(200 days)
No
The summary describes a mechanical fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a "fixation device" intended to provide "fixation during the healing process" for fractures and ligamentous injuries, which suggests a supportive rather than a directly therapeutic role.
No
The R3ACT™ Stabilization System is described as a "fixation device" intended to provide stability during the healing process of fractures and ligamentous injuries. It is comprised of a screw, suture, and polyurethane component, and its function is to maintain fixation and allow motion after weight bearing. This indicates it is a therapeutic or assistive device, not one designed to diagnose medical conditions.
No
The device description explicitly states it is comprised of physical components (titanium alloy screw, UHMWPE suture, polyurethane component) and is a fixation device, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the R3ACT™ Stabilization System is a fixation device used in fracture repair and ligamentous injuries of bones in the feet and ankles. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant (screw, suture, polyurethane component) designed to provide mechanical support and fixation during the healing process. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The R3ACT™ Stabilization System does not fit this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
HWC, HTN, MBI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet and ankles including the distal tibia, distal fibula, talus, and calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K173550, K203511, K041189, K130033
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
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 Hertz |
| Senior Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | December 23, 2021 |
| Device Trade Name: | R3ACT™ Stabilization System |
| Device Class and | |
| Common Name: | Class II, Syndesmosis Repair Device |
| Classification: | Primary - 21 CFR 888.3040: Single/multiple component |
| metallic bone fixation appliances and accessories. | |
| Secondary - 21 CFR 888.3030: Single/multiple component | |
| metallic bone fixation appliances and accessories. | |
| Product Codes: | Primary - HWC |
| Secondary - HTN, MBI | |
| Indications for Use: | 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 |
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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.