EXTREMITY MEDICAL IP FUSION SYSTEM

K130120 · Extremity Medical, LLC · HWC · Apr 11, 2013 · Orthopedic

Device Facts

• Record ID: K130120
• Device Name: EXTREMITY MEDICAL IP FUSION SYSTEM
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Apr 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.

Device Story

The Extremity Medical IP Fusion System is an orthopedic implant set designed for arthrodesis of hand interphalangeal joints. The system comprises a cannulated or non-cannulated lag screw and an intramedullary post; the post is a threaded cylinder with an eyelet that couples with the lag screw at an oblique angle to establish a specific fusion reference angle. The system includes surgical instrumentation such as drills, guide wires, countersinks, reamers, and screwdrivers. It is intended for use by surgeons in a clinical or operating room setting to achieve bone fixation. The device provides mechanical stability to facilitate joint fusion, potentially improving patient outcomes in hand surgery.

Clinical Evidence

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

Technological Characteristics

Metallic bone fixation fastener system. Components include cannulated/non-cannulated lag screws and intramedullary posts. Materials are metallic (specific alloys not detailed). System utilizes mechanical fixation via threaded components and oblique coupling. No software or electronic components.

Indications for Use

Indicated for reduction and internal fixation of arthrodesis of the interphalangeal joints of the 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

• Kirschner Wires (K073674)
• Osteomed Hand Fusion System (K111419)
• EXTREMITY MEDICAL Screw System (K121417)

Submission Summary (Full Text)

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K130120

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# 510(k) Summary of Safety and Effectiveness:

### EXTREMITY MEDICAL IP Fusion System

APR 1 1 2013

| Submitter: | EXTREMITY MEDICAL<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal<br>Director, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | March 26, 2013 |
| Trade Name | EXTREMITY MEDICAL IP Fusion System |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. Kirschner Wires K073674<br>2. Osteomed Hand Fusion System K111419<br>3. EXTREMITY MEDICAL Screw System, Extremity Medical K121417 |
| Device Description | The Extremity Medical IP Fusion System is designed to allow arthrodesis of<br>the interphalangeal joints of the hand. The system has two intra-operative<br>configurations: a cannulated or non-cannulated lag screw, and an<br>intramedullary Post for engaging the lag screw. The Post consists of a threaded<br>cylinder with an eyelet through the head at to accommodate the lag screw. The<br>axis of the eyelet and the lag screw couple at an oblique angle, which forms a<br>reference angle for the intended fusion. The system includes common<br>instrumentation for application of surgical bone screws within the human<br>body, such as drills, guide wires, countersinks, reamers, drill and guide wire<br>guides, and a screwdriver. |
| Indications for use | The Extremity Medical IP Fusion System is intended for reduction and internal<br>fixation of arthrodesis of the interphalangeal joints of the hand. |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL IP Fusion System and its predicate devices<br>have the same indications for use; have a similar design; are made of similar<br>materials, and have equivalent mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out strength, torque, and static and dynamic<br>bending was performed and compared to the predicate devices. Clinical |
| | simulations in cadavers were performed to verify the surgical technique. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The EXTREMITY MEDICAL IP Fusion System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation. |

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K130120

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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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle emblem, consisting of three curved lines that resemble the wings and body of an eagle.

Public Health Service

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

Letter dated: April 11, 2013

Extremity Medical, LLC. % Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K130120

Trade/Device Name: EXTREMITY MEDICAL IP Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 28, 2013 Received: January 30, 2013

Dear Mr. Smekal:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 – Mr. Brian Smekal

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,

## Mark N. Melkerson -S

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

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### Indications for Use

510(k) Number (if known): K130120 EXTREMITY MEDICAL IP Fusion System Device Name: Indications for Use:

The Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth Lygrank -S

Division of Orthopedic Devices