The TiLock Cortical Spinal 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 spine: degenerative disc disease (DDD) (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); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine TiLock Pedicle Screw System (K100757). The subject devices differ from the predicate due to the addition of a thread on the distal portion of the screw shank.

This submission presents various device configurations based on surgical approach and patient anatomy, and consists of a Genesys Spine TiLock Cortical Spinal System, which may be implanted via a conventional (open) or over-the-wire procedures.

The Genesys Spine TiLock Cortical Spinal System is comprised of polyaxial screws (solid and cannulated) in various lengths and diameters, lock screws, and rods in various lengths. The TiLock Cortical cannulated polyaxial screws may be implanted via a conventional (open) technique or with an over-the-wire technique. Manual instrumentation for implantation of the system is available for both techniques. The overthe-wire procedure is performed using k-wires and fluoroscopy. The implantable components are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537.

AI/ML Overview

This document is a 510(k) premarket notification for the Genesys Spine TiLock Cortical Spinal System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices.

The key points from the document regarding the device and its equivalence are:

Device Name: Genesys Spine TiLock Cortical Spinal System
Regulation Number/Name: 21 CFR 888.3070 – Pedicle screw spinal system
Regulatory Class: Class III
Indications for Use: To provide immobilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities in skeletally mature patients (including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion).
Predicate Devices: TiLock Pedicle Screw System (K100757) and TiLock² Spinal System (K103671 / K152039).
Device Difference: The subject device differs from the predicates due to the addition of a thread on the distal portion of the screw shank.
Performance Data: The document explicitly states "Not Required. Detailed FEA analysis show that a new worst-case device was not created." This indicates that no new clinical or performance studies were deemed necessary by the submitter to demonstrate substantial equivalence, relying instead on Finite Element Analysis (FEA) to show that the modification did not create a new worst-case scenario compared to the cleared predicate devices.

Given this, I cannot provide the requested table and study details because the document itself states "Performance Data: Not Required" and relies on FEA rather than empirical testing with acceptance criteria.

To elaborate on why the specific questions cannot be answered from this document:

A table of acceptance criteria and the reported device performance: Not provided. The submission states performance data is not required due to FEA analysis.
Sample sized used for the test set and the data provenance: Not applicable. No test set data from human subjects or physical device testing is presented. The FEA analysis does not involve a "test set" in this context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
Adjudication method: Not applicable. No adjudication method for a test set is mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable. No empirical ground truth data is presented.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for the Genesys Spine TiLock Cortical Spinal System relies on a demonstration of substantial equivalence to predicate devices, supported by Finite Element Analysis (FEA) to address the minor design modification (addition of a thread). It does not include information on specific acceptance criteria and performance studies in the way one might expect for a novel device or an AI/ML product.

Summary

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

August 9, 2016

Genesys Spine Mr. William W. Sowers VP of Quality and Regulatory 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746

Re: K161914

Trade/Device Name: Genesys Spine TiLock Cortical Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: July 11, 2016 Received: July 12, 2016

Dear Mr. Sowers:

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" (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.

Vincent J. Devlin -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161914

Device Name

Genesys Spine TiLock Cortical Spinal 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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4. 510(K) SUMMARY

	Primary	Secondary
Submitter's Name:	Genesys Spine	Genesys Spine
Submitter's Address:	1250 Capital of TexasHighway SouthBuilding Three, Suite 600Austin, Texas 78746	1250 Capital of TexasHighway SouthBuilding Three, Suite 600Austin, Texas 78746
Submitter's Telephone:	512-381-7080	512-381-7071
Submitter's Fax:	800-817-4938	800-817-4938
Contact Name:	William W. Sowers	Brian J. Bergeron
Date Summary wasPrepared:	July 11, 2016
Trade or Proprietary Name:	Genesys Spine TiLock Cortical Spinal System
Common or Usual Name:	Spinal Fixation System
Classification Name:	Pedicle screw spinal system
Classification:	Class III
Regulation Number:	21 CFR 888.3070 – Pedicle screw spinal system
Product Codes:	NKB, MNH, MNI
Classification Panel:	Orthopedic Devices Panel
Legally Marketed(unmodified) devices toWhich SubstantialEquivalence is Claimed:	Primary Predicate:TiLock Pedicle Screw System (Genesys Spine -K100757)Additional Predicate(s):TiLock² Spinal System (Genesys Spine - K103671 /K152039)

Description Of The Device Subject To Premarket Notification:

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INDICATIONS FOR USE

The TiLock Cortical Spinal System is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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 failed previous fusion.

TECHNICAL CHARACTERISTICS

PERFORMANCE DATA

Not Required. Detailed FEA analysis show that a new worst-case device was not created.

CONCLUSION

The overall technology characteristics and FEA analysis data lead to the conclusion that Genesys Spine TiLock Cortical Spinal System is substantially equivalent to the Genesys Spine TiLock / TiLock2 Systems (Genesys Spine - K100757 / K103671 / K152039).

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.