The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include:

Fractures and Osteotomies

· Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
· Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
· Talar fractures
· Ankle fractures
Navicular fractures
· Fractures of the fibula, malleolus, and calcaneus
· Metatarsal and phalangeal osteotomies
· Weil osteotomy
· Calcaneal osteotomy

Hallux Valgus Correction

· Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
Interphalangeal (IP) arthrodesis
· Proximal, midshaft, or distal osteotomy
Lapidus arthrodesis

Arthrodesis/Deformity Correction

1st MTP arthrodesis
Metatarsal deformity correction
· Tarsometatarsal joint arthrodesis
· Naviculocuneiform joint arthrodesis
· Talonavicular arthrodesis
Subtalar joint arthrodesis
· Triple arthrodesis
Medial column arthrodesis
Subtalar joint distraction arthrodesis
· Ankle arthrodesis
· Lateralizing calcaneal osteotomy
Lateral column lengthening
· Hammertoe

Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:

Medial and lateral column
· Subtalar, talonavicular, and calcaneocuboid

Device Description

The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including: fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sizedmatched washers are also available.

AI/ML Overview

The provided document is a 510(k) summary for the Paragon 28 Monster® Screw System. This document DOES NOT contain information regarding acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML device performance.

Instead, it's a regulatory submission for a medical device (bone fixation screws) demonstrating substantial equivalence to previously marketed predicate devices. The "studies" mentioned are preclinical tests (engineering analysis, torsional, pullout, insertion/removal evaluations, sterilization validations) to show that modifications to the screws do not adversely affect performance compared to the predicate devices.

Therefore, I cannot fulfill your request as the information requested is not present in the provided text.

Here's a breakdown of why this document doesn't fit your request:

Acceptance Criteria for AI/ML Performance: Not applicable. This is a traditional medical device (hardware).
Study Proving Device Meets Acceptance Criteria (AI/ML): Not applicable. The "studies" are mechanical and material tests for screws, not AI/ML performance evaluations.
Table of Acceptance Criteria and Reported Device Performance: Not applicable for AI/ML.
Sample Size for Test Set and Data Provenance: Not applicable for AI/ML.
Number of Experts for Ground Truth and Qualifications: Not applicable for AI/ML.
Adjudication Method: Not applicable for AI/ML.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. There are no human readers or AI assistance.
Standalone (algorithm only) Performance: Not applicable.
Type of Ground Truth Used: Not applicable for AI/ML. (For the screws, the "ground truth" would be the established mechanical properties and safety profiles of predicate devices).
Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable. This device does not use a training set in the AI/ML sense.

Summary

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April 3, 2019

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 the FDA logo, which 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. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E. STE 280 Englewood, Colorado 80112

Re: K190586

Trade/Device Name: Monster® Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 5, 2019 Received: March 6, 2019

Dear Eric Lintula:

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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190586

Device Name Monster® Screw System

Indications for Use (Describe)

Fractures and Osteotomies

· Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
· Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
· Talar fractures
· Ankle fractures
Navicular fractures
· Fractures of the fibula, malleolus, and calcaneus
· Metatarsal and phalangeal osteotomies
· Weil osteotomy
· Calcaneal osteotomy

Hallux Valgus Correction

· Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
Interphalangeal (IP) arthrodesis
· Proximal, midshaft, or distal osteotomy
Lapidus arthrodesis

Arthrodesis/Deformity Correction

1st MTP arthrodesis
Metatarsal deformity correction
· Tarsometatarsal joint arthrodesis
· Naviculocuneiform joint arthrodesis
· Talonavicular arthrodesis
Subtalar joint arthrodesis
· Triple arthrodesis
Medial column arthrodesis
Subtalar joint distraction arthrodesis
· Ankle arthrodesis
· Lateralizing calcaneal osteotomy
Lateral column lengthening
· Hammertoe

Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:

Medial and lateral column
· Subtalar, talonavicular, and calcaneocuboid

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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5. 510(K) SUMMARY

Device Trade Name:	Monster® Screw System
510(k) Number:	K190586
Manufacturer:	Paragon 28, Inc.4B Inverness Ct. E, Ste. 280Englewood, CO 80112
Contact:	Mr. Eric LintulaSenior Director of Quality and Regulatory AffairsPhone: 888-728-1888Email: elintula@paragon28.com
Prepared by:	Mr. Dave McGurlDirector, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NE, Suite 1000Washington, DC 20005Phone: 202.552.5800dmcgurl@mcra.com
Date Prepared:	March 5, 2019
Classification:	21 CFR 888.3040 Smooth or threaded metallic bone fixation
Class:	fastener.II
Product Code:	HWC; Screw, fixation, bone
Primary Predicate Device:	Paragon 28 Monster Screw System (K124027, K151418, K153378)
Additional Predicates:	Wright MICA Screw (K162353)Extremity Medical Axis Charcot Fixation System (K171018)Biomet Headless Compression and Twist-Off Screws (K142658)Extremity Medical Screw and Washer System (K101700)Acumed Cannulated Screw System (K123890)

Indications for Use:

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Paragon 28 Monster Screw System - Special 510(k)

Fractures and Osteotomies

Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) ●
Talar fractures
Ankle fractures ●
Navicular fractures
Fractures of the fibula, malleolus, and calcaneus ●
Metatarsal and phalangeal osteotomies ●
Weil osteotomy ●
Calcaneal osteotomy .

Hallux Valgus Correction

Fixation of osteotomies (i.e. Akin, Scarf, Chevron) ●
Interphalangeal (IP) arthrodesis ●
Proximal, midshaft, or distal osteotomy ●
Lapidus arthrodesis ●

Arthrodesis/Deformity Correction

1st MTP arthrodesis ●
Metatarsal deformity correction ●
Tarsometatarsal joint arthrodesis ●
Naviculocuneiform joint arthrodesis ●
Talonavicular arthrodesis ●
Subtalar joint arthrodesis ●
Triple arthrodesis
Medial column arthrodesis
Subtalar joint distraction arthrodesis ●
Ankle arthrodesis ●
Lateralizing calcaneal osteotomy ●
Lateral column lengthening
Hammertoe ●

Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:

Medial and lateral column ●
Subtalar, talonavicular, and calcaneocuboid ●

Device Description:

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Paragon 28 Monster Screw System - Special 510(k)

Substantial Equivalence of Indications for Use:

With respect to the primary predicate, the proposed Monster Screw System has the same indications. Specifically, both systems are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. The difference between the two systems is that the subject device lists specific examples of the indications. These specific examples are encapsulated in the indications of the primary predicate, and specifically identified in the indications of the additional predicates.

Substantial Equivalence of Technological Characteristics:

The subject Monster Screw System components possess the same technological characteristics as the predicate devices. These include:

. performance,
basic design,
material, manufacturing and ●
sizes (dimensions are comparable to those offered by the predicate systems). ●

Differences between the Monster Screw System implants and the predicate devices (i.e. modified head, thread and tip features, and additional components) were shown not to raise new questions of safety and effectiveness. Therefore, the Monster Screw System is substantially equivalent to the predicate devices with respect to indications, design, function, and performance.

Preclinical Testing:

Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. In addition, torsional, pullout, and insertion/removal evaluations were conducted for the modified components. Sterilization validations were also performed for the additional components. The results of the preclinical testing demonstrated the subject designs are substantially equivalent to the predicate devices.

Clinical Testing:

Clinical testing was not necessary to support equivalence.

Conclusion:

The Monster Screw System possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Monster Screw System is substantially equivalent for its 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.