Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:

Ø5.0mm compressive screw:

Os Calcis and talar fractures
Calcaneus osteotomies
Arthrodesis of the tarsals

Ø7.0mm compressive screw:

Ankle arthrodesis
Calcaneus osteotomies

Device Description

Nexis® is a range of osteosynthesis compressive single use screws, made of titanium alloy, designed to address foot and ankle indications. These devices are designed for stable fixation and have quick insertion features.

They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.

AI/ML Overview

This FDA 510(k) premarket notification summary for the Nexis® compressive screws describes non-clinical testing to demonstrate substantial equivalence to predicate devices. It does not involve AI or algorithms, and therefore, an analysis of the device's performance based on AI/ML criteria is not applicable. The provided document focuses on mechanical and biological properties of the screws.

Here's an analysis of the available information regarding acceptance criteria and the study (non-clinical) that proves the device meets them:

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

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Torsion Resistance	Prevent screw breakage during insertion/removal (evaluated against predicate device)	Performed according to ASTM F543-17 and evaluated against a predicate device. (Specific values not provided, but deemed acceptable by equivalence)
Strength (Insertion/Removal)	Avoid failure of the screw during insertion or removal	Performed according to ASTM F543-17. (Specific values not provided, but deemed acceptable by equivalence)
Axial Pull-out Resistance	Valid suitable anchorage when subjected to tensile forces, poor bone quality, or osteoporotic bone	Assessed using the equation described by Chapman et al., 1996. (Specific values not provided, but deemed acceptable by equivalence)
Sterilization and Reprocessing	Cleanliness and sterility of the device and instruments, sterility assurance level of 10-6	Performed according to ISO 11137-1, ISO 11607-1, and ISO 11607-2. (Specific results not provided, but deemed acceptable)
Biocompatibility	Device is biocompatible for implantable use	Assessed using ISO 10993-1:2018. (Specific results not provided, but deemed acceptable)

Notes on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to predicate devices through established industry standards (ASTM, ISO) and relevant guidance (FDA Guidance "orthopedic non-Spinal metallic bone screw and washers – Performance Criteria for safety and Performance based pathway"). The specific quantitative acceptance criteria (e.g., minimum torque values, pull-out strength in Newtons) are not explicitly stated in this summary but would have been defined within the full test reports submitted to the FDA and would align with the predicate device's performance or standard requirements.

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 for Test Set: Not explicitly stated for each test. The testing involved various mechanical and biological evaluations of the screws. Typically, mechanical testing involves a statistically relevant number of samples to ensure reproducibility and confidence in results (e.g., 5-10 samples per test condition), but this detail is omitted from the summary.
Data Provenance: The studies are non-clinical, so "country of origin of the data" in the sense of patient data is not applicable. The testing was performed in the context of the manufacturer (Novastep® S.A.S.) who is based in France. The studies are by nature prospective, as they are conducted specifically to support the 510(k) submission.

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 is a medical device (screw) clearance based on mechanical, material, and biological properties, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth from medical images or patient data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in diagnostic or screening contexts, often with images. This submission is for a physical orthopedic implant and does not involve such an adjudication process.

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 is not an AI/ML-driven device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

Not applicable. This is not an AI/ML-driven device or an algorithm.

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

Not applicable. For this type of device, "ground truth" is established through engineering principles, material science, and conformance to recognized standards (e.g., ASTM, ISO), rather than medical consensus or clinical outcomes data. The performance of the device itself (e.g., its strength, sterility, biocompatibility) is the "ground truth" being assessed against predefined engineering and quality specifications.

8. The sample size for the training set

Not applicable. This involves non-clinical testing of physical devices, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted in point 8, there is no training set for an AI/ML algorithm in this submission.

Summary

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August 30, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Novastep Gilles Audic QA/RA director 2. allée Jacques Frimot Rennes. 350000 France

Re: K223468

Trade/Device Name: Nexis® compressive screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 1, 2023 Received: August 1, 2023

Dear Gilles Audic:

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.

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

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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 mediation-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 -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223468

Device Name Nexis® compressive screws

Indications for Use (Describe)

Ø5.0mm compressive screw:

Os Calcis and talar fractures
Calcaneus osteotomies
Arthrodesis of the tarsals

Ø7.0mm compressive screw:

Ankle arthrodesis
Calcaneus osteotomies

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

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Nexis® compressive screws.

