The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe degenerative spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: degenerative spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

Device Description

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly.

The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Spinal Screw System." This notification primarily focuses on establishing substantial equivalence to existing predicate devices based on material, intended use, size range, and strength. It also mentions non-clinical testing performed according to ASTM standards.

However, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in detail for AI/software-driven medical devices. The Reliance Spinal Screw System is a physical orthopedic implant, not an AI/software device, and thus the type of information requested (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable or present in this regulatory submission.

Specifically, the document lacks details on:

Acceptance criteria and reported device performance (in a table): The document states the device underwent "Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717," but it does not provide the specific acceptance criteria or the reported performance data from these tests.
Sample sizes for test set and data provenance: Not applicable in the context of an orthopedic implant device.
Number of experts and their qualifications for ground truth: Not applicable.
Adjudication method: Not applicable.
MRMC comparative effectiveness study and effect size: Not applicable as this is not an AI-assisted diagnostic device.
Standalone algorithm performance: Not applicable.
Type of ground truth used: Not applicable.
Training set sample size: Not applicable.
How ground truth for training set was established: Not applicable.

The core of this 510(k) submission is to demonstrate that the expanded Reliance Spinal Screw System (with new screw types and rods) is substantially equivalent to previously cleared versions and other predicate devices, primarily through comparison of its physical characteristics, materials, indications for use, and a statement of compliance with mechanical testing standards (ASTM F1717). The results of these mechanical tests are not detailed in this publicly available summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

September 17, 2015

Reliance Medical Systems, LLC Mr. Bret M. Berry Member-Manager 545 South 500 West, Suite 100 Bountiful. Utah 84010

Re: K152131

Trade/Device Name: Reliance Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWQ Dated: August 20, 2015 Received: August 24, 2015

Dear Mr. Berry:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

Page 2 - Mr. Bret M. Berry

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/Resourcesfor You/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 vours.

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152131

Device Name Reliance Spinal Screw System

Indications for Use (Describe)

The RELIANCE Spinal Screw System is a pedicle screw systems 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, soliosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation for the following indications: degenerative spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyhosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Bret M. Berry 545 South 500 West Suite 100 Bountiful, UT 84010 Telephone: 801-295-3280 Fax: 801-294-0079

Bret M. Berry Contact: Member-Manager

Date Prepared: August 24, 2015

Common or Usual Name:	Spinal Fixation Device
Proposed Proprietary or Trade Name:	Reliance Spinal Screw System
Classification Name:	Spondylolisthesis Spinal Fixation DeviceSystem and Pedicle Screw System (per 21CFR 888.3070)Spinal Intervertebral Body Fixation Orthosis(per 21 CFR 888.3060)Spinal Interlaminal Fixation Orthosis (per 21CFR 888.3050)
Product Code:	MNI, MNH, KWP, KWQ

Substantial Equivalence

The Reliance Spinal Screw system is substantially equivalent to the legally marketed Reliance Spinal Screw (K081978, K10112, K110896 and K123521), which is the primary predicate device, and the Nuvasive SpherX (K102514). The Reliance Spinal Screw is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and strength.

Device Description

{4}------------------------------------------------

with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

Technological Modifications

The subject RELIANCE Spinal Screw offers 2 new screws, Bicortical & Cancellous Screws. Cortical Screws, and MIS bullet-tipped rods. These new screws and rods will be available in similar sizes & configurations as the currently approved Reliance Pedicle Screws (K123521). The subject RELIANCE Spinal Screw System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.

Intended Use/Indications for Use

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: degenerative

spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

Non-Clinical Testing

The RELIANCE Spinal Screw System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717.

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.