(35 days)
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are 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. 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
When used for fixation to the illum, 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 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 System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow a 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 and 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, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System and 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System) and primarily focuses on proving substantial equivalence to a predicate device, not on presenting novel clinical study results for acceptance criteria in the typical sense of a new AI/diagnostic device.
The "acceptance criteria" here are mechanical performance standards for the spinal fixation system components and are met by demonstrating the new component (HA Coated Bone Screws) performs equivalently or better than the predicate device. The "study" is a series of non-clinical mechanical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test / FDA Guidance) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Substantially Equivalent Performance: |
| ASTM F1717-12 (Static Torsion Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| ASTM F1717-12 (Static Axial Compression Bending Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| ASTM F1717-12 (Dynamic Axial Compression Bending Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| ASTM F1798-97(2008) (Implant Axial Rod Gripping Test) | "No change from the predicate device geometry." The addition of HA coating has "no effect on the mechanical testing previously conducted" and "will not generate a new worst case and will not impede the mechanical function of the bone screw." |
| Insertion Torque Testing – Test Method for Driving Torque of Medical Bone Screw (Proprietary Method) | "Test results demonstrated that the subject HA (Hydroxyapatite) Coated Bone Screws do not introduce any safety or efficacy concerns and is substantially equivalent to the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-tapping Cannulated Bone Screws (K130932)." Performance was specifically characterized for any difference in insertion torque, and the conclusion was that there were no safety or efficacy concerns. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for the mechanical tests. It refers to "the subject Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA (Hydroxyapatite) Coated Bone Screws" and "predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-Tapping Cannulated Bone Screws." In mechanical testing, samples are typically specific numbers of manufactured devices.
- Data Provenance: The data comes from non-clinical performance testing conducted by the manufacturer, Orthofix, Incorporated. It is not patient or clinical data, so country of origin or retrospective/prospective does not apply in the typical sense. It's laboratory test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. For mechanical tests, the "ground truth" is defined by the physical properties and performance characteristics measured against industry standards (ASTM). The determination of "substantial equivalence" is made by the FDA based on the submitted test results and comparison to predicate devices, not by clinical experts establishing ground truth on a test set.
4. Adjudication method for the test set
- This is not applicable. Mechanical testing does not involve adjudication of expert opinions. The test results are quantitative measurements compared against predefined standards or predicate device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. This submission is for a spinal fixation system, not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- The "ground truth" for the mechanical tests is defined by the industry standard specifications (ASTM F1717-12, ASTM F1798-97(2008)) for spinal implant systems and the measured performance characteristics of the predicate device (K130932). The goal was to show that the new HA-coated screws perform at least as well as the established, FDA-cleared predicate device against these objective mechanical benchmarks.
8. The sample size for the training set
- This is not applicable. No training set was used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- This is not applicable. No training set was used.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2015
Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K151488
Trade/Device Name: Firebird Spinal Fixation System/Phoenix MIS 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: June 1, 2015 Received: June 2, 2015
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
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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
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Indications for Use
510(k) Number (if known)
K151488
Device Name
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
Indications for Use (Describe)
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are 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. 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
When used for fixation to the illum, 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 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 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, bold letters. A small registered trademark symbol is located to the right of the word "ORTHOFIX".
6.0 510(k) Summary
| Name:Address: | Orthofix Inc.3451 Plano ParkwayLewisville, Texas 75056 |
|---|---|
| Telephone Number:Fax Number:Email: | 214-937-2000214-937-3322jackigeren@orthofix.com |
| Registration Number: | 3008524126 |
| Contact Person: | Jacki GerenRegulatory Affairs Specialist, II |
| Date Prepared: | June 1, 2015 |
| Name of Device | |
| Trade Name/ProprietaryName: | Firebird Spinal Fixation System / Phoenix MIS Spinal FixationSystem |
| Common Name: | Spinal Fixation System |
| Product Code: | NKB; OSH; KWP; MNH; MNI |
| Regulatory Classification: | Class III Pre amendment Device, 21 CFR §888.3070 – Pediclescrew spinal system - *Class III Summary and CertificationRequired |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Orthofix Inc. Firebird Spinal Fixation System/Phoenix MISSpinal Fixation System - K130932 |
| Reference Devices: | Pioneer Surgical Technology – Quantum Spinal System(including MIS) HA Coated Pedicle Screws (Non-Cannulatedand Cannulated) – K101790Globus Medical Inc. – CREO Stabilization System – K124058 |
| Reason for 510(k) Submission: | Addition of HA (Hydroxyapatite) Coated Bone Screws |
| Device Description: | The Firebird Spinal Fixation System and Phoenix MIS SpinalFixation System are temporary, multiple component systemscomprised of a variety of non-sterile and sterile, single usecomponents, made of titanium alloy or cobalt chrome alloy, that |
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Image /page/5/Picture/1 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, bold letters. A registered trademark symbol is to the right of the word "ORTHOFIX".
