K Number

Device Name

Manufacturer

Reliance Medical Systems, LLC

Date Cleared

2012-01-20

(296 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

Predicate For

K123521,K152131,K162066,K213750

Intended Use

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 spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft 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, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis), 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, 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 and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; 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 poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, 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 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. (See Precautions section.) 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 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 document is a 510(k) summary for the Reliance Spinal Screw System, a spinal fixation device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through clinical studies in the same way an AI/software device would.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a test set, expert involvement, or details about training sets, as these are typically applicable to performance-based evaluations for AI/ML or diagnostic devices.

Here's why the requested information isn't available in this document:

Device Type: The Reliance Spinal Screw System is a physical medical device (spinal implant), not a software or AI-driven diagnostic tool. Its evaluation relies on mechanical testing and comparison to existing, legally marketed similar devices, not on diagnostic accuracy metrics.
510(k) Pathway: The 510(k) premarket notification pathway aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, technological characteristics (materials, design), and performance data (often non-clinical, such as mechanical testing). It does not usually require clinical studies to prove performance against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
Non-Clinical Testing: The document mentions "Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717." These are mechanical strength tests, common for implants, to ensure they can withstand physiological loads. The acceptance criteria for these tests would be defined by the ASTM standard, but the document does not elaborate on specific values or results.

Summary of requested information as found/not found in the document:

A table of acceptance criteria and the reported device performance: Not found. The document describes non-clinical mechanical testing (Static Compressive, Static Torsion, Dynamic Compressive per ASTM F1717) but does not provide specific acceptance criteria or performance values from these tests. These mechanical tests are to demonstrate structural integrity, not diagnostic performance.
Sample size used for the test set and the data provenance: Not applicable/Not found. As this is a mechanical device, performance is evaluated through non-clinical mechanical testing, not a "test set" of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found. Ground truth based on expert consensus is relevant for diagnostic or AI devices, not for a spinal screw system whose performance is assessed mechanically.
Adjudication method: Not applicable/Not found.
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/Not found. This is for AI-assisted diagnostic devices.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not found. This is for AI-driven algorithms.
The type of ground truth used: Not applicable/Not found.
The sample size for the training set: Not applicable/Not found. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable/Not found.

In conclusion, the document provides information relevant to the regulatory approval of a spinal implant device, focusing on its materials, design, intended use, and substantial equivalence to predicate devices, supported by non-clinical mechanical testing. It does not address the types of performance criteria or study designs typically associated with AI or diagnostic imaging devices.

Summary

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

110896

JAN 2 0 2012

510(k) Summary

Date Prepared: 29 March 2011

Bret M. Berry 545 South 500 West Suite 100 Bountiful, UT 84010 801-388-0700 Telephone: 801-294-0079 Fax:

Contact: Bret M. Berry Member-Manager

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

Product Code:

Substantial Equivalence

The Reliance Spinal Screw is substantially equivalent to the legally marketed Reliance Spinal Screw (K081978, K101112), Medronic TSRH Spinal System (K880215, K072429), Medtronic CD Horizon (K961633, K063670), DePuy Expedium Spine System (K041119, K081252), DePuy Isola Spinal System (K905184, K022285), DePuy Viper Spine System (K061520, K073562), DePuy MOSS Miami Spinal System (K933881, K030383), Pioneer Surgical Quantum Spinal System (K070973, K080518), K2M Range Spinal System (K080792), K2M Denali Spinal System (K042635, K052404), K2M Mesa Spinal System (K052398), Interpore Cross Synergy Spinal System (K940631, K041449), Stryker Xia Spinal System (K984251, K080928), X-Spine Capless Pedicle Screw System (K052847, K072282), Synthes Pangea (K052123). 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

い Intended Use/Indications for Use

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

K 110896

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).

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.

Technological Modifications

The subject RELIANCE Spinal Screw offers dual rod-to-rod connectors, end-to-end rod connectors, and offset connectors. Additionally, the subject RELIANCE Spinal Screw System offers extended tab MIS screws.

Page 2 of 2

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight.

Public Health Service

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

JAN 20 2012

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

Re: K110896

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: December 21, 2011 · Received: December 23, 2011

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

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

Page 2 - Mr. Bret M. Berry

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 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 go to for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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.

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

Sincerely yours,

Eind Keith

for Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): JE (CS2 Q

Device Name: Reliance Spinal Screw System

Indications for Use:

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, spinal tumor, and failed neerous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft 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 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, 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 and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K110896

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.