The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Device Description

The Spineology Threshold Pedicular Fixation System consists of cannulated screws (titanium allov), curved and straight rods (titanium alloy), and adjustable Connector (titanium alloy), and fixed Connex Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold cannulated screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The cannulated screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems which are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Spineology Threshold™ Pedicular Fixation System. It focuses on demonstrating that new components (ConneX™ Cross Connector, ConneX™ Rod Connector, and 5.5 titanium Straight Rod devices) are substantially equivalent to previously cleared predicate devices. Therefore, the information provided primarily concerns non-clinical testing to support this substantial equivalence, rather than a clinical study evaluating the device's diagnostic performance for a specific condition.

Based on the provided text, here's a breakdown regarding acceptance criteria, study details, and related information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic device, nor does it report "device performance" in similar terms. Instead, the "acceptance criteria" are implied by the performance standards outlined in ASTM F1717, ASTM F1798, and ASTM F2193 for mechanical testing, and ANSI/AAMI ST-72:2011 for bacterial endotoxin testing. The "reported device performance" is a statement that the devices were tested in accordance with these standards.

Acceptance Criteria (Implied Standard)	Reported Device Performance (Compliance Statement)
Mechanical performance as defined by ASTM F1717 (Static Cantilever Bending)	Testing conducted in accordance with FDA Guidance: Spinal System 510(k)s (2004) and ASTM F1717-15.
Mechanical performance as defined by ASTM F1798 (Static Compression Bending)	Testing conducted in accordance with FDA Guidance: Spinal System 510(k)s (2004) and ASTM F1798.
Mechanical performance as defined by ASTM F2193 (Flexural Grip, Dynamic Compression Bending)	Testing conducted in accordance with FDA Guidance: Spinal System 510(k)s (2004) and ASTM F2193. (Specific tests mentioned: Flexural Grip, Dynamic Compression Bending).
Bacterial endotoxin limits as defined by ANSI/AAMI ST-72:2011	Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Note: The document states that these tests were performed and implies successful completion to demonstrate substantial equivalence, but it does not provide the raw data or specific quantitative results of these tests, which would typically be included in a full submission rather than this summary letter.

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

Test Set Sample Size: The document does not specify a "sample size" in terms of individual patients or cases for diagnostic accuracy. Instead, it refers to "representative worst case" devices for mechanical testing. The number of devices tested for each mechanical or bacterial endotoxin test is not disclosed.
Data Provenance: The data is from non-clinical (laboratory) testing, not from human subjects. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.

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

This section is not applicable as the document describes non-clinical mechanical and biological (endotoxin) testing of manufacturing components, not a clinical study requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical mechanical and biological (endotoxin) testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not reported in this document. This type of study is typically conducted for diagnostic or AI-assisted devices to evaluate human performance with and without AI. This submission is for surgical implants, and the testing focuses on the mechanical and biological safety of the components.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not reported. This device is not an algorithm or AI system, but rather physical implant components.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" (or reference standard) is the published performance specifications and methodologies within the cited ASTM standards. For bacterial endotoxin testing, the ground truth is the validated limits and methodologies within ANSI/AAMI ST-72:2011.

8. The Sample Size for the Training Set

This section is not applicable. This document describes the clearance of physical medical device components (implants), not an AI/ML algorithm that would have a training set.

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

This section is not applicable as there is no training set for an AI/ML algorithm.

Summary

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April 14, 2017

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Spineology Inc. Ms. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street North. Suite 600 Saint Paul, Minnesota 55128

Re: K170251

Trade/Device Name: Threshold™ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 26, 2017 Received: January 27, 2017

Dear Ms. Hauge:

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 of medical device-

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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 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) K170251

Device Name Threshold™ Pedicular Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "Spineology" in a bold, sans-serif font. To the right of the word is a graphic of a cluster of dots arranged in a circular pattern. The dots are a shade of purple, and the word "Spineology" is in black.

Date Prepared:	April 11, 2017
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: ihauge@spineology.com

Device Name and Classification

Trade Name:	Threshold™ Pedicular Fixation System
Common Name:	Thoracolumbosacral Pedicle Screw System
Classification Name:	Orthosis, Spinal Pedicle Fixation
Product Codes:	NKB
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3070
Panel:	Orthopedic

Predicate Devices

Primary:	K161694	Threshold™ Pedicular Fixation Systems (Spineology Inc.)
Additional:	K143403	Threshold™ Pedicular Fixation System (Spineology Inc.)
	K160980	Threshold™ and Palisade™ Pedicular Fixation Systems (Spineology Inc.)
	K123352	S4™ Spinal System (Aesculap Implant Systems, Inc.)
	K152968	Arsenal™ Spinal Fixation System (Alphatec Spine, Inc.)
	K120838	Synthes Matrix™ System (Synthes Spine)

I. Purpose

The purpose of this submission is to obtain FDA clearance for the addition of Spineology's ConneX™ Cross Connector, ConneX™ Rod Connector, and 5.5 titanium Straight Rod devices to its Threshold™ Pedicular Fixation System.

Device Name	510(k) #	Purpose of 510(k)
Threshold™ Pedicular Fixation System	K143403	Initial FDA Clearance
	K160980	Addition of Hydroxyapatite (HA) coated pedicle screws
	K161694	Addition of solid core pedicle screws

II. Regulatory History

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III. Device Description

Threshold™ System A.

B. ConneX™ Cross Connectors

ﻥ ConneX™ Rod Connectors

IV. Indications for Use

The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

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V. Comparison to Predicate

When compared to the predicate devices, the Connex Cross Connex Rod Connector, and Straight Rod devices have the same:

Intended Use
. Indications for Use
Fundamental Scientific Technology ●

VI. Non-Clinical Testing

A. ConneX™ Cross Connectors and ConneX™ Rod Connectors

The following mechanical testing was conducted on representative worst case ConneX Cross Connector and Connex Rod Connector devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards:

ASTM F1717

ASTM F1798

• Flexural Grip

ASTM F2193
Static Cantilever Bending
Static Compression Bending • Dynamic Compression Bending
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

B. Straight Rods

The following mechanical testing was conducted on representative Straight Rod devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards:

ASTM F1717-15

Static Compression Bending ●
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

VII. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the ConneX Cross Connector, Connex Rod Connector, and Straight Rod devices have been shown to be substantially equivalent to the legally marketed predicate devices.

Principle of Operation
. Materials of Construction

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.