The FORZATM 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 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZATM Spacer System is intended for use with autograft and supplemental fixation system. As an example, the supplemental fixation system that may be used is the Orthofix Inc. Firebird™ Pedicle Screw System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZATM Spacer System.

Device Description

The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F-2026 with Tantalum markers as described by ASTM F-560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, Tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The implants are offered in two geometric shapes: straight and curved, and offered in lordotic profiles to restore the natural curvature of the spine. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with supplemental fixation system. The FORZATM Spacer System implants are provided sterile. The FORZATM Spacer System trials and instruments are provided non-sterile.

AI/ML Overview

The Orthofix Inc. FORZA™ Spacer System is an intervertebral body fusion device. The acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (FORZA™ Spacer System)
Function/Design	Restore biomechanical integrity of the spinal column by providing fusion at one or two contiguous levels in the lumbar spine (L2-S1), used with autograft material and supplemental fixation system.	Restores biomechanical integrity of the spinal column by providing fusion at one or two contiguous levels in the lumbar spine (L2-S1). Intended for use with autograft and supplemental fixation system.
Implant Width	Comparable to predicate devices (9-11mm for PILLAR, 9-15mm for Lumbar I/F Cage).	9-11mm
Implant Length	Comparable to predicate devices (23-33mm for PILLAR, 21-25mm for Lumbar I/F Cage).	23-33mm
Implant Heights	Comparable to predicate devices (6-16mm for PILLAR, 9-17mm for Lumbar I/F Cage).	6-16mm
Lordotic Angles	Comparable to predicate devices (0 and 8° for PILLAR, Parallel and Wedged for Lumbar I/F Cage).	0, 4 and 8°
Configuration	Hollow Cage for use with supplemental fixation.	Hollow Cage for use with supplemental fixation.
Material	Biocompatible and mechanically suitable (PEEK with Tantalum or Titanium markers).	Polyetheretherketone (PEEK, ASTM F-2026) with Tantalum markers (ASTM F-560).
Static Compression	Meet or exceed performance of predicate devices as per ASTM F2077-03.	Test results demonstrated substantial equivalence.
Dynamic Compression	Meet or exceed performance of predicate devices as per ASTM F2077-03.	Test results demonstrated substantial equivalence.
Subsidence	Meet or exceed performance of predicate devices as per ASTM F2267-04.	Test results demonstrated substantial equivalence.
Sterility	Demonstrated sterility for pre-sterilized implants.	Addressed with sterilization verification testing.

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

The document describes non-clinical mechanical testing.
Sample Size for Test Set: Not explicitly stated as a number of devices/implants, but it refers to "mechanical testing of the Orthofix Inc. FORZATM Spacer System." The testing was conducted "in accordance to ASTM F2077-03 standard for Static & Dynamic Compression testing and ASTM F2267-04 standards for Subsidence testing." ASTM standards typically specify the number of samples required for such tests.
Data Provenance: The data is generated from laboratory mechanical testing of the device itself. It is not patient data, thus, country of origin or retrospective/prospective designation are not applicable in this context.

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

This information is not applicable as the ground truth for mechanical testing is established by adherence to universally accepted engineering standards (ASTM F2077-03 and ASTM F2267-04) and the physical properties of the materials and device design, not by expert human interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the test set involves mechanical engineering tests against objective standards, not interpretation by human adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intervertebral spacer) and relies on mechanical testing and comparison to predicate devices, not on a study with human readers interpreting imaging or clinical outcomes.

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

This information is not applicable. This device is a physical implant, not an algorithm or a software device. Therefore, the concept of "standalone performance" in the context of AI algorithms does not apply.

7. The Type of Ground Truth Used

The ground truth for the mechanical performance testing is established by objective engineering standards and specifications. Specifically, the device's performance was compared against the requirements and methodologies outlined in:
- ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) for Static and Dynamic Compression.
- ASTM F2267-04 (Standard Test Method for Measuring the Compressive Properties of PEEK and Tantalum Markers) for Subsidence.
- The "ground truth" for substantial equivalence is also derived from the established characteristics and performance of the identified predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of a physical medical device submission based on mechanical testing and predicate device comparison. Device design and manufacturing processes are iteratively developed, but this is not analogous to an AI training set.

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

This information is not applicable for the same reasons as #8.

