The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.

The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach.

When used as a standalone system, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX® ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw.

When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

Device Description

The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. The system is comprised of interbodies, plates, and screws. The interbody device can be used as a standalone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4 V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V).

The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate.

The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (CYLOX® ST) and does not contain information about an AI/ML powered device, nor does it include a study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because these elements are specific to the evaluation of AI/ML devices, which is not the subject of this document.

The document describes the non-clinical performance testing conducted for the CYLOX® ST intervertebral body fusion device to demonstrate substantial equivalence to a predicate device. This testing focused on mechanical properties and structural integrity according to ASTM standards.

Here's the relevant information that could be extracted and how it relates to the request (even though it's not AI/ML related):

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Testing Standard)	Reported Device Performance
Static Axial Compression (ASTM F2077-22)	Verified (met standard requirements)
Static Axial Compression Shear (ASTM F2077-22)	Verified (met standard requirements)
Static Axial Torsion (ASTM F2077-22)	Verified (met standard requirements)
Dynamic Axial Compression (ASTM F2077-22)	Verified (met standard requirements)
Dynamic Axial Compression Shear (ASTM F2077-22)	Verified (met standard requirements)
Dynamic Axial Torsion (ASTM F2077-22)	Verified (met standard requirements)
Static Expulsion (ASTM F-04.25.02.02)	Verified (met standard requirements)
Static Subsidence (ASTM F2267-22)	Verified (met standard requirements)

Notes on the above table: The text states, "Substantial equivalence was supported by the results of verification testing to confirm that features, geometry and performance of the subject device performs as well as the predicate system, including: [list of tests]." This implies that the acceptance criteria were the successful completion and meeting of the requirements stipulated by each listed ASTM standard. The reported performance is that the device met these standards, thus demonstrating "substantial equivalence."

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

Sample Size: Not specified in the provided text. The ASTM standards would define the required sample sizes for each test.
Data Provenance: Not applicable. These are non-clinical (mechanical) tests, not clinical data or patient data.

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 as this is not an AI/ML study involving expert ground truth.

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

Not applicable as this is not an AI/ML study involving human adjudication.

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 is a non-clinical evaluation of an interbody fusion device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm.

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

Not applicable. Ground truth for these non-clinical tests would be the physical measurements and observations of the device's behavior under controlled testing conditions, compared against the specified parameters of the ASTM standards.

8. The sample size for the training set:

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

Not applicable.

Summary

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February 11, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SIGNUS Medizintechnik GmbH % Emily Szabo Quality & Regulatory Engineer JALEX Medical, LLC 27865 Clemens Road. Suite 3 Westlake, Ohio 44145

Re: K243188

Trade/Device Name: CYLOX® ST Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: September 30, 2024 Received: December 19, 2024

Dear Emily Szabo:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely, Katherine D. Kavlock -S for Brent Showalter, Ph.D.

Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243188

Device Name

CYLOX® ST

Indications for Use (Describe)

When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

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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Image /page/4/Picture/1 description: The image is a logo for SIGNUS. The logo consists of a stylized letter "S" on the left and the word "SIGNUS" on the right. Below the word "SIGNUS" is the phrase "The Spine Sign" with a horizontal line above and below the phrase. The letter "S" is gray and red.

510(k) Summary

Applicant:	SIGNUS Medizintechnik GmbHIndustriestrasse 2D-63755 Alzenau, GERMANY
Date:	09/30/2024
Contact Person:	Emily Szabo, Ph.D.
Contact Telephone:	(216) 452-2658
Contact Fax:	(440) 933-7839
Device Trade Name:	CYLOX® ST
Common Name:	Intervertebral body fusion device;
Device Classification Name:	Intervertebral Fusion Device With Integrated Fixation, Cervical(21 CFR 888.3080)
Device Class:	II
Reviewing Panel:	Orthopedic
Product Code:	OVE, ODP
Primary Predicate Device:	K201646 - Shoreline® ACS (Anterior Cervical System)
Reference Device:	K241438 – SIGNUS TETRIS™ ST, TETRIS™ R ST
Device Description:

Indications for Use and Intended Use:

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Image /page/5/Picture/1 description: The image contains the logo for SIGNUS. The logo consists of a stylized letter "S" on the left, with the word "SIGNUS" in bold, black letters on the right. Below the word "SIGNUS" is the tagline "The Spine Sign" in a smaller font, with a horizontal line above it. The stylized "S" is composed of a gray oval shape with red triangles on either side.

When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

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Image /page/6/Picture/0 description: The image is a logo for "SIGNUS The Spine Sign". The logo features a stylized letter "S" in gray and red, with the word "SIGNUS" in bold, black letters to the right of the "S". Below "SIGNUS" are the words "The Spine Sign" in a smaller font, underlined with a thin red line.

Summary of Technological Characteristics:

The subject CYLOX® ST has the same intended use and indications for use as the predicate system. The technological characteristics of the subject system are similar to those of the information provided herein demonstrates that any differences do not impact safety or effectiveness.