SUBMITTER/510(K) HOLDER

Novastep® S.A.S 2, Allée Jacques Frimot 35000 Rennes France Phone: +33-2-99-33-86-50

Gilles Audic, Quality Affairs / Regulatory Affairs Director Contact: Contact Phone: +33-6-30-93-96-08 gilles.audic@novastep-ortho.com Contact Email: Date Prepared: November 17, 2022

DEVICE NAME

Device name:	Nexis® compressive screws
Device Classification Name:	Screw, fixation, bone
Regulation Number:	888.3040
Classification Product Code:	HWC
Device Class:	Class II

PREDICATE DEVICE

Primary Predicate

Manufacturer:	Stryker Trauma AG
Device name:	FIXOS SCREW SYSTEM
Device Classification Name:	Screw, fixation, bone
510(k) Number:	K133451
Regulation Number:	888.3040
Classification Product Code:	HWC
Device Class:	Class II

Additional Predicate

Manufacturer:	WRIGHT MEDICAL TECHNOLOGY, INC.
Device name:	DARCO HEADLESS COMPRESSION SCREW
Device Classification Name:	Screw, fixation, bone
510(k) Number:	K080850
Regulation Number:	888.3040
Classification Product Code:	HWC
Device Class:	Class II

Additional Predicate

Manufacturer:	Novastep® S.A.S
Device name:	Nexis osteosynthesis compressive screw
Device Classification Name:	Screw, fixation, bone
510(k) Number:	K143229
Regulation Number:	888.3040
Classification Product Code:	HWC
Device Class:	Class II

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DEVICE DESCRIPTION

They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.

INTENDED USE/INDICATION FOR USE

The intended use is:

. Osteosynthesis compressive screw
The indication for use is:
그 Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:
Ø5.0mm compressive screw:
Os Calcis and talar fractures o
Calcaneus osteotomies O
Arthrodesis of the tarsals O

Ø7.0mm compressive screw:

o Ankle arthrodesis
Calcaneus osteotomies o

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

Novastep® S.A.S. demonstrated that Nexis® compressive screws are substantially equivalent to the predicate devices, FIXOS SCREW SYSTEM (primary predicate device, K133451, cleared 28-Feb-2014) in term of intended use (including indication for use) and performance, DARCO HEADLESS COMPRESSION SCREW (additional predicate device, K080850, cleared 04-Oct-2008) in term of design characteristics and Nexis osteosynthesis compressive screws (secondary predicate device, K143229, cleared 02-Jun-2015) in term of the safety of the device, with equivalence on raw material, manufacturing process and biocompatibility. The subject device indications for use, technological characteristics and overall design are substantially equivalent to those of the predicate devices. Any minor differences in design and performance do not raise any questions of safety or effectiveness.

SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Nexis® compressive screws have undergone functional testing to provide evidence that its non-clinical properties are substantially equivalent to predicate devices already cleared.

Functional tests have been done according to the FDA Guidance "orthopedic non-Spinal metallic bone screw and washers – Performance Criteria for safety and Performance based pathway" issued December 11, 2021:

Torsion resistance of the screws must be assessed to prevent screw breakage during insertion or removal. -Test performed according to ASTM F543-17 and evaluated against a predicate device.
-Strength needed to insert and remove screws must be evaluated to avoid failure of the screw during insertion or the removal.
- Tests performed according to ASTM F543-17.
-Axial pull out resistance of the screws must be assessed to valid a suitable anchorage when subjected to tensile forces, poor bone quality or osteoporotic bone.
- Assessed using the equation described by Chapman et al., 1996.
-Sterilization and reprocessing validations to demonstrate the cleanliness and the sterility of, and the ability to clean and sterility assurance level of 10th, the device and device-specific instruments.

Tests performed according to ISO 11137-1, ISO 11607-1 and ISO 11607-2.

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Biocompatibility of the device. -Assessed using ISO 10993-1: 2018.

SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Not applicable. Clinical studies were not required for this submission.

CONCLUSIONS

Nexis® compressive screws are substantially equivalent to the predicate devices, FIXOS SCREW SYSTEM (K133451, cleared 28-Feb-2014) in term of intended use and performance, DARCO HEADLESS COMPRESSION SCREW (K080850, cleared 04-Oct-2008) in terms design and Nexis osteosynthesis compressive screws (K143229, cleared 02-Jun-2015) in terms of material, manufacturing process and biocompatibility. Any minor differences between these devices do not raise new questions of safety and effectiveness.

Regulation Number and Section

N/A