The TiLock? 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 of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis: spinal tumor; and failed previous fusion (pseudarthrosis).

Device Description

The Genesys Spine TiLock2 Spinal System is offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.

AI/ML Overview

This document is a 510(k) premarket notification for a spinal system (TiLock2 Spinal System). The key takeaway is that this submission is for minor modifications to an already cleared device, rather than a completely new device. Therefore, it asserts substantial equivalence to its predicate devices without requiring new performance data for the implants themselves.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Implant Performance	The TiLock2 Spinal System implants must be substantially equivalent in performance and safety to previously cleared predicate devices. This implicitly means that their mechanical strength, biocompatibility, and intended function are maintained.	The TiLock2 Spinal System implants remain unchanged from their previously cleared configuration (K100757, K103034, and K152039). As such, it is stated that "no new testing or analysis is required." The document further asserts that "all of the implants have been previously cleared they do not present any new risks to mechanical strength or performance." The devices are "utilized in the same manner as the predicate devices."
Instrument Performance	System instrumentation, even with minor alterations, must function as intended and mimic previously cleared instruments without introducing new safety or effectiveness concerns.	The document states, "The instrument additions mimic previously cleared instruments with minor alterations." It concludes that "the added system instrumentation are all derivatives of previously cleared system devices and do not add any new technology or novel characteristics." Therefore, no new performance data was considered required.
Indications for Use	The TiLock2 Spinal System must be indicated for the same uses as its predicate devices, covering immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients for various spinal instabilities and deformities.	The Indications for Use for the TiLock2 Spinal System are identical to the predicate device in content (K152039), and cover immobilization and stabilization of spinal segments as an adjunct to fusion for: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). This demonstrates equivalence in intended use.
Material Composition	The implantable components must be manufactured from medical grade materials previously established as safe and effective for spinal implants (e.g., Ti-6Al-4V ELI titanium alloy and cobalt-chromium-molybdenum alloy).	The implantable components are manufactured from "medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537," which aligns with accepted materials for spinal implants and likely matches the predicate devices.
Technological Characteristics	The fundamental design and mechanisms of action of the system (e.g., polyaxial/monoaxial screws, rod connectors, etc.) must remain consistent with the predicate.	The "technology and characteristics of the TiLock2 Spinal System remains unchanged." It is composed of the same types of components (polyaxial/monoaxial screws, offset connectors, washers, etc.) as the predicate, and allows for the placement of 5.5mm titanium or cobalt chromium rods. The cannulated polyaxial screws may be implanted via a minimally invasive technique, which is a feature of the predicate.
New Risks	The modifications (adding a product code, clarifying classification, minor instrument revisions) must not introduce any new types of safety or effectiveness risks.	The submission specifically states that the implants "do not present any new risks to mechanical strength or performance." The added instrumentation "do not add any new technology or novel characteristics." This is the core argument for not requiring new performance data.

Study Details:

This submission is a Special 510(k), which means it relies on demonstrating substantial equivalence to previously cleared predicate devices for minor modifications, rather than presenting new comprehensive performance studies for the device itself. The "study" here is essentially the comparison and justification presented in the 510(k) submission.

No new performance data was required for this submission. The rationale is that the TiLock2 Spinal System implants remain unchanged from their previously cleared configuration (K100757, K103034, and K152039), and the instrument additions mimic previously cleared instruments with only minor alterations. Therefore, no new testing or analysis was deemed necessary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. As no new performance testing was conducted for this specific 510(k) submission (K171838), there is no "test set" of data in the traditional sense that would have a sample size or provenance. The determination of substantial equivalence relied on the previous clearance of the implant components and the assertion that new instruments were minor modifications.

3. 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 / Not provided. There was no new "test set" requiring ground truth establishment by experts for this submission. The regulatory body (FDA) reviews the substantial equivalence argument based on engineering principles, material science, and comparison to predicates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No specific test set with an adjudication method was conducted or referenced in this 510(k).

