The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis, and
failed previous fusion

When used for fixation to the illium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to be used with autograft or allograft.

Device Description

The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K153428) are temporary, multiple component systems comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

AI/ML Overview

This FDA 510(k) premarket notification describes the Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, and Firebird NXG Spinal Fixation System by Orthofix Inc. The submission is a Special 510(k) for additions and modifications to an already cleared system (K153428).

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the additions and modifications to the device "do not change the previously cleared Firebird Spinal Fixation System (K153428) indications for use, contraindications, warnings or precautions." This implies that the acceptance criteria for the modified devices are the same as those established for the predicate device K153428. The primary performance metric mentioned is mechanical integrity under dynamic compression bending.

The acceptance criteria appear to be meeting or exceeding the performance of the predicate device (K153428) and compliance with the ASTM F1717-15 standard for spinal implant constructs.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Performance	Must meet or exceed the dynamic compression bending requirements of ASTM F1717-15 for spinal implant constructs. Performance must be similar to or better than the predicate device (K153428).	Mechanical testing was conducted on the subject devices (Reduction Body, Mono-Axial Lateral Offset, Front Loading, Top Loading & Axial Rod Connectors, Anodized Straight and Pre-Lordosed titanium alloy Lined Rods) using Dynamic Compression Bending per ASTM F1717-15. The Low Profile Offset was justified based on the worst-case Mono-Axial Lateral Offset construct.
Technological Characteristics and Equivalence Rating	Technological characteristics (design, dimensions, intended use, materials, performance) must be similar to the predicate device (K153428) with no significant differences that would adversely affect use.	"The performance and technological characteristics of the subject devices are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the subject devices and the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K153428) which would adversely affect the use of the product."
Indications for Use, Contraindications, Warnings, Precautions	The additions and modifications must not change the previously cleared indications for use, contraindications, warnings, or precautions of the Firebird Spinal Fixation System (K153428).	"The above listed additions and modifications do not change the previously cleared Firebird Spinal Fixation System (K153428) indications for use, contraindications, warnings or precautions."

Study Details

The document describes non-clinical mechanical testing, not a clinical study involving human patients or ground truth established by experts in a diagnostic context.

Sample size used for the test set and the data provenance: The document does not specify a numerical sample size for the mechanical tests. It lists the types of components tested (Reduction Body, Low Profile Offset, Mono-Axial Lateral Offset, Front Loading, Top Loading & Axial Rod Connectors, Anodized Straight and Pre-Lordosed titanium alloy Lined Rods). The data provenance is internal testing performed by Orthofix Inc. on manufactured device components. It is not prospective or retrospective patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This was a mechanical engineering study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the physical performance under specified ASTM mechanical testing standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was a mechanical engineering study, not a study requiring clinical adjudication.
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 device is a spinal fixation system, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a spinal fixation system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this engineering study is defined by established mechanical testing standards (ASTM F1717-15) and comparison to the performance of the predicate device.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is a mechanical engineering study for a physical medical device, not an AI/machine learning product.
How the ground truth for the training set was established: Not applicable. There is no training set.

Summary

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

Orthofix Inc. Ms. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Mav 5, 2017

Re: K171082

Trade/Device Name: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System. Firebird NXG Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: April 10, 2017 Received: April 11, 2017

Dear Ms. Koch:

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171082

Device Name

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System

Indications for Use (Describe)

degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

1. spondylolisthesis,
1. trauma (i.e., fracture or dislocation),
1. spinal stenosis,
1. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
1. tumor,
1. pseudoarthrosis, and
1. failed previous fusion

When used for fixation to the illium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

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.

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Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. Below the word "ORTHOFIX" is the word "Firebird" in a smaller font size.

irebird Spinal Fixation System/Phoenix MIS Spinal Fixation System JANUS Midline Fixation Screw Phoenix CDX MIS Spinal Fixation System Firebird NXG Spinal Fixation System

510(k) SUMMARY

Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System JANUS Midline Fixation Screw Phoenix CDX MIS Spinal Fixation System Firebird NXG Spinal Fixation System

510(k) Owner Information

510(k) Owner InformationName:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214-937-2100214-937-3322jackikoch@orthofix.com
Registration Number:	2183449
Contact Person:	Jacki Koch
Date Prepared:	April 28, 2017
Name of DeviceTrade Name / ProprietaryName:	Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemJANUS Midline Fixation ScrewPhoenix CDX MIS Spinal Fixation SystemFirebird NXG Spinal Fixation System
Common Name:	Spinal Fixation System
Product Code:	NKB; KWP, KWQ
Regulatory Classification:	Class II - 21 CFR § 888.3070 and 21 CFR § 888.3050
Review Panel:	Orthopedic Device Panel
Primary Predicate Device:	Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System(K153428)
Additional Predicate:	Spinal Fixation System (K080407)

Reason for 510(k) Submission:

Orthofix is submitting this Special 510(k) request for the following medical devices which are:

1. Addition of new Reduction Body
1. Addition of new Low Profile Offset
1. Modification of the Mono-Axial Lateral Offset
1. Addition of new Front Loading and Axial Rod Connectors

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Image /page/5/Picture/1 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A registered trademark symbol is present next to the "X" in "ORTHOFIX".

rebird Spinal Fixation System/Phoenix MIS Spinal Fixation System JANUS Midline Fixation Screw Phoenix CDX MIS Spinal Fixation System Firebird NXG Spinal Fixation System

1. Modification to the Top Loading Rod Connector
1. Modification to all Straight and Pre-Lordosed titanium alloy (Ti-6AL-4V ELI) Lined Rods

The above listed additions and modifications do not change the previously cleared Firebird Spinal Fixation System (K153428) indications for use, contraindications, warnings or precautions. Furthermore, the surgical approach and implantation technique remains the same as the previously cleared Firebird Spinal Fixation System (K153428).

Device Description

Intended Use / Indications for Use

degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

1. spondylolisthesis.
1. trauma (i.e., fracture or dislocation),
1. spinal stenosis,
1. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
1. tumor,
1. pseudoarthrosis, and
1. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

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Image /page/6/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. There is a registered trademark symbol after the "X" in "ORTHOFIX".

rebird Spinal Fixation System/Phoenix MIS Spinal Fixation System JANUS Midline Fixation Screw Phoenix CDX MIS Spinal Fixation System Firebird NXG Spinal Fixation System

approach. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to be used with autograft or allograft.

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

The technological characteristics of the subject devices are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the subject devices and the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K153428) which would adversely affect the use of the product.

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

Mechanical testing was conducted on the subject devices as listed below in Table 1: Mechanical Performance Testing

Subject Device	Mechanical Testing
Reduction Body	Dynamic Compression Bending per ASTMF1717-15
Low Profile Offset	Justification based upon worst case Mono-AxialLateral Offset construct
Mono-Axial Lateral Offset	Dynamic Compression Bending per ASTMF1717-15
Front Loading, Top Loading & Axial RodConnectors	Dynamic Compression Bending per ASTMF1717-15
Anodized Straight and Pre-Lordosedtitanium alloy (Ti-6AL-4V ELI) Lined Rods	Dynamic Compression Bending per ASTMF1717-15

Table 1: Mechanical Performance Testing

Basis of Substantial Equivalence

The performance and technological characteristics of the subject devices are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the subject devices and the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K153428) which would adversely affect the use of the product.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.