>calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints." |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL Screw System and its predicate devices have the<br>same indications for use; have a similar design; are made of similar materials,<br>and have equivalent mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out strength and torque was performed and<br>compared to the predicate devices. Clinical simulations in cadavers were<br>performed to verify the surgical technique. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The EXTREMITY MEDICAL Screw System is substantially equivalent to its<br>predicate devices. This conclusion is based upon indications for use, materials,<br>design, test data and principles of operation. |

53

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

Extremity Medical, LLC % Mr. Jamy Gannoe Chief Executive Officer and President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K121417

Trade/Device Name: Extremity Medical Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 27, 2012 Received: June 28, 2012

Dear Mr. Gannoe:

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

JUL 1 8 2012

{2}------------------------------------------------

### Page 2- Mr. Jamy Gannoe

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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunice Keith

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

Enclosure

{3}------------------------------------------------

\$\leftarrow\$121417

Special 510(k) Premarket Notification

## Indications for Use

510(k) Number (if known): Device Name:

Indications for Use:

EXTREMITY MEDICAL Screw System

The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.

Over-the-counter Prescription Use X AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asht

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k121417