(65 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a spinal fixation system intended to be used as an adjunct to fusion for various spinal conditions, indicating its role in treating these conditions.
No
Explanation: The device, the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System, is described as a surgical implant for spinal fixation, used as an adjunct to fusion. Its intended use includes treating conditions like degenerative disc disease, spondylolisthesis, and trauma by providing mechanical support and stability. It is not designed to diagnose diseases or conditions.
No
The device description explicitly states it is comprised of physical components made of titanium alloy or cobalt chrome alloy, such as rods, screws, and hooks, which are implanted into the body. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are "temporary, multiple component systems comprised of a variety of non-sterile, single use components... that allow the surgeon to build a spinal implant construct." These components are "attached to the vertebral body and ilium by means of screw or hook fixation."
- Intended Use: The intended use describes the device's application in surgical procedures for spinal fixation, addressing various spinal conditions.
The device is a surgical implant used directly on the patient's body, not for testing samples outside the body.
N/A
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) spondvlolisthesis.
- 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, KWP, MNH, MNI
Device Description
The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488, K130932) 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, hooks, 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
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 was conducted on the subject devices per ASTM F1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants" which included insertion torque mechanical testing, flexion-bending tests, static and dynamic compression bending and static torsion tests. No mechanical testing was performed for modified bone screws that only entailed increasing thread surface area at the distal tip with no changes to structural integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2016
Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K153428
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, MNH, MNI, KWP Dated: November 24, 2015 Received: November 25, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 yours,
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) K153428
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 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 pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to freat adolescent idiopathic scoliosis. The Firebird Spinal Fixation 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.
3
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4
510(k) SUMMARY
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
| 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 | |
| jackigeren@orthofix.com | |
| Registration Number: | 3008524126 |
| Contact Person: | Jacki Geren, Requlatory Affairs Specialist, II |
| Date Prepared: | November 24, 2015 |
| Name of Device | |
| Trade Name / Proprietary | |
| Name: | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
| Common Name: | Spinal Fixation System |
| Product Code: | NKB; OSH; KWP; MNH; MNI |
| Requlatory Classification: | Class III Pre amendment Device, 21 CFR §888.3070 - Pedicle |
| screw spinal system | |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate: | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
| (K130932) | |
| Additional Predicates: | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
| (K151488) | |
| Spinal Fixation System (K023498) |
Reason for 510(k) Submission:
Orthofix is submitting this Traditional 510(k) premarket notification for the below to the previously cleared Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488):
- JANUS Midline Fixation Screw (Cannulated and Non-Cannulated) ●
- Phoenix CDX MIS Spinal Fixation System - Modular Mono-Axial Body with Extended Tab
- Firebird NXG Spinal Fixation System -●
5
- Set Screw o
- o Multi-Axial Screw Top-Loading Body
- Low Profile Off-Set Body O
- Modified Firebird Spinal Fixation System Bone Screws ●
Device Description
The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488, K130932) 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, hooks, 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 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) spondvlolisthesis.
- 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 the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the subject devices presented in Table 1: Technological Characteristics are similar to the predicate devices in terms of design, dimensions, intended
6
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 (K130932) which would adversely affect the use of the product.
| | Subject Device:
Firebird Spinal Fixation
System/Phoenix MIS Spinal
Fixation System
JANUS Midline Fixation Screw
Phoenix CDX MIS Spinal
Fixation System
Firebird NXG Spinal Fixation
System | Primary Predicate Device: Firebird
Spinal Fixation System/Phoenix
MIS Spinal Fixation System
(K130932) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name | Firebird Spinal Fixation
System/Phoenix MIS Spinal
Fixation System
JANUS Midline Fixation Bone
Screw
Phoenix CDX MIS Spinal
Fixation System
Firebird NXG Spinal Fixation
System | Firebird Spinal Fixation
System/Phoenix MIS Spinal Fixation
System (K130932) |
| Method of
Fixation | Non-Cervical Fixation | Non-Cervical Fixation |
| Implantation | 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 |
| Material | Titanium alloy (Ti-6AL-4V ELI) | Titanium Alloy (Ti-6AL-4V ELI) |
Table 1: Technological Characteristics
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 2: Mechanical Performance Testing
| Table 2: Mechanical Performance Testing | |
|---|---|
| ----------------------------------------- | -- |
| Subject Device | Mechanical Testing |
|---|---|
| JANUS Midline Fixation | |
| Screw (Cannulated and | |
| Non-Cannulated) | Insertion Torque Mechanical Testing (Non- |
| Cannulated) | |
| Phoenix CDX MIS Spinal | |
| Fixation System Modular | |
| Mono-Axial Body with | |
| Extended Tab | Flexion-Bending tests per ASTM F1798-13 "Standard Test |
| Method for Evaluating the Static and Fatigue Properties of | |
| Interconnection Mechanisms and Subassemblies Used in | |
| Spinal Arthrodesis Implants". | |
| Firebird NXG Spinal | Static and Dynamic Compression Bending and Static Torsion |
| tests per ASTM F1717-14 "Standard Test Mehods for | |
| Spinal Implant Constructs in a Vertebrectomy Model." |
7
| Fixation System:
• Set Screw
• Multi-Axial Screw Top-
Loading Body
• Low Profile Offset Body
and Set Screw | Static Torsion tests per ASTM F1717-14 "Standard
Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model." |
|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modified Firebird Spinal
Fixation System/Phoenix
MIS Spinal Fixation System
Bone Screws | No mechanical testing performed. Modification entailed
increasing thread surface area at the distal tip of the
bone screw with no changes to the structural integrity
of the main threaded section or neck of the bone
screw. |
Basis of Substantial Equivalence
The subject devices will utilize the same intended use, indications for use, and will have the same technological characteristics, design, materials and principles of operation as to the predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K130932).