The FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

Device Description

FORZA Ti Spacer System is comprised of a variety of 3D Titanium printed implants (conforming to ASTM F3001) that have porous end plates and a functional gradient porous structure. The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium porous structure have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. FORZA Ti Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

FORZA Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. FORZA Ti implants are provided sterile.

AI/ML Overview

The Orthofix FORZA® Ti Spacer System is an intervertebral body fusion device. Based on the provided FDA 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are described below:

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

Acceptance Criteria (Performance Standard)	Reported Device Performance (FORZA® Ti Spacer System)
Mechanical testing per ASTM F2077 (static and dynamic axial compression, static and dynamic compression shear)	Passed, results demonstrated substantial equivalence to predicate.
Subsidence testing per ASTM F2267	Passed, results demonstrated substantial equivalence to predicate.
Characterization of particles per ASTM F1877	Passed, results demonstrated substantial equivalence to predicate.

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

The document does not specify a "test set" in the context of clinical trial data provenance (e.g., country of origin, retrospective/prospective) for this device. The evaluation of this device for 510(k) clearance was based on mechanical testing, not clinical data from patients. Therefore, the "sample size" refers to the number of devices or materials tested during these mechanical evaluations. The exact number of units tested for each specific mechanical test (ASTM F2077, F2267, F1877) is not explicitly stated in this summary.

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

This information is not applicable. The device's evaluation was based on mechanical engineering standards (ASTM) for performance testing, not on human expert interpretation of clinical images or patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to resolve discrepancies in image interpretation or clinical diagnosis. This device was evaluated through mechanical testing against established engineering 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

This information is not applicable. The device is a surgical implant (intervertebral body fusion device), not an imaging or diagnostic AI tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to its evaluation.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance was established by recognized engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F1877). Successful adherence to these standards, and demonstration of substantial equivalence to a predicate device that also meets these standards, constitutes the "ground truth" for its safety and effectiveness in its intended mechanical function.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm and does not involve a training set in the machine learning sense. The tests are mechanical evaluations of the physical product.

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

This information is not applicable for the same reason as above.

Summary

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March 3, 2021

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

Re: K203576

Trade/Device Name: FORZA® Ti Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 4, 2021 Received: February 5, 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,

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

510(k) Number (if known) K203576

Device Name FORZA® Ti Spacer System

Indications for Use (Describe)

The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

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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510(k) Summary	K203576
Device Trade Name:	FORZA® 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:	February 4, 2021
Registration Number:	2183449
Product Code:	MAX
Classifications:	Class II - 21 CFR §888.3080, Intervertebral body fusiondevice
Primary Predicate:	K200052 – FORZA PTC Spacer System, SE 4/9/2020

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

Device Description:

FORZA Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. FORZA Ti implants are provided sterile.

Indications for Use and Intended Use:

FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondvlolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels. FORZA Ti Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system.

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Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

Performance Testing Summary:

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

Substantial Equivalence:

The subject device is substantially equivalent to the FORZA PTC Spacer System (K200052) predicate device with respect to indications, design, materials, function, and performance.

Conclusion:

FORZA 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 FORZA PTC Spacer System (K200052).

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.