Item	Subject Device	Primary Predicate	Equivalence
	SIGNUS CYLOX® ST	SeaSpine Shoreline®ACS(K201646)
ClassificationName	Intervertebral Fusion Device With Integrated Fixation, Cervical;Intervertebral Fusion Device With Bone Graft, Cervical	Intervertebral Fusion Device With Integrated Fixation, Cervical;Intervertebral Fusion Device With Bone Graft, Cervical	Substantiallyequivalent
Regulation	21 CFR 888.3080(Intervertebral Body Fusion Device)	21 CFR 888.3080(Intervertebral Body Fusion Device)	Substantiallyequivalent
Product Code	OVE, ODP	OVE, ODP	Substantiallyequivalent
Indications forUse	The CYLOX® ST implants are interbody fusion devicesintended for anterior cervical interbody fusion procedures inskeletally mature patients with degenerative disc disease (DDD)of the cervical spine. DDD is defined as discogenic pain withdegeneration of the disc confirmed by history and radiographicstudies.The cervical device is to be used in patients who have had atleast six (6) weeks of non-operative treatment. The devices areto be used with autograft bone graft composed of cancellous,cortical, and / or corticocancellous bone and implanted via ananterior approach.When used as a standalone system, CYLOX® ST is intended tobe used as an adjunct to spinal fusion procedures at one level(C3-T1) and must be used with the CYLOX® ST bone screwfixation or connecting plate and must be secured with thecorresponding locking screw.When used with supplemental fixation, such as anterior cervicalplates, CYLOX® ST is intended to be used as an adjunct to	The Shoreline ACS (Anterior Cervical System) are interbodyfusion devices intended for anterior cervical interbodyfusion procedures in skeletally mature patients with degenerativedisc disease (DDD) of the cervical spine. DDD is defined asdiscogenic pain with degeneration of the disc confirmed byhistory and radiographic studies. The Shoreline ACS implantsare to be used with autograft bone graft and/or allogeneic bonegraft composed of cancellous, cortical, and / or corticocancellousbone and implanted via an anterior approach. The device is to beused in patients who have had atleast six (6) weeks of non-operative treatment.When used as a standalone system, Shoreline ACS is intended tobe used as an adjunct to spinal fusion procedures at one level(C2-T1) and must be used with the Shoreline ACS bone screwfixation and locking cover.When used with supplemental fixation, such as anterior cervicalplates, the Shoreline Cervical low profile (TruProfile) Interbody	Substantiallyequivalent

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Image /page/7/Picture/0 description: The image is a logo for "SIGNUS The Spine Sign". The logo has a gray and red graphic on the left side and the text "SIGNUS" on the right side. Below the text is the phrase "The Spine Sign" with a line above and below it.

Item	Subject Device	Primary Predicate	Equivalence
	SIGNUS CYLOX® ST	SeaSpine Shoreline®ACS(K201646)
	spinal fusion procedures at one or two levels of the cervicalspine (C3-T1).	Spacer is intended to be used as an adjunct to spinal fusionprocedures at one or two levels of the cervical spine (C2-T1).
Material	Cage: Ti-6Al-4V ELI per ASTM F3001Plate: Ti-6Al-4V ELI per ASTM F136Screws: Ti-6Al-4V ELI per ASTM F136	Cage: Polyetheretherketone (PEEK) per ASTM F2026,commercially pure titanium per ASTM F67Plate: Ti-6Al-4V ELI per ASTM F136Screws: Ti-6Al-4V ELI per ASTM F136	SubstantiallyEquivalent
Manufacturing	Cages: additive manufacturingPlates: traditional machiningScrews: traditional machining	Cages: Traditional molding and/or machiningPlates: Traditional molding and/or machiningScrews: Traditional molding and/or machining	SubstantiallyEquivalent
Sterilization	Sterile	Sterile	SubstantiallyEquivalent
ImplantationLevel	C3-T1	C2-T1	SubstantiallyEquivalent

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Image /page/8/Picture/1 description: The image is a logo for SIGNUS. The logo consists of a stylized letter "S" in red and gray, followed by the word "SIGNUS" in black, sans-serif font. Below the word "SIGNUS" is the tagline "The Spine Sign" in a smaller font, underlined with a thin red line.

Performance Testing - Non-Clinical:

Substantial equivalence was supported by the results of verification testing to confirm that features, geometry and performance of the subject device performs as well as the predicate system, including:

Static Axial Compression per ASTM F2077-22 .
Static Axial Compression Shear per ASTM F2077-22
. Static Axial Torsion per ASTM F2077-22
. Dynamic Axial Compression per ASTM F2077-22
. Dynamic Axial Compression Shear per ASTM F2077-22
. Dynamic Axial Torsion per ASTM F2077-22
. Static Expulsion per ASTM F-04.25.02.02
. Static Subsidence per ASTM F2267-22

Performance Testing - Clinical:

Clinical testing was not applicable to support a substantial equivalence determination for the subject device.

Conclusion

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.