geon 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 and 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, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System and 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 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: 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
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 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.
Summary of Technological Characteristics of the Device Compared to the Selected Predicate Device
| Subject Device: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA | Primary Predicate Device: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
|---|---|
| --------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
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Image /page/6/Picture/1 description: The image contains the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in bold, black letters. A registered trademark symbol is present to the right of the word "ORTHOFIX".
| (Hydroxyapatite) Coated BoneScrews | (K130932) | |
|---|---|---|
| Device Name | Firebird Spinal FixationSystem/Phoenix MIS SpinalFixation System | Firebird Spinal FixationSystem/Phoenix MIS Spinal FixationSystem (K130932) |
| Method ofFixation | Non-Cervical Fixation | Non-Cervical Fixation |
| Implantation | Posterior Approach | Posterior Approach |
| Design | This system allows a surgeon tobuild a spinal implant construct | This system allows a surgeon to builda spinal implant construct |
| Material | Titanium alloy (Ti-6AL-4V ELI)and HA (Hydroxyapatite)Coating | Titanium Alloy (Ti-6AL-4V ELI) |
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
| Characteristics | Standard / Test / FDA Guidance |
|---|---|
| Firebird Spinal Fixation System/PhoenixMIS Spinal Fixation System CannulatedImplant Static Torsion Test | ASTM F1717-12 No change from the predicatedevice geometry |
| Firebird Spinal Fixation System/PhoenixMIS Spinal Fixation System CannulatedImplant Static Axial Compression BendingTest | ASTM F1717-12 No change from the predicatedevice geometry |
| Firebird Spinal Fixation System/PhoenixMIS Spinal Fixation System CannulatedImplant Dynamic Axial CompressionBending Test | ASTM F1717-12 No change from the predicatedevice geometry |
| Firebird Spinal Fixation System/PhoenixMIS Spinal Fixation System Implant AxialRod Gripping Test | ASTM F1798-97(2008) No change from thepredicate device geometry |
| Firebird Spinal Fixation System/PhoenixMIS Spinal Fixation System HA(Hydroxyapatite) Coated Bone ScrewsImplant Insertion Torque Testing | Insertion Torque Testing – Test Method forDriving Torque of Medical Bone Screw |
Performance Data Summary
When assessing the performance of the subject Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA (Hydroxyapatite) Coated Bone Screws are substantially equivalent in design, configuration, and function as the predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-Tapping Cannulated Bone Screws (K130932). The addition of the HA (Hydroxyapatite) coating has no effect on the mechanical testing previously conducted on the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-Tapping Cannulated Bone Screws (K130932) as the subject screw and predicate screw both have the same dimensions. The addition of the HA coating to the threaded region of the bone screw will not generate a new worst case and will not impede the mechanical function of the bone screw.
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Image /page/7/Picture/1 description: The image contains the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, block letters. A registered trademark symbol is located to the right of the word "ORTHOFIX".
Supplemental performance testing was conducted to characterize any difference in insertion torque of the subject HA (Hydroxyapatite) Coated Bone Screws may generate when compared to the predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-tapping Cannulated Bone Screws (K130932). Test results demonstrated that the subject HA
(Hydroxyapatite) Coated Bone Screws do not introduce any pgy "safety or efficacy concerns and is substantially equivalent to the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-tapping Cannulated Bone Screws (K130932).
Basis of Substantial Equivalence
The subject Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA (Hydroxyapatite) Coated Bone Screws are substantially equivalent in design, configuration, function, and indications for use to the Orthofix Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K130932).
§ 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.