(73 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "spinal fixation system" intended for various spinal indications, acting as an "adjunct to fusion." This indicates its role in treating or alleviating a medical condition.
No.
The Firebird Spinal Fixation System is a surgical implant designed to stabilize the spine and aid in fusion, not to diagnose medical conditions.
No
The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use components" including "rods, screws, screw bodies, offset head, lateral offsets, and connectors," all made of "titanium alloy." This indicates a physical hardware device, not software only.
Based on the provided information, the Firebird Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant system for spinal fixation, used in vivo (within the body) to stabilize the spine. IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details components like rods, screws, and connectors that are implanted into the spine. This is consistent with a surgical implant, not a device for analyzing biological samples.
- Anatomical Site: The device is used on the posterior, non-cervical pedicle, which is an anatomical location within the body.
- Lack of IVD characteristics: There is no mention of analyzing biological specimens, diagnostic testing, or providing information for diagnosis based on in vitro analysis.
Therefore, the Firebird Spinal Fixation System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The Firebird Spinal 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:
- 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 .
The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The components include rods, screws, screw bodies, offset head, lateral offsets, and connectors. The system is attached to the vertebral body by means of screws to the non-The spinal construct is completed by cervical spine.
connecting the screws with titanium alloy or cobalt chrome rods.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical
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)
FEA simulation was performed on the worst case subject Firebird Spinal Fixation System and predicate Firebird Spinal Fixation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K081684, K082797, K092624, K100044
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
DEC
3 2012
Image /page/0/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a stylized symbol above the word "ORTHOFIX". The symbol is an abstract shape, possibly representing a bone or joint, and the word "ORTHOFIX" is written in a bold, sans-serif font.
510(k) Summary
Submitter:
Contact:
3451 Plano Parkway Lewisville, TX 75056 Jacki Geren
Orthofix, Inc.
Regulatory Affairs Specialist Orthofix, Inc. 214.937.2100 (phone) 214.937.3322 (fax) jackigeren@orthofix.com
1331 H Street NW, 12th Floor Washington, DC 20005 202.552.5800 (phone)
Firebird Spinal Fixation System Phoenix MIS Spinal Fixation System
September 20, 2012
Date Prepared:
Prepared By:
Product Code(s):
NKB: MNI: MNH
Pedicle Screw Spinal System Classification Name:
Device Class:
Class III Preamendment Device, 888.3070 - Pedicle screw spinal system - *Class III Summary and Certification Required
Musculoskeletal Clinical Regulatory Advisers, LLC
Classification Panel: Orthopedics
Proprietary Name:
Device Description:
The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The components include rods, screws, screw bodies, offset head, lateral offsets, and connectors. The system is attached to the vertebral body by means of screws to the non-The spinal construct is completed by cervical spine.
1
connecting the screws with titanium alloy or cobalt chrome rods.
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.
The Firebird Spinal 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:
- . 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 .
The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS 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.
Titanium alloy per ASTM F136 and Cobalt-Chrome per ASTM F1537.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are substantially equivalent to the previously cleared Firebird Spinal Fixation System (K081684, K082797, K092624, K100044).
Materials:
Predicate Devices:
Indications For Use:
2
Substantial Equivalence: . FEA simulation was performed on the worst case subject Firebird Spinal Fixation System and predicate Firebird Spinal Fixation System.
The Firebird Spinal Fixation System and Phoenix MIS Conclusion: 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2012
Orthofix. Incorporated % Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K122901
Trade/Device Name: Firebird Spinal Fixation System Regulatory Number: 21 CFR 888.3070 Regulatory Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: September 20, 2012 Received: September 21, 2012
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 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.
4
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/Resourcesfor You/Industry/default.htm.
Sincerely yours, Erin I Keith
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) K122901:
Device Name: Firebird Spinal Fixation System Phoenix MIS Spinal Fixation System
The Firebird Spinal 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:
- 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 .
The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS 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.
ج Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR -
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Deice Evaluation (ODE)
Ronald P. Jean
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122901