(62 days)
The Firebird Spinal Fixation System is intended for posterior, noncervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
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.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
The Firebird Spinal Fixation System is a temporary, multiple component system 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 system is attached to the vertebral body bv means of screw . fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The Firebird Spinal Fixation System implants are not compatible with components or metal from any other manufacturer's system.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System as indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
The Orthofix Firebird Spinal Fixation System is a Class III preamendment device (Pedicle screw spinal system, 21 CFR 888.3070) designed for posterior, non-cervical pedicle fixation as an adjunct to fusion.
Here's an analysis of the acceptance criteria and supporting evidence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Substantial Equivalence (Overall Safety and Effectiveness) | "The Firebird Spinal Fixation System were shown to be substantially equivalent to previously cleared devices with respect to intended use, design, function, materials, and performance." | Special K130176 Summary |
| Mechanical Performance (Rod Connectors) | "The Orthofix Firebird Spinal Fixation System proposed rod connectors are substantially equivalent to the predicate devices based on axial grip and torque verification, FEA simulation, and material characterization." | Mechanical Testing, FEA Simulation, Material Characterization (detailed results not provided in summary) |
| Material Compatibility | "Titanium alloy per ASTM F136 and Cobalt-Chrome per ASTM F1537." | Material Specification/Testing |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify sample sizes for mechanical testing or FEA simulations, nor does it indicate the provenance of any data beyond general material specifications. This submission is for a Special 510(k), which typically relies heavily on comparison to a predicate device and may not require extensive new testing if modifications are minor and proven equivalent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This 510(k) summary is for a spinal fixation system, not an AI or imaging device that would typically involve human expert ground truth establishment for diagnostic accuracy. Therefore, this information is not applicable and not provided.
4. Adjudication Method for the Test Set
As this is not an AI or imaging device requiring human expert review for diagnostic accuracy, an adjudication method is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human interpretation is a key component, often with and without AI assistance. This device is a surgical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study (algorithm only) was not done. This is not an AI-driven device. The "performance" assessment refers to the mechanical and material characteristics of the implant itself, not an algorithm's output.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established through:
- Material Specifications: Adherence to established ASTM standards (ASTM F136 for titanium alloy and ASTM F1537 for cobalt-chrome).
- Mechanical Performance Standards: Verification against established industry standards or predicate device performance for axial grip and torque.
- Engineering Principles: Finite Element Analysis (FEA) simulation.
8. The Sample Size for the Training Set
This is not applicable. This submission concerns a physical medical device (spinal implant), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no AI training set for this device.
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Orthofix Firebird Spinal Fixation System Special 510(k)
510(k) Summary
MAR 2 8 2013
| Submitter: | Orthofix, Inc. |
|---|---|
| 3451 Plano Parkway | |
| Lewisville, TX 75056 | |
| Contact: | Jacki Geren |
| Regulatory Affairs Specialist | |
| Orthofix, Inc. | |
| 214.937.2100 (phone) | |
| 214.937.3322 (fax) | |
| jackigeren@orthofix.com | |
| Date Prepared: | September 20, 2012 |
| Prepared By: | Jacki Geren |
| Regulatory Affairs Specialist | |
| Orthofix Inc. | |
| Product Code(s): | NKB; MNI; MNH |
| Classification Name: | Pedicle Screw Spinal System |
| Device Class: | Class III Preamendment Device, CFR 888.3070 - Pedicle screwspinal system - * Class III Summary and Certification Required |
| Classification Panel: | Orthopedics |
| Proprietary Name: | Firebird Spinal Fixation System |
| Device Description: | The Firebird Spinal Fixation System is a temporary, multi |
The Firebird Spinal Fixation System is a temporary, multiple component system 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 system is attached to the vertebral body bv means of screw . fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The Firebird Spinal
1
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Orthofix Firebird Spinal Fixation System Special 510(k)
Fixation System implants are not compatible with components or metal from any other manufacturer's system.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System as indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
Indications For Use:
The Firebird Spinal Fixation System is intended for posterior, noncervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
- a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- b) spondylolisthesis,
- c) trauma (i.e., fracture or dislocation),
- d) spinal stenosis,
- e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- ದಿ tumor,
- g) pseudoarthrosis, and
- h) failed previous fusion
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.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
Titanium alloy per ASTM F136 and Cobalt-Chrome per ASTM F1537.
Predicate Devices:
Materials:
The Firebird Spinal Fixation System is substantially equivalent to the previously cleared Firebird Spinal Fixation System (K122901)
2
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3
Orthofix Firebird Spinal Fixation System Special 510(k)
Substantial Equivalence: The Orthofix Firebird Spinal Fixation System proposed rod connectors are substantially equivalent to the predicate devices based on axial grip and torque verification, FEA simulation, and material characterization.
Conclusion:
The Firebird Spinal Fixation System were shown to be substantially equivalent to previously cleared devices with respect to intended use, design, function, materials, and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2013
Orthofix. Incorporated % Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K130176
Trade/Device Name: Firebird Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: February 28, 2013 Received: March 1, 2013
Dear Ms. Geren:
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 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
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Page 2 - Ms. Jacki Geren
forth in the quality systems (OS) 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/ucm115809.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.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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Orthofix Firebird Spinal Fixation System Special 510(k)
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known): | K130176 |
|---|---|
| --------------------------- | --------- |
| Device Name: | Firebird Spinal Fixation System |
|---|---|
| -------------- | --------------------------------- |
| Indications for Use: |
|---|
| ---------------------- |
The Firebird Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
- spinal stenosis, d)
- e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor, t)
- g) pseudoarthrosis, and
- h) failed previous fusion
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
The Phoenix MIS Spinal 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.
| Prescription Use: | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
and/or
Over-The-Counter (Part 21 CFR 801 C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page 1 of of 1 a
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130176
§ 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.