(240 days)
No reference devices were used in this submission
No
The summary 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 "posterior, non-cervical pedicle fixation" to treat various spinal conditions, indicating a direct therapeutic purpose.
No
The Firebird Spinal Fixation System is described as a "temporary, titanium alloy, multiple component system" used to "build a spinal implant construct" to aid in fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy" and lists physical components like rods, screws, and hooks. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant system for spinal fixation. It is used in the body to provide structural support and aid in fusion.
- Device Description: The description details physical components like rods, screws, and hooks, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic device used during surgery.
N/A
Intended Use / Indications for Use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non pedicle fixation (T1 - S2/Ilium). 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 a) confirmed by history and radiographic studies);
- Spondylolisthesis: b)
- Trauma (i.e., fracture or dislocation); C)
- Spinal stenosis: d)
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); e)
- f) Tumors;
- Pseudoarthrosis, and g)
- Failed previous fusion h)
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.
The Firebird 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 non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, KWP, MNH, MNI
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, 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 and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle, and non pedicle fixation (T1 - S2/Ilium)
Indicated Patient Age Range
skeletally mature patients, pediatric patients (adolescent idiopathic scoliosis)
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)
Mechanical testing for the subject Firebird Spinal Fixation System lined rods were conducted in accordance with ASTM F1717-14 Standard Test Method for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model and ASTM 1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Test results demonstrated that the subject lined rods are substantially equivalent to the predicate device Firebird Spinal Fixation System (K130932) which has the same intended use, similar indications, technological characteristics, and principles of operations
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.
No reference devices were used in this submission
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three faces in profile, representing health and well-being. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2015
Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K141186
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, OSH, MNI, MNH, KWP Dated: October 31, 2014 Received: November 6, 2014
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Jacki Geren
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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141186
Device Name Firebird Spinal Fixation System
Indications for Use (Describe)
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation (T1 - S2/ Ilium). 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) Tumors:
g) Pseudoarthrosis, and
h) 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.
The Firebird 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 non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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)
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Image /page/3/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol next to it. The abstract shape is made up of curved lines that form a circular shape with a gap in the middle.
510(k) Summary
| Name: | Orthofix Inc. |
|---|---|
| Address: | 3451 Plano Parkway |
| Lewisville, Texas 75056 | |
| Telephone Number: | 214-937-2000 |
| Fax Number: | 214-937-3322 |
| Email: | jackigeren@orthofix.com |
| Registration Number: | 3008524126 |
| Contact Person: | Jacki Geren |
| Regulatory Affairs Specialist | |
| Date Prepared: | May 6, 2014 |
| Name of Device | |
| Trade Name/Proprietary | |
| Name: | Firebird Spinal Fixation System |
| Common Name: | Spinal Fixation System |
| Product Code: | NKB; OSH; KWP; MNH; MNI |
| Regulatory Classification: | 21 CFR §888.3070 |
| Pedicle screw spinal system (Class III) | |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Orthofix Firebird Spinal Fixation System - K130932 (primary predicate) |
| LDR Spine USA SpineTune TL System - K120760 (additional predicate) | |
| No reference devices were used in this submission | |
| Reason for 510(k) Submission: | Modification to all straight titanium alloy (Ti-6AL-4V ELI) rods to place |
| a line longitudinally along the length of the rod to provide better | |
| identification of induced curvature. | |
| 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, 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 and ilium by means of screw or hook | |
| fixation to the non-cervical spine. The Firebird Spinal Fixation System | |
| consists of an assortment of rods, multi-axial and mono-axial pedicle | |
| screws, set screws, lateral offsets, bone screws, screw bodies, hooks and | |
| iliac connectors. |
4
Image /page/4/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, bold letters. The shape is a curved, three-dimensional design, and the word "ORTHOFIX" is in a sans-serif font, with a registered trademark symbol next to the "X".
Intended Use / Indications for Use:
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non pedicle fixation (T1 - S2/Ilium). 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 a) confirmed by history and radiographic studies);
- Spondylolisthesis: b)
- Trauma (i.e., fracture or dislocation); C)
- Spinal stenosis: d)
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); e)
- f) Tumors;
- Pseudoarthrosis, and g)
- Failed previous fusion h)
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.
The Firebird 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 non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Characteristics | Firebird Spinal Fixation
System
(Subject Device) | Predicate Device:
Firebird Spinal Fixation
System
(K130932) | Predicate Device:
LDR Spine USA
SpineTune TL System
(K120760) |
|------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| Device Name | Firebird Spinal Fixation
System | Firebird Spinal Fixation
System (K130932) | SpineTune TL System
(K120760) |
| Method of
Fixation | Non-Cervical Fixation | Non-Cervical Fixation | Non-Cervical Fixation |
| Implantation | Posterior Approach | Posterior Approach | Posterior Approach |
| Design | This system allows a
surgeon to build a spinal
implant construct | This system allows a
surgeon to build a spinal
implant construct | This system allows a
surgeon to build a spinal
implant construct |
| Material | Titanium alloy (Ti-6AL-
4V ELI) | Titanium Alloy (Ti-6AL-
4V ELI) | Titanium alloy |
| Longitudinal
Line on Rods | Yes | No | Yes |
Summary of Technological Characteristics of the Device Compared to the Selected Predicate Device
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Image /page/5/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol next to the word. The abstract shape is a curved, three-dimensional shape that resembles a stylized "O".
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
| Characteristics | Standard / Test / FDA Guidance |
|---|---|
| Static Torsion Test | N/A No change from the predicate device |
| Static Axial Compression Bending Test | N/A No change from the predicate device |
| Dynamic Axial Compression Bending Test | ASTM F1717-14 |
| Axial Rod Gripping Test | ASTM F1798-13 |
Performance Data Summary
Mechanical testing for the subject Firebird Spinal Fixation System lined rods were conducted in accordance with ASTM F1717-14 Standard Test Method for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model and ASTM 1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Test results demonstrated that the subject lined rods are substantially equivalent to the predicate device Firebird Spinal Fixation System (K130932) which has the same intended use, similar indications, technological characteristics, and principles of operations
Basis of Substantial Equivalence
The subject Firebird Spinal Fixation System straight titanium alloy (Ti-6AL-4V ELI) lined rods are substantially equivalent to the predicate devices based on indications for use, intended use, design, materials and function and mechanical performance.