The DYNAMIS™ SI Screw System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design. To accommodate varying patient anatomy, the DYNAMIS™ SI Screw Implants are available in multiple diameters and length offerings. The DYNAMIS™ SI Screw Implants consist of a cannulated central threaded body. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ SI Screw implants are single use devices that are provided sterile.

AI/ML Overview

This FDA 510(k) summary for the DYNAMIS™ SI Screw System does not describe an AI/ML device or a study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, and MRMC studies is not applicable.

The document primarily focuses on establishing substantial equivalence for a physical medical device (a sacrioiliac joint screw system) through mechanical performance testing against established ASTM standards and comparison to predicate devices.

However, I can extract the following relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Study Type)	Reported Device Performance
Static Cantilever Bending (per ASTM F3574)	"demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices."
Dynamic Cantilever Bending (per ASTM F3574)	"demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices."
Static Axial Pullout (per ASTM F543)	"demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices."
Static Torsion (per ASTM F543)	"demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices."
Driving Torque (per ASTM F543)	"demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices."

Note: The document states the device "demonstrate[s] that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices" for all tests, implying its performance met or exceeded the performance of the predicate devices based on these mechanical tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

The following numbered points are not applicable or cannot be extracted from the provided text as the document pertains to a physical medical device clearance, not an AI/ML software device performance study:

Sample sizes used for the test set and the data provenance: Not applicable. This is not a study assessing AI/ML model performance on a dataset of patient data. The "test set" refers to the physical screws undergoing mechanical testing. While not specified, these would be a sample of the manufactured screws.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert labels on medical images) is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing mechanical test results against established ASTM standards.
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 document is not about an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical AI/ML ground truth. For this device, the "ground truth" for performance is defined by the objective mechanical testing standards (ASTM F3574, ASTM F543) and comparison to the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device that requires a training set or associated ground truth.

Summary

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February 28, 2025

Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Promethean Restorative LLC Glenn Bowman President and CEO 333 Perry Street, Suite 210 Castle Rock, Colorado 80104

Re: K243565

Trade/Device Name: DYNAMIS™ SI Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: January 29, 2025 Received: January 29, 2025

Dear Glenn Bowman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Maziar Shah Mohammadi Digitally signed by Maziar Shah Mohammadi Date: 2025.02.28 10:26:28 -05'00'

For: Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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

Submission Number (if known)

K243565

Device Name

DYNAMIS™ SI Screw System

Indications for Use (Describe)

The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.

· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients

undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic 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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K243565 Page 1 of 2

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Company:	Promethean Restorative LLC333 Perry Street, Suite 210Castle Rock, CO 80104
Contact:	Glenn BowmanPromethean Restorative LLC333 Perry Street, Suite 210Castle Rock, CO 80104Phone: 303-330-8773regulatory@prometheanrestorative.com
Date Prepared:	February 26, 2025
Device Trade Name:	DYNAMIS™ SI Screw System
Common Name:	Sacroiliac Joint Fixation
Classification:	21 CFR §888.3040
Classification Name:	Smooth or threaded metallic bone fixation fastener
Class:	II
Product Code:	OUR, HWC
Primary Predicate:	SI-BONE iFuse TORQ® Implant System (K241574)
Additional Predicates:	Curiteva, Sacroiliac Joint Fusion System (K210402)Genesys Spine Sacroiliac Joint Fusion System (K191748)

Device Description:

Indications For Use:

The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for:

Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.
Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients ● undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

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Image /page/5/Picture/1 description: The image is a black and white logo. The logo consists of the letters 'P' and 'R' stacked on top of each other, with a flame-like design behind them. The letters and flame are enclosed within two concentric circles, creating a circular border around the design.

Substantial Equivalence:

The DYNAMIS™ SI Screw System has been demonstrated to be substantially equivalent with respect to indications, design, materials, function, manufacturing, and performance as compared to the predicate devices.

Performance Data:

Testing on the DYNAMIS™ SI Screw System included static cantilever bending and dynamic cantilever bending per ASTM F3574, as well as static axial pullout, static torsion, and driving torque per ASTM F543. The results demonstrate that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices.

Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject DYNAMIS™ SI Screw System has been shown to be substantially equivalent to legally marketed predicate devices.

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.