The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Device Description

The Nextremity Solutions 3.4mm FlexFusion™ Fixation implant system consists of a two-part 3.4mm diameter bone fixation implant. The proximal and distal components are provided as a set and as a procedure pack with the necessary surgical site preparation and insertion instruments. The Nextremity Solutions FlexFusion™ Fixation Implant is fabricated from medical grade stainless steel and the design allows the clinician to establish a natural angulation of the fused inter-digital joint.

AI/ML Overview

The sponsor, Nextremity Solutions, LLC, did not provide acceptance criteria and a study to prove that the device meets the acceptance criteria. The 510(k) K110445 outlines that the device is substantially equivalent to the predicate device Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259]; Smooth or threaded bone fixation fasteners, StayFuse™ Fixation implant [510(k) Number K990804]; FlexFusion™ Fixation implant and NEWDEAL K Wire [501(k) K022599]; Memometal Intramedullary Arthrodesis Device [510(k) K070598]. This is based on the following:

Intended Use: The device shares the same intended use.
Basic Design: The device has a similar basic design.
Material: The device is fabricated from medical grade stainless steel, similar to predicate devices.
Size: The device is of comparable size (3.4mm diameter).
Fundamental Technology: The device utilizes similar fundamental technology for bone fixation.

Performance Data:

Mechanical testing was performed for the Nextremity Solutions FlexFusion™ Fixation implant. This testing included:

Pull-out force: To assess the force required to remove the implant from bone.
Driving torque: To evaluate the torque needed to insert the implant.
Torque to failure: To determine the maximum torque the implant can withstand before failure.
Static and dynamic flexion extension resistance: To assess the implant's resistance to bending and movement under different conditions.

In addition to mechanical testing, results from cadaver test labs were also presented to support the performance of the device.

No information was provided regarding:

A table of acceptance criteria and the reported device performance.
Sample sizes used for any test set or data provenance.
The number of experts used to establish ground truth or their qualifications.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone performance studies (i.e., algorithm only without human-in-the-loop performance).
The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
The sample size for any training set.
How ground truth for any training set was established.

Summary

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K110445

MAR 1 7 2011

510(k) Summary (Per 21 CFR 807.92)

General Company Information:

Nextremity Solutions, LLC Arthur A. Alfaro President/CEO 167 Stone Hill Road Colts Neck, NJ 07722 Phone: (732) 683-9304 Fax: (732) 683-9476

Date Prepared

March 14, 2011

General Device Information

Product Name:

Classification:

Predicate Device

Arthrex, Inc.

Pioneer Surgical Technology

NewDeal SA

Memometal Technologies, Inc.

Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259]

Smooth or threaded bone fixation fasteners,

StayFuse™ Fixation implant [510(k) Number K990804]

FlexFusion™ Fixation implant

Product code: HWC - Class II

NEWDEAL K Wire [501(k) K022599]

Memometal Intramedullary Arthrodesis Device [510(k) K070598]

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K110445

Description

Intended Use (Indications)

The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Substantial Equivalence

The Nextremity Solutions FlexFusion™ Fixation implant possesses the same technologic characteristics of the predicate devices. These include the intended use, basic design, material, size and fundamental technology.

Performance Data

Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, driving torque, torque to failure, static and dynamic flexion extension resistance. Results from cadaver test labs were also presented.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Nextremity Solutions, LLC % Mr. Arthur A. Alfaro President/CEO 167 Stone Hill Road Colts Neck, New Jersey 07722

MAR 1 7 201

Re: K110445

Trade/Device Name: FlexFusion Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 14, 2011 Reccived: February 16, 2011

Dear Mr. Alfaro:

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

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Page 2 - Mr. Arthur A. Alfaro

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 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.

ff 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/ucm1117800 html br 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" (21CF) 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

My B. D. h
for.

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 Statement

<//o445 510(k) Number (if known):

Device Name: Nextremity Solutions, FlexFusion™ Fixation implant

Indications For Use:

The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Prescription Use (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)

Ar M. Melkerson

) vision Sign-Off) Tyision Surgical, Orthopedic, ind Restorative Devices

K110445
:iG(k) Number

R.1061

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.