(62 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for posterior, non-cervical pedicle fixation to support fusion using autograft or allograft, addressing conditions like degenerative disc disease, spondylolisthesis, and spinal stenosis, which are therapeutic in nature.
No.
The Firebird Spinal Fixation System is described as a "temporary, multiple component system" used for spinal fixation and fusion, acting as an "adjunct to fusion." Its primary function is to provide mechanical support and stabilization, not to diagnose medical conditions.
No
The device description explicitly states it is comprised of multiple components made of titanium alloy or cobalt chrome alloy, which are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Firebird Spinal Fixation System is described as a system of implants (screws, rods, etc.) made of titanium or cobalt chrome, designed to be surgically attached to the spine for fixation.
- Intended Use: The intended use is for posterior, non-cervical pedicle fixation as an adjunct to fusion. This is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, performing diagnostic tests, or providing diagnostic information.
Therefore, the Firebird Spinal Fixation System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB; MNI; MNH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 screw |
| spinal 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
1
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
2
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.
3
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
4
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
5
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)
Ronald和物園ean -S
Page 1 of of 1 a
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130176