The CONDUIT™ SYNFIX™ Evolution Secured Spacer System is a stand-alone anterior interbody fusion device with a microscope roughened surface and micro and nano-scale features indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the CONDUIT SYNFIX Evolution can be packed with autograft. If used with less than the four integrated bone screws, or for hyperlordotic implants (>20Deg), implants must be used with supplemental fixation systems cleared by the FDA for use in the lumbosacral spine.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Device Description

The CONDUIT SYNFIX Evolution Secured Spacers are intervertebral body fusion devices intended for lumbar interbody fusion (ALIF). Four Screws are inserted through the anteriorly-located Plate into the adjacent vertebral bodies. The Screws lock securely to the Plate using a tapered-thread locking mechanism.

The CONDUIT SYNFIX Evolution Secured Spacer System is available as non-assembled Cage and Plate components in various heights and geometries to suit individual pathology and anatomical conditions. The Cage and Plate components are intended to be assembled at the point of use prior to implantation.

The CONDUIT SYNFIX Evolution Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The 3D Printed Conduit Cellular Titanium Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the Cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

AI/ML Overview

The provided text is a 510(k) clearance letter for a medical device called the "CONDUIT™ SYNFIX™ Evolution Secured Spacer System," which is an intervertebral body fusion device.

Crucially, this document is for a traditional medical device (an implantable hardware system), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets for AI, expert adjudication of AI ground truth, MRMC studies for AI, or standalone AI performance, is not applicable to this submission.

The acceptance criteria and study proving the device meets them, as described in this 510(k), relate to the mechanical performance, material properties, and biocompatibility of the physical interbody fusion device, not an AI algorithm.

Here's an analysis of the provided information relevant to the device's acceptance criteria and studies:

Acceptance Criteria and Device Performance (for a physical medical device):

The document mentions that mechanical testing was performed to "allow comparison with established acceptance criteria." While the specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) are not explicitly detailed in the publicly available summary (which is common for 510(k) summaries), the types of tests conducted and the general conclusion indicate that the device met these criteria.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical Integrity	Performed per ASTM F2077-24 (Static and Dynamic Axial Compression, Compression Shear), ASTM F2267-24 (Subsidence), and Expulsion
MR Compatibility	Evaluated per ASTM F2052-21 (Magnetically Induced Displacement Force), ASTM F2213-17 (Magnetically Induced Torque), ASTM F2119-24 (MR Image Artifact), and ASTM F2182-19e2 (RF-induced Heating) to support MR Conditional labeling.
Biocompatibility	Implied to be equivalent to predicate devices, as materials are medical grade titanium (Ti-6Al-4V ELI, Ti-6Al-4V, Ti-6Al-7Nb) which are well-established for this application. Specific tests not detailed but generally required for implants.
Sterility	Implied to be equivalent to predicate devices. Specific tests not detailed but generally required.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the summary document. For mechanical testing of medical devices, "sample size" refers to the number of physical device units tested for each configuration or stress condition. These studies are typically conducted in a laboratory setting.
Data Provenance: Laboratory testing (mechanical, MR compatibility). The country of origin of the data is not specified but is typically internal lab data or contracted third-party lab data.
Retrospective or Prospective: Not applicable in the traditional sense for physical device testing. The tests are designed to assess the device's properties under simulated conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This pertains to AI/software performance evaluation. For physical device testing, "ground truth" is established by calibrated measuring equipment and standardized test methods (e.g., ASTM standards). The "experts" are typically engineers and technicians responsible for conducting the tests and interpreting the results against pre-defined engineering acceptance criteria.

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

Not Applicable. This relates to human expert consensus for AI ground truth labeling. For mechanical testing, the results are objective measurements from testing equipment validated against industry standards.

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:

Not Applicable. This is specific to AI/software for diagnostic or image-interpretation tasks. No such study was conducted or required for this physical device.

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

Not Applicable. This is specific to AI/software.

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

For mechanical testing, the "ground truth" is derived from standardized test methods (e.g., ASTM F2077, F2267) that define specific performance thresholds based on mechanical properties (e.g., ultimate strength, displacement within limits) and material science. The goal is to demonstrate that the device performs equivalently to predicate devices under defined mechanical loads and environmental conditions.

8. The sample size for the training set:

Not Applicable. This pertains to AI model development.

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

Not Applicable. This pertains to AI model development.

