The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini Ti Spacer System is intended for use with autograft comprised of cancellous and/ or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

Device Description

The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach. The CONSTRUX Mini Ti implants are provided sterile.

AI/ML Overview

The information provided describes the acceptance criteria and the study for the CONSTRUX Mini Ti Spacer System, a medical device, not an AI/ML powered device. Therefore, many of the typical AI/ML study questions, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable.

Here's a summary of the available information regarding the device's acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

For the CONSTRUX Mini Ti Spacer System, the "acceptance criteria" are implied by the mechanical testing standards, and the "reported device performance" is that the device met these standards and was found substantially equivalent to predicate devices.

Acceptance Criteria (Implied by Standard)	Reported Device Performance
Static Axial Compression (ASTM F2077)	Met standard
Dynamic Axial Compression (ASTM F2077)	Met standard
Static Compression Shear (ASTM F2077)	Met standard
Dynamic Compression Shear (ASTM F2077)	Met standard
Static Torsion (ASTM F2077)	Met standard
Dynamic Torsion (ASTM F2077)	Met standard
Subsidence (ASTM F2267)	Met standard
Characterization of Particles (ASTM F1877)	Met standard
Overall Equivalence to Predicate Devices	Substantially Equivalent

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes mechanical testing performed according to specified ASTM standards. These standards dictate the number of test specimens (samples) required for each test. However, the exact sample sizes used for each specific test (e.g., how many devices were subjected to static axial compression) are not explicitly stated in this document.

The "data provenance" is typically the results of in-vitro mechanical testing performed by the manufacturer, Orthofix Inc. This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable. For mechanical testing of medical devices, "ground truth" is established by the specifications and methodologies outlined in the ASTM standards themselves, and the measurements are taken by testing equipment and qualified technicians/engineers. There is no expert consensus involved in establishing ground truth for mechanical test results in this manner.

4. Adjudication Method for the Test Set

This question is not applicable as the "test set" refers to mechanical testing, not a clinical study involving human assessment that would require 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

This question is not applicable as the device is a spinal implant, not an AI/ML-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a spinal implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" relies on:

ASTM standards: The established methodologies and acceptance criteria defined within ASTM F2077, ASTM F2267, and ASTM F1877.
Physical measurements: The quantitative results obtained from the mechanical tests (e.g., force, displacement, wear).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical implant, not an AI/ML model that undergoes a "training" phase.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary

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March 18, 2021

Orthofix Inc. Natalia Volosen Regulatory Affairs Principal 3451 Plano Parkway Lewisville, Texas 75056

Re: K203342

Trade/Device Name: CONSTRUX Mini Ti Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 8, 2021 Received: March 9, 2021

Dear Ms. Volosen:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/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).

Sincerely,

Brent L. 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

510(k) Number (if known) K203342

Device Name CONSTRUX Mini Ti Spacer System

Indications for Use (Describe)

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

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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510(k) Summary

Device Trade Name:	CONSTRUX Mini Ti Spacer System
Manufacturer:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056, USAPhone: (214) 937-2145Fax: (214) 937-3322
Contact Person:	Ms. Natalia VolosenRegulatory Affairs Principalnataliavolosen@orthofix.com
Date Prepared:	January 20, 2021
Registration Number:	2183449
Product Code:	ODP
Classifications:	Class II - 21 CFR §888.3080, Intervertebral body fusiondevice
Primary Predicate:Additional Predicate:	K202666 – CONSTRUX™ Mini PTC Spacer System,SE 10/14/2020K193359 – SureMAX™ Family of Cervical Spacers,SE 1/3/2020

Reason for the 510(k) Submission: Addition of 3D printed interbody devices

Device Description:

Indications for Use and Intended Use:

The CONSTRUX Mini Ti Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental

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fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

Performance Testing Summary:

CONSTRUX Mini Ti spacer was evaluated via mechanical testing per ASTM F2077 (including static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion), ASTM F2267 (subsidence) and characterization of particles per ASTM F1877. The results demonstrated the performance of CONSTRUX Mini Ti spacer is substantially equivalent to the predicate devices.

Comparison of Technology:

CONSTRUX Mini Ti Spacer System have the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device CONSTRUX Mini PTC Spacer System (K202666) and SureMAXTM Family of Cervical Spacers (K193359).

Conclusion:

The subject device is substantially equivalent to the CONSTRUX Mini PTC Spacer System (K202666) primary predicate and SureMAX™ Family of Cervical Spacers (K193359) additional predicate with respect to indications, design, materials, function, and performance.

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.