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 fixation. It includes fully and partially cannulated screws in various diameters and lengths, and accompanying instruments.
The N-Force Fixation System implants are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136. The N-Force Fixation System screws are cannulated and/or fenestrated and can be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.

AI/ML Overview

The document describes a Special 510(k) submission for the N-Force Fixation System, a screw system intended for bone fracture fixation and reconstruction, which can also deliver bone void fillers. The submission seeks to add new sizes and components to the existing system. The key information is about demonstrating substantial equivalence to a predicate device (K102528).

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (What was tested)	Reported Device Performance (Results)
Static three-point bending	Demonstrated substantial equivalence to the predicate N-Force Screw
Static torsion	Demonstrated substantial equivalence to the predicate N-Force Screw
Extraction testing	Demonstrated substantial equivalence to the predicate N-Force Screw
Engineering analyses (non-fenestrated screws)	Supported substantial equivalence
Ability to deliver bone void filler material (with ETEX recommended instruments)	Demonstrated substantial equivalence to the predicate N-Force Fixation System

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The document mentions "Testing was performed on the modified N-Force Screw" without specifying the number of screws or tests conducted.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. The testing was performed by the manufacturer, InnoVision, Inc., which is based in Memphis, TN, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This device is a mechanical fixation system, and its performance testing involves mechanical stability tests (bending, torsion, extraction) rather than expert interpretation of images or clinical outcomes that would require a "ground truth" established by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As explained above, the testing is mechanical and does not involve adjudication of expert opinions.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device (screw fixation system), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm. The "standalone" performance here refers to the device's mechanical properties. The studies described are essentially "standalone" device performance tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on established mechanical engineering principles and standards for bone fixation devices. The tests (static three-point bending, static torsion, extraction testing) are designed to assess the physical properties and strength of the screws against predefined engineering requirements and in comparison to a predicate device.
The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm. Therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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MAR 0 6 2014

510(k) Summary 5

、

Contact:	Michelle McDonoughMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	March 6, 2014
Device Trade Name:	N-Force Fixation System
Manufacturer:	InnoVision, Inc.1975 Nonconnah BoulevardMemphis, TN 38132
Common Name:	Smooth or threaded metallic bone fixation fastener
Classification:	21 CFR 888.3040
Class:	II
Product Code:	HWC

Reason for Special 510(k) Submission:

The purpose of this Special 510(k) is to add new sizes and components to the N-Force Fixation System. There have been no changes to the intended use of the device or its fundamental scientific technology.

Indications For Use:

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

Device Description:

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

The N-Force Fixation System implants are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136. The N-Force Fixation System screws are cannulated and/or

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fenestrated and can be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.

Predicate Device:

The modified N-Force Fixation System is substantially equivalent to the predicate N-Force Fixation System (K102528) with respect to indications, design, function, performance and materials.

Substantial Equivalence:

Testing was performed on the modified N-Force Screw compared to the predicate N-Force Screw, and the results demonstrate that it is substantially equivalent to the predicate device. Mechanical testing of the modified screw included static three-point bending, static torsion and extraction testing, Engineering analyses were also provided in support of the non-fenestrated screws' substantial equivalence. 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.

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Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting a globe or other object.

Public Health Service

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

March 6, 2014

InnoVision, Inc. % Ms. Michelle McDonough Senior Associate, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street NW 12th Floor Washington, District of Columbia 20005

Re: K132244

Trade/Device Name: N-Force Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 5, 2014 Received: February 6, 2014

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, 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 - 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Vincent同@evlin -S

for
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 4

510(k) Number (if known): K132244

Device Name: N-Force Fixation System

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

Prescription Use V (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L.購ank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.