5. 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

No. This device is a mechanical spinal implant system, not an AI/imaging device. Therefore, MRMC studies and AI assistance are irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is a mechanical spinal implant system. This concept is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided directly for this submission. For the original predicate devices, the "ground truth" for their safety and effectiveness would have been established through a combination of:
- Mechanical testing: Demonstrating compliance with relevant ASTM standards for spinal implants (strength, fatigue, etc.).
- Material characterization: Verification of material specifications (ASTM F136, ASTM F1537) and biocompatibility.
- Preclinical studies (if applicable): Though not explicitly mentioned, some predicate devices might have undergone such studies.
- Clinical experience/literature: Supporting the general safety and effectiveness of similar devices and surgical approaches.
- FDA assessment: The FDA's review and clearance of the predicate devices (K100757, K103034, K152039, K122145) established their "ground truth" of substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a mechanical spinal implant system. The concept of a "training set" is generally used for machine learning or AI models, which is not relevant here.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

July 19, 2017

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

Re: K171838

Trade/Device Name: TiLock2 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: June 16, 2017 Received: June 20, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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) K171838

Device Name

TiLock2 Spinal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter's Name:	Genesys Spine
Submitter's Address:	1250 Capital of Texas Highway SouthBuilding Three, Suite 600Austin, Texas 78746
Submitter's Telephone:	512-381-7080
Submitter's Fax:	800-817-4938
Contact Name:	William W. Sowers
Date Summary wasPrepared:	June 16, 2017
Trade or Proprietary Name:	TiLock2 Spinal System
Common or Usual Name:	Spinal Fixation System
Classification Name:	Thoracolumbosacral Pedicle Screw System,Spinal Interlaminal Fixation Orthosis
Classification:	Class II
Regulation Number:	21 CFR 888.3070 – Thoracolumbosacral Pedicle ScrewSystem21 CFR 888.3050 – Spinal Interlaminal Fixation Orthosis
Product Codes:	NKB, KWP
Classification Panel:	Orthopedic Devices Panel
Legally Marketed(unmodified) devices toWhich SubstantialEquivalence is Claimed:	Primary Predicate:TiLock2 Spinal System (Genesys Spine - K152039)Additional Predicate(s):TiLock Pedicle Screw System (Genesys Spine - K100757 / K103671)LANX Spinal Fixation System (LANX - K122145)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The intent of this Special 510(k) is threefold:

1. To add the KWP product code to the system
1. Clarify the system classification is now Class II in accordance with Docket No. FDA-2014-N-1205
1. Add / revise system instrumentation

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INDICATIONS FOR USE

The TiLock 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 the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

TECHNICAL CHARACTERISTICS

The Genesys Spine TiLock- Spinal System is comprised of polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths. The TiLock System only allows the placement of 5.5mm titanium or cobalt chromium rods. The TiLock- cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the system is available for both conventional and minimally invasive procedures. The TiLock- tulips are available in three (3) configurations: standard, break off and extended tab. The extended tab tulips are only assembled utilizing cannulated screws, as it is intended to facilitate screw insertion during minimally invasive procedures. The TiLock implantable components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537.

The Genesys Spine TiLock2 Spinal System implants remain unchanged from their previously cleared configuration outlined in K100757, K103034, and K152039. As such no new testing or analysis is required. In addition, since all of the implants have been previously cleared they do not present any new risks to mechanical strength or performance. The devices in the TiLock' Spinal System are utilized in the same manner as the predicate devices.

PERFORMANCE DATA

Not Required. There was no change to the cleared system implants or the manner in which they are used. The instrument additions mimic previously cleared instruments with minor alterations.

CONCLUSION

The technology and characteristics of the TiLock2 Spinal System remains unchanged. Laminar hooks were previously cleared per K152039. This submission adds the KWP product code corresponding to spinal interlaminal fixation orthosis. The added system instrumentation are all derivatives of previously cleared system devices and do not add any new technology or novel characteristics. As a result, the modified TiLock Spinal System is considered substantially equivalent to the previous Genesys Spine TiLock / TiLock2 Systems (Genesys Spine - K100757 / K103671 / K152039) as well as the LANX Spinal Fixation System (K122145).

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.