The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Device Description

The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another allowing for reduction and fixation of the bone fragments.

AI/ML Overview

The PEEK Fusion Implant underwent non-clinical performance testing to ensure its substantial equivalence to predicate devices and its intended performance.

Acceptance Criteria and Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Tensile Strength Testing	The device should demonstrate comparable tensile strength to the predicate device.	Equivalent time zero tensile strength compared to the predicate.
Bending Strength Testing	The device should demonstrate comparable or greater bending strength compared to the predicate device.	Greater bending strength compared to the predicate.
Torsion Strength Testing	The device should demonstrate comparable or greater torsional strength compared to the predicate device.	Greater torsional strength compared to the predicate.
Shear Strength Testing	The device should demonstrate comparable or greater shear strength compared to the predicate device.	Greater shear strength compared to the predicate.
Screw Insertion Testing	Not explicitly stated as a pass/fail criterion in the provided text, but implied as part of demonstrating functional performance.	Implied successful insertion with adequate torque, as driver torque failure loads exceeded required insertion torque.
Driver Torque to Failure Testing	The driver/implant interface torque failure loads should exceed the torque required to insert the implants.	Driver/implant interface torque failure loads exceeded the torque required to insert the implants.
Association & Disassociation Testing	No disassociation of the implants should be observed during fatigue testing.	No disassociation of the implants was observed during fatigue testing.
Four-point Bending Fatigue Testing	The device should demonstrate comparable fatigue performance to the predicate device.	Equivalent fatigue performance compared to the predicate.
Tensile Load after Fatigue Testing	The device should demonstrate comparable or greater tensile strength after undergoing fatigue testing when compared to the predicate.	Greater post-fatigue tensile strength compared to the predicate.

Study Details:

Sample Size for Test Set and Data Provenance:
- The document states that "All testing was performed on test units representative of finished devices." However, the specific sample size for each mechanical test (e.g., number of implants tested for tensile strength) is not provided.
- The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, MTP Solutions LLC. There is no information regarding country of origin, but it is implied to be within the scope of the manufacturer's operations. The testing is described as pre-clinical and therefore inherently retrospective in the context of device design and validation.
Number of Experts and Qualifications for Ground Truth:
- This is a non-clinical mechanical testing study, not a clinical study involving expert assessment of patient data. Therefore, the concept of "experts used to establish ground truth" related to clinical interpretation or diagnosis does not apply. The "ground truth" here is the objective measurement of mechanical properties of the device and its predicates.
Adjudication Method:
- Not applicable as this is a non-clinical mechanical testing study, not a study requiring adjudication of clinical observations or diagnoses. The results are based on objective measurement of physical properties.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This document describes non-clinical mechanical testing of an implantable device, not an AI-assisted diagnostic or interpretive system that would typically use MRMC studies.
Standalone (Algorithm Only) Performance:
- Not applicable. This document describes a physical medical device (an implant), not a software algorithm or AI. Therefore, standalone algorithm performance is not relevant.
Type of Ground Truth Used:
- The ground truth for the performance claims derived directly from objective physical measurements and mechanical testing data (e.g., force, torque, displacement) as specified in the various tests (tensile, bending, torsion, fatigue, etc.). This data establishes the inherent properties of the PEEK Fusion Implant and its predicate devices.
Sample Size for Training Set:
- Not applicable. This is a non-clinical mechanical performance study of a physical device. There is no "training set" in the context of machine learning or AI models. The "training" in this context would refer to the engineering design and manufacturing processes, which are not detailed as a "training set" here.
How Ground Truth for Training Set Was Established:
- Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this device. The physical properties being tested are intrinsic to the manufactured device.

Summary

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K133515 Page 1 of 2

510(k) Summary

Device Trade Name:	PEEK Fusion Implant
Manufacturer:	MTP Solutions LLC124 South 600 West, Suite 100Logan, UT 84321
Contact:	Mr. Robert HoyDirector of Technical & Clinical ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@venturemd.com
Prepared by:	Musculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	March 28, 2014
Common Name:	Screw, Fixation, Bone
Classification:	21 CFR 888.3040
Class:	II
Product Code:	HWC

Indications for Use:

The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Device Description:

Predicate Devices:

The PEEK Fusion Implant is substantially equivalent to the Arthrex Bio-Pin (marketed as the Trim-It Pin) [K050259], the OsteoMed ExtremiFuse [K130412] and the Nextremity FlexFusion Implant (marketed as the Nextra) [K110445] with respect to its indications for use, geometry, dimensions, function and performance.

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Technological Characteristics Comparison:

The PEEK Fusion Implant and its predicate devices are similar in size and all generally cylindrical in shape. In addition, all devices are designed to be deployed across osteotomy and reconstruction sites with the purpose of fixing bone fragments. The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) while the Arthrex Bio-Pin predicate is composed of poly (L-lactide); the OsteoMed ExtremiFuse predicate is made from titanium alloy and the Nextremity FlexFusion predicate from stainless steel. All four materials are present in many FDA cleared permanent implants and have a long history of biocompatibility. The biocompatibility of the candidate device material is further substantiated by the data available in an FDA Master File. In addition, mechanical test results demonstrate that the difference in material increases the construct strength as determined in side-by-side testing vs. a predicate device. Therefore, this difference in technology introduces no new issues of safety or effectiveness.

Nonclinical Testing:

Pre-clinical testing has been performed for the PEEK Fusion Implant to assure substantial equivalence to a predicate device and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.

The device design was qualified through the following tests:

. Tensile Strength Testing
Bending Strength Testing .
. Torsion Strength Testing
Shear Strength Testing .
. Screw Insertion Testing
. Driver Torque to Failure Testing
Association & Disassociation Testing .
Four-point Bending Fatigue Testing .
Tensile Load after Fatigue Testing .

The results of this testing demonstrate that the PEEK Fusion Implant performs as intended and has greater bending, torsion, shear and post-fatigue tensile strength and equivalent time zero tensile strength and fatigue performance when compared to the predicate. In addition, the driver/implant interface torque failure loads exceeded the torque required to insert the implants and no disassociation of the implants was observed during fatigue testing.

Conclusion:

The PEEK Fusion Implant met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Indications/Intended Use and the fundamental scientific technology of the PEEK Fusion Implant are similar to those described in the predicate devices. The PEEK Fusion Implant has been determined by MTP Solutions to be substantially equivalent to the Arthrex Bio-Pin (marketed as the Trim-It Pin) [K050259], the OsteoMed ExtremiFuse [K130412] and the Nextremity FlexFusion Implant (marketed as the Nextra) [K110445].

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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 and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

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

March 28, 2014

MTP Solutions LLC Mr. Robert Hoy Director of Technical & Clinical Research 124 South 600 West, Suite 100 Logan, Utah 84321

Re: K133515

Trade/Device Name: PEEK Fusion Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 4, 2014 Received: March 5, 2014

Dear Mr. Hoy:

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. Robert Hoy

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" (21 CFR 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 yours.

Ronald P. Jean -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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4. Indications for Use

510(k) Number (if known): __K133515

Device Name: PEEK Fusion Implant

Indications for Use:

The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

V 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 OF NEEDED)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133515

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.