The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6A14V per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, and connectors. The Dymaxeon Spine System can be used for single or multiple level fixations.

The purpose of this submission is to obtain clearance for a modification to the tulip and mating set screws.

AI/ML Overview

This document describes a 510(k) premarket notification for the Dymaxeon Spine System, focusing on a modification to the tulip and mating set screws. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Demonstrate equivalent performance to predicate device for thread change (axial grip testing per ASTM F1798).	"Engineering rationale and non-clinical tests were performed to evaluate the thread change (axial grip testing per ASTM F1798)." (Implies successful demonstration of equivalence, though specific numerical results are not provided in this summary.)

Note: The provided document is a 510(k) summary, which often provides high-level information. Specific quantitative acceptance criteria and detailed performance results for the axial grip testing (e.g., specific load values, displacement limits, or statistical equivalence margins) are not included in this summary. It only states that tests were performed to "evaluate the thread change" and that the device is "substantially equivalent."

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: This document does not specify the sample size for the "non-clinical tests" (axial grip testing). For mechanical testing, this would typically be a number of pedicle screws tested to failure.
- Data Provenance: The tests are stated as "non-clinical tests," implying laboratory bench testing. The country of origin for the data is not specified, but it would typically be conducted by or for the manufacturer (Back 2 Basics Direct, LLC) in a testing facility. It is prospective testing, as it's performed to evaluate a new modification prior to market.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable to this type of submission. The ground truth for mechanical testing of a medical device like a spine system is not established by human expert consensus or clinical outcomes. Instead, it is established by adherence to recognized national or international standards (e.g., ASTM F1798 for axial grip testing) and objective physical measurements and engineering principles. The "truth" is the physical performance of the device under defined conditions.
Adjudication Method for the Test Set:
- This question is not applicable. Mechanical tests are objective and quantitative. There is no need for human adjudication of results in the way there might be for clinical image interpretations. The "adjudication" is based on whether the measured values meet the specified engineering criteria or demonstrate equivalence to the predicate.
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. The Dymaxeon Spine System is a physical implant (pedicle screws, rods, hooks, connectors) for spine stabilization. It is not an AI-powered diagnostic or assistive technology that would involve human readers or image interpretation. Therefore, an MRMC study is irrelevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. As stated above, this is a physical implant, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing performed, the "ground truth" is the objective physical performance of the device components as measured against established engineering specifications and standards (e.g., ASTM F1798). The performance is compared to the known performance of the predicate device.
The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of mechanical performance testing of a physical medical implant. Training sets are relevant for machine learning algorithms.
How the ground truth for the training set was established:
- This question is not applicable for the same reasons as item 8.

In summary, the provided 510(k) summary focuses on demonstrating mechanical equivalence of a modified Dymaxeon Spine System to existing predicate devices through non-clinical laboratory testing. The criteria for demonstrating equivalence are based on established engineering standards (ASTM F1798). This type of submission does not involve clinical studies with human readers, AI algorithms, or "ground truth" established by expert consensus or pathology in the way that diagnostic devices might.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2017

Back 2 Basics Direct, LLC % Ms. Melissa Spang Quality/Regulatory Specialist JALEX Medical 30311 Clemens Road Suite #3D Westlake, Ohio 44145

Re: K170989

Trade/Device Name: Dymaxeon Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: April 21, 2017 Received: April 24, 2017

Dear Ms. Spang:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

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) K170989

Device Name Dymaxeon Spine System

Indications for Use (Describe)

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

Submitted by:	Back 2 Basics Direct, LLC6701 Rockside Road, Suite 200Independence, OH 44131
Date:	April 21, 2017
Contact Person:	Melissa Spang, Quality/Regulatory Specialist
Contact Telephone:	(440) 541-0060
Contact Fax:	(440) 933-7839
Device Trade Name:	Dymaxeon Spine System
Device Classification Name:	Thoracolumbosacral pedicle screw system
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Product Code:	NKB, KWP
Primary Predicate Device:	Dymaxeon Spine System (K150184)Additional predicate Dymaxeon Spine System (K121786)Additional predicate Stryker Spine Xia III Spinal System (K071373)There have been no recalls associated with these devices.

Device Description:

The purpose of this submission is to obtain clearance for a modification to the tulip and mating set screws.

Intended Use:

The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/leum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Mechanical Testing:

Engineering rationale and non-clinical tests were performed to evaluate the thread change (axial grip testing per ASTM F1798).

Substantial Equivalence:

The modified Dymaxeon Spine System has the same intended use, indications for use, principles of operation, and technological characteristics of the predicate. Modifications do not raise new questions of

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safety or effectiveness. Therefore, the modified Dymaxeon Spine System is substantially equivalent to the predicate.

Conclusion:

Back 2 Basics Direct, LLC concludes that the system is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.