Summary

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510(k) SUMMARY

	Orthofix Inc. FORZA Spacer SystemMAR 2 3 2011
Submitter Information
Name:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214.937.2000214.937.3322darlachew@orthofix.com
Registration Number:	3008524126
Contact Person:	Darla ChewDirector of Regulatory Affairs
Date Prepared:	March 21, 2011
Name of DeviceTrade Name / ProprietaryName:	きFORZA™ Spacer System
Common Name:	Intervertebral Body Fusion Device
Product Code:	MAX - Intervertebral Fusion Device with Bone Graft,Lumbar
Regulatory Classification:	Class II - 888.3080 - Intervertebral Body Fusion Device
Review Panel:	Orthopedic Device Panel
Predicate Devices:	Blackstone, PILLAR Spacer System, K081177, SE 7-23-08DePuy AcroMed, Inc. Lumbar I/F Cage® with VSPSpine System: P960025 (i.e., Brantigan Cage)Abbott, Ardis Spacer, K073202, SE 1-30-2008Advance Medical Technology, Distractable Wave Cage,K083626. SE10-19-2009

Reason for 510(k) Submission: New product offering

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Device Description

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with supplemental fixation system. The FORZA Spacer System implants are provided sterile. The FORZATM Spacer System trials and instruments are provided non-sterile.

Intended Use / Indications for Use

The FORZA™ 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 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA™ Spacer System is intended for use with autograft and supplemental fixation system. As an example, the supplemental fixation system that may be used is the Orthofix / Blackstone Medical, Inc. Firebird™ Pedicle Screw System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZATM Spacer System.

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Characteristic	FORZA™ SpacerSystem(Under Review)	Orthofix Inc.,PILLAR SpacerSystem (K081177)	DePuy AcroMed, Inc.Lumbar I/F Cage®with VSP SpineSystem: P960025
Function /Design	Restore Biomechanicalintegrity of the spinalcolumn by providingfusion at one or twocontiguous levels in thelumbar spine (L2-S1).The device is intendedto be used withautograft material andsupplemental fixationsystem.	Restore Biomechanicalintegrity of theanterior, middle andposterior spinalcolumn even in theabsence of fusion for aprolonged period. Thedevice is intended tobe used with bonegraft material.	The Lumbar I/F Cagedevice indicated for anopen posterior approachusing autogenous bonegraft at one or twospinal levels from L2-S1whose condition requiresthe use of interbodyfusion combined withposterolateral fusionand posterior pediclescrew fixation.
Implant Size(s)	Width 9–11mmLength 23–33mm	Width 9–11mmLength 23–33mm	Width 9–15mmLength 21–25mm
Implant Heights	6–16mm	6–16mm	9–17mm
Lordotic Angles	0, 4 and 8°	0 and 8°	Parallel and Wedged
Configuration	Hollow Cage for usewith supplementalfixation	Hollow Cage for usewith supplementalfixation	Hollow Cage for usewith supplementalfixation
Material	Polyetheretherketone(PEEK, ASTM F-2026)Tantalum marker(ASTM F-560)	Polyetheretherketone(PEEK, ASTM F-2026)Titanium marker(ASTM F-67)	Polyetherketone EtherKetone Ketone(PEKEKK) withPolyacrylonitrile (PAN)carbon fibers withTantalum markers

Summary of the Technological Characteristics of the Device Compared to the Predicate Device

PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Characteristic	Standard / Test/ FDA Guidance
Static Compression	ASTM F 2077-03
Dynamic Compression	ASTM F 2077-03
Subsidence	ASTM F2267-04

Performance Data Summary

Mechanical testing of the Orthofix Inc. FORZATM Spacer System was conducted in accordance to ASTM F2077-03 standard for Static & Dynamic Compression testing and ASTM F2267-04 standards for Subsidence testing. Test results demonstrated that

Section 4 - 510(k) Summary Section Page 3 of 4

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the FORZA Space system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

Substantial Equivalence

The FORZATM Spacer System share the same intended use, similar indications, technological characteristics and principles of operation with PILLAR Spacer System (K081177) and the DePuy Acromed, Inc. Lumbar I/F Cage® with VSP Spine System (P960025). FORZA system has similar mechanical properties to DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System (P960025) and Pioneer Rotate Option implant (K073177) predicate device as stated above.

The difference between FORZA Space System implants and its predicate devices consist in technological differences i.e. the FORZA implants are distributed sterile and have minor dimensional differences. FORZA dimensional and sterility differences proposed in this submission are addressed with sterilization and mechanical verification testing. Based on test results, these changes do not present any new / additional issues of safety or effectiveness, the FORZA™ Spacer System is substantially equivalent to its predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Orthofix, Inc. % Ms. Darla Chew Director of Regulatory Affairs 3451 Plano Parkway Lewisville, Texas 75056

MAR 2 3 2011

Re: K103111

Trade/Device Name: FORZA™ Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 18, 2011 Received: March 21, 2011

Dear Ms. Chew:

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. 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

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdaggov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Aling B. Rote

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103111

Device Name: FORZA™ Spacer System (Intervertebral body fusion device)

Indications for Use:

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZATM Spacer System.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103111

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.