FORCE MEDICAL IM NAIL SYSTEM

K102577 · Force Medical, Inc. · HSB · May 3, 2012 · Orthopedic

Device Facts

• Record ID: K102577
• Device Name: FORCE MEDICAL IM NAIL SYSTEM
• Applicant: Force Medical, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: May 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.

Device Story

Force Medical IM Nail System is a cannulated, intramedullary fixation device used for tibiotalocalcaneal arthrodesis and hindfoot stabilization. System includes angled and straight nails in various diameters and lengths, transverse locking cortical/cancellous bone screws, and endcaps for length extension. Device is manufactured from high-strength 6-4 titanium alloy. Surgeons use provided guide/placement instrumentation under x-ray fluoroscopy to ensure accurate nail and screw alignment. Device provides mechanical stability to the ankle and hindfoot joints, facilitating bone fusion and correcting deformities. It is intended for use in clinical settings by orthopedic surgeons.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Cannulated intramedullary nail; material: High Strength 6-4 Titanium Alloy (ASTM F136); surface treatment: Type II anodize; color-coded for left/right versions; includes titanium alloy transverse locking screws, endcaps, and compression washers; mechanical fixation; manual instrumentation for placement under fluoroscopy.

Indications for Use

Indicated for patients requiring hindfoot/ankle stabilization or fusion due to posttraumatic/primary arthrosis, neuromuscular deformity, revision of failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuroarthropathy (Charcot), rheumatoid arthritis with severe deformity, osteoarthritis, or pseudarthrosis.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Stryker - T2 Ankle Arthrodesis Nail (K051590, K020384)
• Biomet - Phoenix Nail Systems (K091976, K081243)
• Wright Medical - Valor Ankle Fusion Nail (K110552)

Submission Summary (Full Text)

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### Section XII: 510(k) Summary of Safety and Effectiveness

MAY - 3 2012

:

# SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

| NAME OF FIRM: | Force Medical, Inc.<br>13566 Freeport Road<br>San Diego, CA 92129 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott<br>BioMedical Engineer<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372<br>[e-mail] |
| DATE: | August 20, 2010 |
| TRADE NAME: | Force Medical IM Nail System |
| COMMON NAME: | Intramedullary Nail |
| CLASSIFICATION: | Intramedullary fixation rod (see 21CFR, Sec. 888.3020)<br>Single/Multiple component metallic bone fixation appliances and<br>accesories. (See 21CFR, Sec. 888.3030) |
| DEVICE PRODUCT CODE: | HSB |
| SUBSEQUENT PRODUCT CODE: | JDS |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Stryker - T2 Ankle Arthrodesis Nail (K051590, K020384)<br>Biomet - Phoenix Nail Systems (K091976, K081243)<br>Wright Medical - Valor Ankle Fusion Nail (K110552) |
| DEVICE DESCRIPTION: | The Force Medical IM Nail System is an angled (left & right) and<br>straight (left & right due to hole orientation), cannulated,<br>intramedullary nail in multiple diameters(8) and in multiple lengths(3)<br>manufactured from High Strength 6-4 Titanium Alloy to ASTM F136.<br>The nail features proximal, distal, and midshaft angled hole(s) to<br>receive Alloyed Titanium transverse locking 4.5mm Cortical and<br>4.5/6.5 Transition Cortical - Cancellous Bone Screws (in various<br>lengths). Endcaps (in 0+ and 6 lengths in 4 diameters) in the Titanium<br>Alloy are available for nail end bottom screw locking and IM Nail<br>length extension. A Titanium Alloy Compression Washer and Screw<br>(in 5 lengths) is also available for joint compression(s) if distal<br>talocalcaneal fusion is required. All alloyed titanium components have<br>a Type II anodize surface treatment and are anodize color coded for<br>left/right versions. A full set of guide/placement instrumentation is<br>available for accurate placement and alignment of the bone screws<br>within the nail when used in conjuction with x-ray fluoroscopy. The<br> |

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#### INTENDED USE:

The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.

## Indications for use include:

- Posttraumatic and primary Arthrosis a
- Neuromuscular deformity A
- Revision of Failed Ankle Arthrodesis A
- Failed Total Ankle Replacement a
- Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) A
- A Neuroarthropathy (Charcot)
- Rheumatoid Arthritis with severe deformity A
- Osteoarthritis A
- Pseudarthrosis A

BASIS OF SUBSTANTIAL EQUIVALENCY:

The Force Medical IM Nail System is substantially equivalent to predicate devices from Stryker, Biomet, and Wright Medical.

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The Force Medical IM Nail System is substantially equivalent in Material, Geometry Design/Markings, and Indications to the many predicate systems marketed and sold in the U.S..

#### SUMMARY OF SAFETY AND EFFECTIVENESS:

The Force Medical IM Nail System is shown to be safe and effective for use in IM Nail ankle fusion procedures where stability and precision placement is required.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

Force Medical, Incorporated % Engineering Consulting Services, Incorporated Mr. Al Lippincott Biomedical Engineer 3150 East 200th Street Prior Lake, Minnesota 55372

MAY - 3 2012

Re: K102577

Trade/Device Name: Force Medical IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDS Dated: April 10, 2012 Received: April 27, 2012

Dear Mr. Lippincott:

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 or uny I vith 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. Al Lippincott

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Peter Der Dr.

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

## 510(k) NUMBER: K102577

## DEVICE NAME: Force Medcial IM Nail System

The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.

#### Indications for use include:

- Posttraumatic and primary Arthrosis A
- Neuromuscular deformity A
- Revision of Failed Ankle Arthrodesis A
- Failed Total Ankle Replacement A
- Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) A
- A Neuroarthropathy (Charcot)
- Rheumatoid Arthritis with severe deformity >
- Osteoarthritis A
- Pseudarthrosis A

Ast

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

KID2577 510(k) Number __

× Prescription Use

AND/OR

Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)