The Threshold Pedicular Fixation System and Palisade Pedicular Fixation System are 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 radies), 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 titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. 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 Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. 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.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the Spineology Threshold Pedicular Fixation System and Palisade Pedicular Fixation System. It describes the devices and their intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to the device's function or clinical outcomes.

The purpose of this 510(k) submission is to obtain clearance for the addition of a hydroxyapatite (HA) coating to existing pedicle screws. The core argument for substantial equivalence is that the HA-coated screws are fundamentally the same as the predicate devices, with the coating being a minor change.

Here's a breakdown of the requested information based on the document, noting where information is absent:

Table of acceptance criteria and the reported device performance:
The document states: "Testing was not required to support this change. Spineology's risk analysis is sufficient to demonstrate the substantial equivalence of the HA-coated Threshold and Palisade pedicle screws to the predicate devices."
Therefore, there are no specific acceptance criteria or reported device performance metrics for the device's functional performance or clinical outcomes presented in this document. The submission relies on substantial equivalence to predicate devices, which means their performance characteristics are considered similar to devices already cleared for market.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
As no performance testing was required or reported, there is no test set sample size or data provenance mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no test set requiring ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set requiring adjudication is described.
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. The device is a pedicle fixation system, not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a pedicle fixation system, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no study requiring ground truth is described.
The sample size for the training set:
Not applicable, as this is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning device.

In summary, this 510(k) submission for the Spineology Threshold and Palisade Pedicular Fixation Systems (with HA coating) relies on the demonstration of substantial equivalence to legally marketed predicate devices, rather than on new performance testing to meet predefined acceptance criteria. The change is considered minor (addition of HA coating), and no new clinical or non-clinical performance studies were presented as part of this particular submission to prove specific performance metrics.

Summary

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

May 26, 2016

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

Re: K160980

Trade/Device Name: Threshold Pedicular Fixation System. Palisade Pedicular Fixation Svstem Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: April 5, 2016 Received: April 7, 2016

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

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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" (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 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 yours,

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)

K160980

Device Name Threshold Pedicular Fixation System Palisade Pedicular Fixation 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

Date Prepared:	April 05, 2016
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs MangerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com

Device Name and Classification

Trade Name:	Threshold Pedicular Fixation SystemPalisade Pedicular Fixation System
Common Name:	Pedicle Screw System
Classification Name:	Pedicle Screw Spinal System
Product Codes:	NKB,MNI, MNH
Regulatory Class:	MNI, MNH: Class II NKB: Class III
Regulation Number:	MNI, MNH: 888.3070(b)(1) NKB: 888.3070(b)(2)
Panel:	Orthopedic

Predicate Devices

Primary:	K152148	Fortress Pedicle Screw System
Additional:	K143403	Threshold Pedicular Fixation System
	K153323	Palisade Pedicular Fixation System

Purpose

Obtain 510(k) clearance for the addition of hydroxyapatite (HA) coating to Spineology's Threshold and Palisade pedicle screws.

Device Description - Threshold Pedicular Fixation System

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Device Description - Palisade Pedicular Fixation System

Intended Use / Indications for Use

The Threshold Pedicular Fixation System and Palisade Pedicular Fixation System are 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.

Technological Characteristics

When compared to the predicate devices, HA-coated Threshold and Palisade pedicle screws have the same:

Intended Use
Indications for Use ●
Fundamental Scientific Technology ●
Principle of Operation ●
. Biological Safety
Base Materials
Base Design
Size Offering ●
Hydroxyapatite Coating ●

Non-Clinical Testing

Testing was not required to support this change. Spineology's risk analysis is sufficient to demonstrate the substantial equivalence of the HA-coated Threshold and Palisade pedicle screws to the predicate devices.

Conclusion

Spineology has demonstrated that the HA-coated Threshold and Palisade pedicle screws are substantially equivalent to the predicate devices. The fundamental scientific principle, primary technological characteristics, and intended use are unchanged from 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.