Conclusion from the 510(k) Summary:

The manufacturer "demonstrated substantial equivalence" by showing that their device performs mechanically and in terms of MR compatibility similarly to legally marketed predicate devices, and that the materials and design are appropriate for the intended use. The reliance on established ASTM standards and comparison to predicate devices are the primary methods for demonstrating safety and effectiveness for this type of medical implant.
The summary explicitly states: "No clinical data was necessary to demonstrate substantial equivalence, nor safety and effectiveness of this system." This further confirms that the evaluation was based on non-clinical (mechanical, material, and MR compatibility) testing and comparison to predicates.

Summary

FDA 510(k) Clearance Letter - CONDUIT™ SYNFIX™ Evolution Secured Spacer System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 10, 2025

Avalign Technologies, Inc.
Jennifer Staunton
Director Regulatory Affairs
8727 Clinton Park Drive
Fort Wayne, Indiana 46825

Re: K250072
Trade/Device Name: CONDUIT™ SYNFIX™ Evolution Secured Spacer System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX, OVD
Dated: June 11, 2025
Received: June 11, 2025

Dear Jennifer Staunton:

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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K250072 - Jennifer Staunton Page 2

(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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K250072 - Jennifer Staunton Page 3

Sincerely,

Brent Showalter -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250072

Device Name
CONDUIT™ SYNFIX™ Evolution Secured Spacer 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Submitter: Avalign Technologies, Inc.
8727 Clinton Park Drive
Fort Wayne, IN 46825 USA

Contact Person: Jennifer Staunton
Director Regulatory Affairs
Telephone: 219-718-1152

Date Prepared: January 9, 2025

Trade Name: CONDUIT™ SYNFIX™ Evolution Secured Spacer System

Device Class: Class II

Product Code: OVD, MAX

Common Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Classification Name: Intervertebral Body Fusion Device

Regulation Number: 21 CFR 888.3080

Classification Panel: Orthopaedic and Rehabilitation Devices Panel (87)

Primary Predicate: Synthes SYNFIX™ Evolution Secured Spacer System (K150673)

Additional Predicates:

DePuy Synthes EIT Cellular Titanium® ALIF Cage (K201605)
EIT Emerging Implant Technologies, GmbH Cellular Titanium® ALIF Cage (K170503)
Stryker Monterey™ AL Interbody System (K201585)

Device Description: The CONDUIT SYNFIX Evolution Secured Spacers are intervertebral body fusion devices intended for lumbar interbody fusion (ALIF). Four Screws are inserted through the anteriorly-located Plate into the adjacent vertebral bodies. The Screws lock securely to the Plate using a tapered-thread locking mechanism.

The CONDUIT SYNFIX Evolution Cages are made from Ti-6Al-4V

K250072
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Page 6

ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Indications for Use: The CONDUIT™ SYNFIX™ Evolution Secured Spacer System is a stand-alone anterior interbody fusion device with a microscope roughened surface and micro and nano-scale features indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the CONDUIT SYNFIX Evolution can be packed with autograft. If used with less than the four integrated bone screws, or for hyperlordotic implants (>20Deg), implants must be used with supplemental fixation systems cleared by the FDA for use in the lumbosacral spine.

Materials: The components are manufactured from medical grade Titanium. The Cage from standard specification for Ti-6Al-4V ELI using full-melt powder bed fusion in conformance with ASTM F3001. The Plate is manufactured from Ti-6Al-4V per ASTM F136 and bone Screws are supplied by DePuy Synthes and manufactured from Ti-6Al-7Nb (ISO 5832).

Comparison to Predicate Device: The substantial equivalence of the subject device to the predicates identified above is based upon the equivalence of intended use, design (fundamental scientific technology), performance, sterility, and biocompatibility.

Performance Data: Mechanical testing, including static and dynamic axial compression per ASTM F2077-24, static and dynamic compression shear per ASTM F2077-24, subsidence per ASTM F2267-24, and expulsion was performed to provide data to support a substantial equivalence

K250072
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determination. The mechanical testing was performed to characterize the properties and functionality of the system, as well as to allow comparison with established acceptance criteria.

Additionally, the subject device was evaluated for magnetically induced displacement force per ASTM F2052-21, magnetically induced torque per ASTM F2213-17, MR image artifact per ASTM F2119-24 and RF-induced heating per ASTM F2182-19e2 to support the MR Conditional labeling.

Clinical Test Summary: No clinical data was necessary to demonstrate substantial equivalence, nor safety and effectiveness of this system.

Conclusion: Based on the predicate comparison of intended use, indications, technological characteristics, and device performance, the CONDUIT SYNFIX Evolution Secured Spacer System has demonstrated substantial equivalence to the identified predicate device systems.

K250072
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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.