N-FORCE FIXATION SYSTEM

K102528 · Innovision, Inc. · HWC · Jul 28, 2011 · Orthopedic

Device Facts

• Record ID: K102528
• Device Name: N-FORCE FIXATION SYSTEM
• Applicant: Innovision, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site: - Beta-bsm (ETEX Corporation) - CarriGen (ETEX Corporation) .

Device Story

N-Force Fixation System is a cannulated, fenestrated screw system for bone fracture fixation and reconstruction. Device serves dual purpose: mechanical stabilization of bone and delivery conduit for ETEX Beta-bsm and CarriGen bone void fillers. Used in surgical settings by orthopedic surgeons. Screws are implanted to provide structural support; fenestrations allow injection of bone void filler material directly to surgical site. Benefits include combined fixation and bone graft delivery in single procedure.

Clinical Evidence

Bench testing only. Mechanical testing included static three-point bending, torsion, axial pullout, insertion torque, and extraction torque. Additional bench testing confirmed the device's ability to deliver bone void filler material compared to predicate delivery systems.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F136. Cannulated and fenestrated screw design. Mechanical fixation via threaded fastener. No software or electronic components.

Indications for Use

Indicated for fixation of bone fractures and bone reconstructions in patients requiring surgical stabilization and/or delivery of bone void fillers (Beta-bsm or CarriGen).

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

• Treu Bone Fixation Screws and Pins (K083912)
• S&N 4.0mm Cannulated Screws (K993106)
• Haig Nail System (K961213 and K991889)
• Delivery systems used with ETEX Beta-bsm and ETEX CarriGen bone void fillers (K101557)

Submission Summary (Full Text)

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## 510(k) Summary

JUL 28 2011

| Contact: | Michelle McDonough<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 21, 2011 |
| Device Trade Name: | N-Force Fixation System |
| Manufacturer: | Innovision, Inc.<br>1975 Nonconnah Blvd.<br>Memphis, TN 38132. |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | HWC |

### Indications For Use:

The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:

- . Beta-bsm (ETEX Corporation)
- CarriGen (ETEX Corporation) .

### Device Description:

The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments.

The N-Force Fixation System screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The N-Force Fixation System is cannulated and fenestrated which allow it to be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.

### Predicate Devices:

The N-Force Fixation System was shown to be substantially equivalent to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mm Cannulated Screws (K993106); the Haig Nail System (K961213 and K991889) which, like the

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N-Force Screw, is a fracture fixation device that temporarily serves as a surgical instrument; and the delivery systems used with ETEX Beta-bsm and ETEX CarriGen bone void fillers (K101557).

### Substantial Equivalence:

Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate devices. Mechanical testing of the screw included static three-point bending, torsion, axial pullout, insertion torque, and extraction torque. Additional testing was performed to demonstrate the substantial equivalence of the N-Force Fixation System to the ETEX recommended instruments with respect to their ability to deliver bone void filler material.

#### Conclusion

The N-Force Fixation System is substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.

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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 consists of a stylized depiction of an eagle or bird-like figure, with its wings spread and head turned to the right. The bird is rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Innovision, Inc. % Ms. Michelle McDonough 1331 H Steet Northwest, 12th Floor Washington, District Columbia 20005

JUL 28 2011

Re: K102528

Trade/Device Name: N-Force Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 16, 2011 Received: June 20, 2011

Dear Ms. McDonough:

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. Iisting 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 - Ms. Michelle McDonough

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 vours.

Mark A. Millener,

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 (if known): K102528

Device Name: N-Force Fixation System

The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:

- Beta-bsm (ETEX Corporation) .
- CarriGen (ETEX Corporation) .

Prescription Use ﮯ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ar M. Melkerson

(Division Sign-Oft) (Division Sign-On))
Division of Surgical, Orthopedic, Division of Surge
and Restorative Devices

510(k) Number K102528

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