Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
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™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

Device Description

The DYNAMIS™ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. The implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design and a cannulated central threaded body. To accommodate varying patient anatomy, the DYNAMIS™ Implants are available in multiple diameters and length offerings. 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™ implants are single use devices that are provided sterile. The DYNAMIS™ Implant System is comprised of DYNAMIS™ Screws and DYNAMIS™ TRU-NANO Screws.

DYNAMIS™ TRU-NANO Screws: The surfaces of the DYNAMIS™ TRU-NANO Screws incorporate a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the screws have been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These screws are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-97 nanometers. Calcium and phosphate are incorporated into the nanotube surface.

AI/ML Overview

This document describes the DYNAMIS™ Implant System, a medical device for sacroiliac joint fusion and pelvic fracture fixation. The FDA 510(k) clearance letter determines the device to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain acceptance criteria for device performance or a detailed study description proving that the device meets those criteria, as typically found in a clinical study report or a more comprehensive technical document.

Instead, the performance data section mentions:

Testing per ASTM standards:
- Static cantilever bending and dynamic cantilever bending (ASTM F3574)
- Static axial pullout, static torsion, and driving torque (ASTM F543)
In vitro evaluations for nanotechnology: Quantitated mineralization of extracellular matrix by osteoblasts (OB) and mesenchymal stem cells (MSC) on titanium alloy surfaces.
Bacterial endotoxin testing: In accordance with AAMI ST72:2011.

The statement reads: "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." and "in vitro study results demonstrated that the DYNAMIS™ TRU-NANO Screw nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces."

Without further information, I cannot provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The provided document is a regulatory clearance letter, which summarizes the basis for clearance, but does not include the detailed technical study reports.

Thus, I can only provide the information that is present in your input.

Based on the provided FDA 510(k) clearance letter (K251075) for the DYNAMIS™ Implant System, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria for the mechanical tests. Instead, it states that the performance testing results "demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." For the nanotechnology aspect, the acceptance criterion implicitly relates to superior mineralization.

Test Category	Specific Test (Standard)	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Testing	Static cantilever bending (ASTM F3574)	Performance comparable/equivalent to predicate devices.	"The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices."
	Dynamic cantilever bending (ASTM F3574)	Performance comparable/equivalent to predicate devices.	"The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices."
	Static axial pullout (ASTM F543)	Performance comparable/equivalent to predicate devices.	"The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices."
	Static torsion (ASTM F543)	Performance comparable/equivalent to predicate devices.	"The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices."
	Driving torque (ASTM F543)	Performance comparable/equivalent to predicate devices.	"The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices."
Biological Testing	Nanotechnology - Cell Mineralization (In vitro)	Statistically significantly greater mineralization.	"in vitro study results demonstrated that the DYNAMIS™ TRU-NANO Screw nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces." (compared to "other surfaces" - likely meaning unsuffaced titanium or the non-nano predicate)
Sterility Testing	Bacterial endotoxin testing (AAMI ST72:2011)	Meet specified testing limit.	"Bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes for any of the tests (mechanical, in vitro, or endotoxin).

Regarding data provenance:

The mechanical and biological testing appears to be laboratory-based performance testing on the device itself and its components.
The document implies the tests were conducted by the manufacturer or a contracted lab for regulatory submission.
There is no mention of patient data (e.g., country of origin, retrospective/prospective clinical data) as this device is not an AI/imaging device. The testing is for the physical device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or not provided in the context of the described device testing.

For mechanical tests, the "ground truth" is derived from engineering standards (ASTM) and predicate device performance. No human experts are typically involved in establishing "ground truth" for these tests in the way they would for medical image interpretation or clinical outcomes.
For in vitro biological tests, expert understanding of cell biology and statistical analysis is involved, but not in the sense of adjudicating a "ground truth" from a test set of patient cases.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as there is no human interpretation or consensus process described for the test results. The tests are laboratory-based and yield objective measurements compared against standards or predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation devices to assess human reader performance with and without AI. The DYNAMIS™ Implant System is a physical orthopedic implant, not a diagnostic or AI software.

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

This information is not applicable. The DYNAMIS™ Implant System is a physical medical implant, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims appears to be:

Engineering Standards: For mechanical tests, adherence to and performance relative to ASTM F3574 and ASTM F543 requirements.
Predicate Device Performance: Comparative performance against the DYNAMIS™ SI Screw System (K243565) and Nanovis Nano FortiFix (K193211) for mechanical properties.
Biological Activity (Quantitative Measurement): For the nanosurface, quantifiable measurements of secreted extracellular matrix mineralization by specific cell types (osteoblasts and mesenchymal stem cells) in an in vitro laboratory setting.
Regulatory Standards: For bacterial endotoxin testing, compliance with AAMI ST72:2011.

8. The Sample Size for the Training Set

This information is not applicable or not provided. "Training set" refers to data used to train machine learning models. This device is a physical implant, not an AI or software device that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As established above, there is no mention of an AI/ML component or a "training set" for this physical device.

Summary

FDA 510(k) Clearance Letter - DYNAMIS™ Implant System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 25, 2025

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

Re: K251075
Trade/Device Name: DYNAMIS™ Implant 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: April 4, 2025
Received: April 8, 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"

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K251075 - Glenn Bowman Page 2

(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).

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 QS 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K251075 - Glenn Bowman Page 3

Sincerely,

Maziar Shah Mohammadi

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

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K251075

Please provide the device trade name(s).

DYNAMIS™ Implant System

Please provide your Indications for Use below.

The DYNAMIS™ Implant System is indicated for sacroiliac joint fusion for:

Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
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™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Page 5

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 LLC
333 Perry Street, Suite 210
Castle Rock, CO 80104

Contact: Glenn Bowman
Promethean Restorative LLC
333 Perry Street, Suite 210
Castle Rock, CO 80104
Phone: 303-330-8773
regulatory@prometheanrestorative.com

Date Prepared: April 21, 2025

Device Trade Name: DYNAMIS™ Implant 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: DYNAMIS™ SI Screw System (K243565)
Reference Device: Nanovis Nano FortiFix (K193211)

Device Description:

DYNAMIS™ TRU-NANO Screws: The surfaces of the DYNAMIS™ TRU-NANO Screws incorporate a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the screws have been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These screws are electrochemically treated to possess a controlled nanotopography

K251075
Page 1 of 2

Page 6

composed of nanotube arrays having a pore size diameter between 30-97 nanometers. Calcium and phosphate are incorporated into the nanotube surface.

Indications For Use:

The DYNAMIS™ Implant System is indicated for sacroiliac joint fusion for:

Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
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™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

Substantial Equivalence:

The DYNAMIS™ Implant 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™ Implant 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™ Implant System is substantially equivalent to the predicate devices.

To address the "Points to Consider" in the FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, in vitro evaluations were relied upon which quantitated the mineralization of extracellular matrix secreted by osteoblasts (OB) and mesenchymal stem cells (MSC) on surfaces created from a titanium alloy substrate. The in vitro study results demonstrated that the DYNAMIS™ TRU-NANO Screw nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces.

Bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011 and met the specified testing limit.

Conclusion:

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

K251075
Page 2 of 2

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.