The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

Device Description

The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. The implants and instruments of the system are provided sterile for single use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nextra® PEEK Hammertoe Correction System, based on the provided FDA 510(k) summary:

This device did not undergo clinical testing to demonstrate substantial equivalence. Instead, the submission relies on non-clinical testing to compare its performance to predicate devices. This means that many of the typical elements of an AI/medical device performance study (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Threshold)	Reported Device Performance
Biocompatibility	Endotoxin limit of ≤ 20 EU per device (according to AAMI ST72, USP 161, USP 85)	Results met the Endotoxin limit of ≤ 20 EU per device.
Mechanical Strength	Substantially equivalent strength to predicate devices for intended use (according to ASTM F2193-18a)	Confirmed that the strength is substantially equivalent to predicate devices with similar indications and is adequate for its intended use through static and dynamic 3-point bend tests.

2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for the non-clinical tests beyond "worst-case implant construct" for mechanical testing. Data provenance is not applicable as this was non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical testing (like material properties and mechanical strength) is established through standardized testing procedures and material specifications, not expert interpretation.

4. Adjudication method for the test set
Not applicable.

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
No, a multi-reader multi-case comparative effectiveness study was not done. This device is an implant, not an AI-assisted diagnostic or treatment planning tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation was based on:

Standardized Endotoxin Limits: Defined by AAMI ST72, USP 161, and USP 85.
Standardized Mechanical Testing Protocols: Defined by ASTM F2193-18a and comparison to the mechanical properties of legally marketed predicate devices.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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September 23, 2021

Nextremity Solutions. Inc. Elise Fox Quality and Regulatory Specialist 1195 Polk Drive Warsaw, Indiana 46582

Re: K211996

Trade/Device Name: Nexta® PEEK 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 24, 2021 Received: June 28, 2021

Dear Elise Fox:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K211996

Device Name Nextra® PEEK Hammertoe Correction System

Indications for Use (Describe)

The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary
Prepared:	September 22, 2021
Submitter:	Nextremity Solutions, Inc.1195 Polk DriveWarsaw, IN 46582
Contact:	Elise FoxQuality and Regulatory Specialistelise.fox@nextremity.comPhone: 574-376-2062FAX: 574-966-1396
Proprietary Name:	Nextra PEEK Hammertoe Correction System
Common Name:	Bone Screw System
Classification:	21 CFR § 888.3040 Smooth or threaded metallic bone fixation fastener;Class II
Product Code:	HWC

Substantially Equivalent Devices:

Nextremity Solutions, Nextra CH Cannulated Hammertoe System (Cleared as DuoHex™ . CH Cannulated Hammertoe System), K200840-Primary Predicate
. Smith & Nephew, Hat-Trick Lesser Toe Repair System PIP Fusion (Cleared as MTP Solutions LLC, PEEK Fusion Implant), K133515-Additional Predicate
Arthrex, TRIM-IT Spin Pin (Cleared as Arthrex Bio-Pin), K050259-Additional Predicate ●

Device Description:

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Intended Use / Indications:

The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

Summary of Technologies/Substantial Equivalence:

The Nextra PEEK Hammertoe Correction System is substantially equivalent to the predicate devices regarding the intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.

Non-Clinical Testing:

Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device. To evaluate the strength of the Nextra PEEK Hammertoe Correction System and components, static 3-point bend tests and dynamic 3-point bend tests were performed on the worst case implant construct according to ASTM F2193-18a. These tests confirmed that the strength of the Nextra PEEK Hammertoe Correction System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra PEEK Hammertoe Correction System to the predicate device.

Conclusions/Substantial Equivalence:

The Nextra PEEK Hammertoe Correction System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.

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.