The Nextremity Solutions Nextra™ Ti Hammertoe Correction (Nextra) System consists of proximal and distal components provided as a set with the necessary surgical site preparation and insertion instruments in a procedure pack. Nextra is fabricated from medical grade titanium alloy (6Al-4V) and the design allows the clinician to establish a natural angulation of the fused interdigital joint.

AI/ML Overview

The provided text describes mechanical testing for the Nextra™ Ti Hammertoe Correction System. However, it does not include the specific acceptance criteria or detailed results of that testing. It simply states that "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."

Therefore, based on the provided input, I cannot answer most of your questions as the necessary information is not present.

Here's what I can provide based on the given text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text.	Mechanical testing was performed for pull-out force, driving torque, torque to failure, static and dynamic flexion extension resistance. Specific performance values and whether they met acceptance criteria are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This was mechanical testing, so "provenance" might refer to the lab conducting the tests.

3. 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 was mechanical testing, not a study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was mechanical testing.

5. 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 was mechanical testing of a bone fixation device, not an AI-assisted diagnostic tool or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This was mechanical testing of a bone fixation device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the conventional sense for mechanical testing. The "ground truth" would be the engineering specifications and recognized testing standards (e.g., ISO, ASTM) against which the device's mechanical properties are measured.

8. The sample size for the training set

Not applicable. This was mechanical testing, not a machine learning study with a training set.

9. How the ground truth for the training set was established

Not applicable. This was mechanical testing, not a machine learning study.

Summary

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K122031 *#1/2

510(k) Summary (Per 21 CFR 807.92)

General Company Information:

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

Date Prepared

July 9, 2012

General Device Information

Product Name:

Classification:

Smooth or threaded bone fixation fasteners, Product code: HWC - Class II

Nextra™ Ti Hammertoe Correction System

Predicate Devices

Nextremity Solutions, LLC

FlexFusion™ Fixation implant [510(k) K110445]

Arthrex, Inc.

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

Description

Intended Use (Indications)

The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

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K122031 #2/a

Substantial Equivalence

The Nextra™ Ti Hammertoe Correction System possesses the same technologic characteristics of the predicate devices. These characteristics 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

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

OCT

9 2012

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

Re: K122031

Trade/Device Name: Nextra™ Ti Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 9, 2012 Received: June 11, 2012

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 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. Arthur A. Alfaro

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

Sincerely yours,

Einal Keith

/ 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

510(k) Number (if known): K | 2 d 0 3 |

Device Name: Nextremity Solutions, Nextra™ Ti Hammertoe Correction System

Indications For Use:

The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Prescription Use X (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)

Ash

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.