(57 days)
Not Found
No
The document describes mechanical spinal fixation systems and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "adjunct to fusion" intended to provide "immobilization of spinal segments" and "restore the integrity of the spinal column" for various medical conditions, which are therapeutic functions.
No
This device is a spinal implant system used for fusion and stabilization of the spine, not for diagnosing medical conditions. The "Intended Use / Indications for Use" section clearly describes its use in treating various spinal instabilities and deformities, none of which involve diagnosis.
No
The device description explicitly states that the systems are comprised of physical components made of titanium alloy or cobalt chrome alloy, such as rods, screws, hooks, and plates, which are implanted into the spine. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The descriptions and intended uses clearly state that these devices are implants used in surgical procedures to provide mechanical support, stabilization, and immobilization of the spine and sacroiliac joint. They are physical devices inserted into the body, not used to analyze biological samples.
The text describes surgical implants for spinal and sacroiliac fusion and fixation, which fall under a different category of medical devices than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Ascent POCT System
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Ascent POCT System is indicated for:
- Degenerative disc disease (defined as neck pain of discogenic origin with degeneration o of the disc confirmed by patient history and radiographic studies);
- Spondylolisthesis; .
- Fracture/dislocation;
- Spinal Stenosis; ●
- Atlanto-axial fracture with instability; ●
- Occipito-cervical dislocation' .
- Tumors'
- Revision of previous cervical spine surgery ●
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. Thev are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cables (titanium) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.
The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.
Centurion POCT System
The Centurion POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Centurion POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.
Spinal Fixation System (SFS)
The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients:
- Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; ●
- Who are receiving fusion using autogenous bone graft only; ●
- Who are having the device fixed or attached to the lumbar and sacral spine (L3 and ● below); and
- Who are having the device removed after the development of a solid fusion mass ●
The Spinal Fixation System (SFS), when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor: and f)
- g) Failed previous fusion (pseudarthrosis)
The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine. is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) Spondylolistheses;
- c) Spinal stenosis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis):
- e) Tumor:
- f) Pseudoarthrosis:
- q) Previous failed fusion; and
- h) Trauma (i.e., fracture or dislocation)
Firebird Spinal Fixation Svstems
The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal seqments 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:
- deqenerative 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 Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors.
When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems 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 Systems are intended to be used with autograft or allograft.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.
Connector System
-
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ - T3) The Connector System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
-
When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is 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:
-
deqenerative 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 posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.
FIREBIRD SI Fusion System
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac ioint disruptions, and intended for sacroiliac joint fusion for conditions including;
- sacroiliac joint disruptions, .
- degenerative sacroiliitis, .
- to auqment immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
Product codes (comma separated list FDA assigned to the subject device)
NKG, NKB, KWP, KWQ, OUR
Device Description
Ascent POCT System - The Ascent POCT System is a temporary, 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 Ascent POCT System consists of an assortment of rods, set screws, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws and songer cables. When used in the occipito-cervico-thoracic spine. the Ascent POCT System may be used from the Occiput to T3.
Centurion POCT System - The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium allov or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (titanium).
Spinal Fixation System (SFS) - The Spinal Fixation System (SFS) is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws, and hooks to the non-cervical spine. The Spinal Fixation System consists of an assortment of screws, hooks, rods, spacers, staples, washers, dominos, lateral offsets, and cross-connectors. The Spinal Fixation System (SFS) titanium implants are not compatible with components or metal from any other manufacturer's system. The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. When used as a nonpedicle anterolateral fixation system it may be used from levels T1 to S1. When used with pedicle screw fixation, the Spinal Fixation System (SFS) will be used at L5-S1, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below). When used as a posterior non-pedicle fixation system it may be used from levels T 1 to S1. When used as a non-pedicle anterolateral screw fixation system to the non-cervical spine, the staple and washer may be used from levels T6-L5.
Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation, Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws)- The Firebird Spinal Fixation Systems include 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 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 systems consist of an assortment of rods, multi-axial and mono-axial pedicle screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and sterile packed HA coated bone screws.
A subset of the systems' 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.
Connector System - The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System. