The R3ACT™ Stabilization System is intended as an adjunct in fracture repair and ligamentous injuries of small bones of the feet and ankles including the distal tibia, distal fibula, talus, and calcaneus, and as an adjunct in external and intramedullary fixation systems involving plates and rods. Specifically, the R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Device Description

The R3ACT™ Stabilization System is a fixation device comprised of a titanium alloy screw, UHMWPE suture, and a polyurethane component. It is provided in various sizes to accommodate patient anatomy. The device maintains fixation prior to weight bearing and then allows motion after weight bearing. The implants can be used in conjunction with the Baby Gorilla®/Gorilla® Plating System (K203511).

AI/ML Overview

This document describes the R3ACT™ Stabilization System, a medical device for fracture repair and ligamentous injuries of the feet and ankles. It is a 510(k) premarket notification to the FDA. The information provided is for a conventional medical device, not an AI/ML powered medical device. Therefore, the questions related to AI/ML powered devices cannot be fully answered.

Here's the information extracted from the provided text regarding the device and its testing:

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

The provided text states: "All performance testing conducted for the R3ACTTM Stabilization System met the predetermined acceptance criteria or were otherwise considered acceptable." However, specific quantitative acceptance criteria and detailed performance results for each test are not provided in the document.

The document lists the following performance tests conducted:

Test Type	Reported Device Performance
Torque to failure	Met predetermined acceptance criteria
Insertion and removal torque	Met predetermined acceptance criteria
Static pullout	Met predetermined acceptance criteria
Static bending	Met predetermined acceptance criteria
Static axial dissociation	Met predetermined acceptance criteria
Dynamic axial dissociation	Met predetermined acceptance criteria
Bacterial endotoxin testing	Test results meet acceptance criteria

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes (number of devices/components) used for each performance test. It also does not discuss data provenance in terms of country of origin or retrospective/prospective as these are typically relevant for clinical studies, which were not performed for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device underwent performance testing (mechanical and material tests) on the device itself, not a clinical study involving human or image data with ground truth established by experts.

4. Adjudication method for the test set

This question is not applicable for the same reason as point 3. Performance tests on a physical device do not involve adjudication by experts.

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

This question is not applicable. This is a conventional medical device, not an AI/ML powered device. No MRMC study was performed, and thus no effect size related to AI assistance is provided.

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

This question is not applicable. This is a conventional medical device, not an AI/ML powered device. No algorithm-only performance was evaluated.

7. The type of ground truth used

For the performance testing mentioned (e.g., torque to failure, static pullout), the "ground truth" would be the engineered specifications and expected physical behavior of the device components under various loads, as defined by engineering standards and design requirements. It's not "expert concensus, pathology, or outcomes data" in the context of clinical evaluation.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML powered device and therefore does not have a "training set" in the machine learning sense. The testing performed was for product performance validation.

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

This question is not applicable, as there is no training set for this conventional medical device.

Summary

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December 25, 2021

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.

Paragon 28, Inc. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112

Re: K211770

Trade/Device Name: R3ACT™ Stabilization System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN, MBI Dated: June 4, 2021 Received: June 8, 2021

Dear Haylie Hertz:

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 and Part 809); 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,

for

Laura C. Rose, PhD 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)

K211770

Device Name R3ACT™ Stabilization System

Indications for Use (Describe)

The R3ACT™ Stabilization System is intended as an adjunct in fracture repair and ligamentous injuries of small bones of the feet and ankles including the distal tibia, distal fibula, talus, and as an adjunct in external and intramedullary fixation systems involving plates and rods. Specifically, the R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

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

510(k) Number:	K211770
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Haylie HertzSenior Regulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com
Date Prepared:	December 23, 2021
Device Trade Name:	R3ACT™ Stabilization System
Device Class andCommon Name:	Class II, Syndesmosis Repair Device
Classification:	Primary - 21 CFR 888.3040: Single/multiple componentmetallic bone fixation appliances and accessories.Secondary - 21 CFR 888.3030: Single/multiple componentmetallic bone fixation appliances and accessories.
Product Codes:	Primary - HWCSecondary - HTN, MBI
Indications for Use:	The R3ACT™ Stabilization System is intended as an adjunctin fracture repair and ligamentous injuries of small bones ofthe feet and ankles including the distal tibia, distal fibula,talus, and calcaneus, and as an adjunct in external andintramedullary fixation systems involving plates and rods.Specifically, the R3ACT™ Stabilization System is intendedto provide fixation during the healing process following asyndesmotic trauma, such as fixation of syndesmosis(syndesmosis disruptions) in connection with Weber B and Cankle fractures.
Device Description:	The R3ACT™ Stabilization System is a fixation devicecomprised of a titanium alloy screw, UHMWPE suture, anda polyurethane component. It is provided in various sizes to

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accommodate patient anatomy. The device maintains fixation prior to weight bearing and then allows motion after weight bearing. The implants can be used in conjunction with the Baby Gorilla®/Gorilla® Plating System (K203511). Predicate Device: FibuLink Syndesmosis Repair System (K173550) Additional Predicates: Baby Gorilla®/Gorilla® Plating System (K203511) TRIMit Screw System (K041189) ZipTight System (K130033) R3ACTTM Stabilization System is substantially The Substantial Equivalence: equivalent to the legally marketed predicate device with respect to intended use and design. The subject system shares the same materials (titanium and UHMWPE), features, and intended use. Differences in materials (polyurethane), design, sizing, and manufacturing were shown not to introduce new questions of safety and effectiveness. All necessary testing has been performed on representative Performance Testing: R3ACTTM Stabilization System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. The device performance was characterized via torque to failure, insertion and removal torque, static pullout, static bending, static axial dissociation, and dynamic axial dissociation testing.

Bacterial endotoxin testing was also conducted and the test results meet acceptance criteria.

Clinical data are not needed to support the safety and effectiveness of the subject device.

R3ACTTM Stabilization System subject to this Conclusions: The submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the R3ACTTM Stabilization System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the R3ACTTM Stabilization System components are substantially equivalent to the predicate device for the intended use.

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.