(24 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which is a therapeutic purpose.
No
The device is described as a "spinal fixation system" intended for "immobilization and stabilization of spinal segments" as "an adjunct to fusion." It is a physical implant (rods, screws) used in surgery to treat existing conditions, not to diagnose them.
No
The device description explicitly states it is comprised of "multiple component systems comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy," including rods, screws, and other hardware. This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide immobilization and stabilization of spinal segments. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of components (screws, rods, etc.) made of metal alloys, designed to be attached to the spine. This aligns with a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Performance Studies: The performance studies described are mechanical tests, which are relevant for evaluating the structural integrity and function of a surgical implant, not the diagnostic accuracy of an IVD.
In summary, the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are surgical implants used for spinal fixation, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
NKB, KWP, KWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments (T1-S2/Ilium), T8-L5
Indicated Patient Age Range
Skeletally mature patients, pediatric patients (adolescent idiopathic scoliosis)
Intended User / Care Setting
Surgeon, posterior spinal surgery
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 was conducted on the subject devices as listed below in Table 1: Mechanical Performance Testing
Table 1: Mechanical Performance Testing
| Subject Device | Mechanical Testing |
|---|---|
| Reduction Body | Dynamic Compression Bending per ASTM F1717-15 |
| Low Profile Offset | Justification based upon worst case Mono-Axial Lateral Offset construct |
| Mono-Axial Lateral Offset | Dynamic Compression Bending per ASTM F1717-15 |
| Front Loading, Top Loading & Axial Rod Connectors | Dynamic Compression Bending per ASTM F1717-15 |
| Anodized Straight and Pre-Lordosed titanium alloy (Ti-6AL-4V ELI) Lined Rods | Dynamic Compression Bending per ASTM F1717-15 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K153428), Spinal Fixation System (K080407)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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)
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.
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.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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 Information
Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214-937-2100
214-937-3322
jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch |
| Date Prepared: | April 28, 2017 |
| Name of Device
Trade Name / Proprietary
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 |
| 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:
-
- Addition of new Reduction Body
-
- Addition of new Low Profile Offset
-
- Modification of the Mono-Axial Lateral Offset
-
- Addition of new Front Loading and Axial Rod Connectors
5
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
-
- Modification to the Top Loading Rod Connector
-
- 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
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.
Intended Use / Indications for Use
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 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 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
6
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 ASTM |
| F1717-15 | |
| Low Profile Offset | Justification based upon worst case Mono-Axial |
| Lateral Offset construct | |
| Mono-Axial Lateral Offset | Dynamic Compression Bending per ASTM |
| F1717-15 | |
| Front Loading, Top Loading & Axial Rod | |
| Connectors | Dynamic Compression Bending per ASTM |
| F1717-15 | |
| Anodized Straight and Pre-Lordosed | |
| titanium alloy (Ti-6AL-4V ELI) Lined Rods | Dynamic Compression Bending per ASTM |
| F1717-15 |
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.