The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

Device Description

The Activ Fuse range consists of plates and screws designed for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. The system includes a modular plate design for a lateral calcaneal extension. The Activ Fuse range will be provided non-sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

AI/ML Overview

This document is a 510(k) Summary for the Activ Fuse range of orthopedic implants. It describes the device, its intended use, and substantial equivalence to predicate devices, focusing on non-clinical testing. It explicitly states that no clinical studies were performed.

Therefore, it is not possible to provide the requested information regarding:

Acceptance criteria and reported device performance related to a study proving the device meets acceptance criteria. The document refers to engineering analysis and comparative static and dynamic tests, but not to a study with acceptance criteria in the context of AI/software performance or human-in-the-loop studies.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document centers on demonstrating substantial equivalence through non-clinical tests (engineering analysis, mechanical testing) rather than clinical performance or AI/software validation.

Here's a summary of what is available in the document regarding the device's evaluation:

1. Table of acceptance criteria and reported device performance:

The document doesn't present "acceptance criteria" and "reported device performance" in the context of a study proving the device meets the acceptance criteria as typically understood for AI/software or clinical trials. Instead, it discusses the safety and effectiveness of the medical device (implants) based on non-clinical testing.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary)
Mechanical Performance	Static and Dynamic Tests: "The analysis showed that the Activ Fuse range is as safe and as effective as the predicates."
Material Conformance	Material: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3). Same material as predicate devices.
Biocompatibility/Safety	Endotoxin testing: Performed using LAL quantitative kinetic chromogenic method.
Functional Equivalence	Function: The implants are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. (Similar to predicate devices).

2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses mechanical tests of physical devices, not a test set of data.

3. Number of experts used to establish the ground truth... and qualifications: Not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. "No clinical studies were performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical medical device (orthopedic implants), not software/AI.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be the engineering and material specifications, and the results of standardized mechanical tests (e.g., strength, durability, fatigue).

8. The sample size for the training set: Not applicable. There is no training set for a physical implant device.

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

Summary

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November 17, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".

Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc 4313 West 3800 South West Haven, Utah 84401

Re: K202307

Trade/Device Name: Activ Fuse Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS , HWC Dated: August 12, 2020 Received: August 14, 2020

Dear J.D. Webb:

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 (OS) 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, 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) K202307

Device Name Activ Fuse

Indications for Use (Describe)

The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary for the Activ Fuse range

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) Summary is submitted for the Activ Fuse range.

Summary preparation date: July, 2020

1. Submitter:

NEWCLIP TECHNICS P.A. de la Lande Saint Martin 45 rue des Garottières F-44115 Haute-Goulaine - France Telephone: (33) 2 28 21 37 12

Contact Person:

J.D. Webb The OrthoMedix Group, Inc. 4313 West 3800 South West Haven, UT 84401 Telephone: 512-590-5810

1. Trade name: Activ Fuse Common Name: Plate, Fixation, Bone / Screw, Fixation, bone Product code: HRS - Plate, Fixation, Bone HWC - Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories. (21 CFR part. 888.3030) Smooth or threaded metallic bone fixation fastener.(21 CFR part. 888.3040)

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3. Primary predicate or legally marketed devices which are substantially equivalent:

Ortholoc 3Di Ankle Fusion Plating System (K121425) of WRIGHT MEDIAL . TECHNOLOGY INC.

Additional predicate or legally marketed devices which are substantially equivalent:

Ortholoc 3Di Ankle Fusion Plating System (K163650) of WRIGHT MEDIAL . TECHNOLOGY INC.
Ankle Fusion Plating System (K141735) of ARTHREX ●
Arthrex Minimally Invasive Ankle Fusion Plate (K190953) of ARTHREX ●

4. Description of the device:	The Activ Fuse range consists of plates and screws designed for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. The system includes a modular plate design for a lateral calcaneal extension.
	The Activ Fuse range will be provided non-sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization.
Materials:	Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).
Function:	The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

5. Substantial equivalence claimed to predicate devices:

The Activ Fuse range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

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6. Indications for Use:

The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

7. Summary of the technological characteristics compared to predicate

The Activ Fuse range's intended use and indications for use are similar to the predicate devices

Material

The Activ Fuse range uses the same material as the predicate devices.

Design

The Activ Fuse range and the predicates differ slightly in their geometry, but are equivalent in terms of material and operating principles. The Activ Fuse plate has a modular plate design for a lateral calcaneal extension that the predicate devices do not have.

Sizes

The Activ Fuse range and the predicates are equivalent in their dimensions.

8. Non-clinical Test Summary:

The following tests were conducted:

. Engineering analysis and comparative static and dynamic tests were performed on the subject and predicate plates.
. Engineering analysis and static and dynamic tests were performed on the lateral extension for the calcaneus.
. Engineering analysis were performed on the screws regarding torsional and pullout strength
Endotoxin testing is performed using LAL quantitative kinetic chromogenic . method.

The analysis showed that the Activ Fuse range is as safe and as effective as the predicates.

9. Clinical Test Summary:

No clinical studies were performed.

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10. Conclusions Non-clinical and clinical:

Based on the indications for use, technological characteristics, and the summary of data submitted, Newclip Technics determined that the Activ Fuse range is equivalent to the predicate devices listed above.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.