K252982 · Avalign Technologies, Inc. · OVE · Jun 18, 2026 · Orthopedic
Device Facts
Record ID
K252982
Device Name
CONDUIT™ ZERO-P™ VA Secured Spacer System
Applicant
Avalign Technologies, Inc.
Product Code
OVE · Orthopedic
Decision Date
Jun 18, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The CONDUIT ZERO-P VA Spacer is a stand-alone anterior cervical interbody fusion device with a microscopic roughened surface and micro and nano-scale features indicated for use at one or two levels of the cervical spine (C2-T1) in skeletally mature patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The interior of the spacer component should be packed with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft and implanted via an anterior approach.
Device Story
Stand-alone anterior cervical interbody fusion device; provides structural support and stabilization for cervical spine fusion. Device consists of 3D-printed titanium spacer with porous internal structure and integrated fixation mechanism (screws, locking pins, springs). Implanted via anterior approach; screws inserted at convergent/variable angles into adjacent vertebrae; one-step blocking mechanism secures screws. Hollow geometry allows packing with autogenous/allogeneic bone graft. Used by surgeons in clinical/OR settings to treat cervical pathology; promotes fusion through mechanical stability and bone graft containment. Benefits include stabilization of spinal segments and restoration of disc height.
Clinical Evidence
No clinical data was necessary to demonstrate substantial equivalence; safety and effectiveness were supported by bench testing only.
Technological Characteristics
Intervertebral body fusion device; additive manufactured (Selective Laser Melting) Ti-6Al-4V ELI (ASTM F3001). Features micro/nano-scale surface roughness. Includes Ti-6Al-4V (ASTM F136) locking pins/screw catch, Phynox (ASTM 1058) springs, and Ti-6Al-7Nb (ISO 5832) bone screws. Mechanical testing per ASTM F2077-24 and F2267-24. MRI conditional per ASTM F2052-21, F2213-17, F2119-24, and F2182-19e2.
Indications for Use
Indicated for skeletally mature patients requiring anterior cervical interbody fusion at one or two levels (C2-T1) for cervical disc disease, instability, trauma (fractures), deformity (kyphosis, lordosis, scoliosis), cervical spondylotic myelopathy, spinal stenosis, or failed previous fusion. Requires 6 weeks of prior non-operative treatment.
Regulatory Classification
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.
Special Controls
*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.
Globus Medical Inc. HEDRON™ Cervical Spacers (K191243)
CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072)
Submission Summary (Full Text)
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June 18, 2026
Avalign Technologies, Inc.
Jennifer Staunton
Director Regulatory Affairs
8727 Clinton Park Dr.
Fort Wayne, Indiana 46825
Re: K252982
Trade/Device Name: CONDUIT™ ZERO-P™ VA Secured Spacer System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVE
Dated: May 20, 2026
Received: May 20, 2026
Dear Ms. 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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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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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.
510(k) Number (if known)
K252982
Device Name
CONDUITTM ZERO-P VA Secured Spacer System
Indications for Use (Describe)
The CONDUIT ZERO-P VA Spacer is a stand-alone anterior cervical interbody fusion device with a microscopic roughened surface and micro and nano-scale features indicated for use at one or two levels of the cervical spine (C2-T1) in skeletally mature patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion.
Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The interior of the spacer component should be packed with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft and implanted via an anterior approach.
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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EF
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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:** | September 17, 2025 |
| **Trade Name:** | CONDUIT™ ZERO-P™ VA Secured Spacer System |
| *Device Class:* | Class II |
| *Product Code:* | OVE |
| *Common Name:* | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| *Classification Name:* | Intervertebral Body Fusion Device |
| *Regulation Number:* | 21 CFR 888.3080 |
| *Classification Panel:* | Orthopaedic and Rehabilitation Devices Panel (87) |
| **Primary Predicate:** | Synthes Zero-P Variable Angle (K112068) |
| **Additional Predicates:** | EIT Cellular Titanium® Cervical Cage (K170503) EIT Cellular Titanium® Cervical Cage (K201605) Globus Medical Inc. HEDRON™ Cervical Spacers (K191243) CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072) |
| **Device Description:** | The CONDUIT ZERO-P VA Secured Spacers are intervertebral body fusion devices intended for anterior cervical interbody fusion. Two screws are inserted at convergent and variable angles into adjacent vertebral bodies with a one step blocking mechanism. The CONDUIT ZERO-P VA Secured Spacer System is available in various heights and geometries to suit individual pathology and anatomical conditions. The CONDUIT ZERO-P VA 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 and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The 3D Printed Conduit Cellular Titanium Cages have a microscopic |
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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.
# **Indications:**
The CONDUIT™ ZERO-P™ VA Spacer is a stand-alone anterior cervical interbody fusion device with a microscopic roughened surface and micro and nano-scale features indicated for use at one or two levels of the cervical spine (C2-T1) in skeletally mature patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion.
Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The interior of the spacer component should be packed with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft and implanted via an anterior approach.
# **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 pre-assembled blocking mechanism, consisting of Qty 2ea Screw Catch and Locking Pins are comprised of Ti-6Al-4V per ASTM F136, while the Springs are comprised of Phynox® per ASTM 1058. The 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 performance, including static and dynamic axial compression per ASTM F2077-24, static and dynamic compression shear per ASTM F2077-24, static and dynamic torsion per ASTM F2077-24 and subsidence per ASTM F2267-24, was assessed to support a substantial equivalence determination by characterizing the properties and functionality of the system and allowing comparison to established acceptance criteria.
Additionally, the subject device was evaluated for magnetically
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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™ ZERO-P™ VA Spacer has demonstrated substantial equivalence to the identified predicate devices.
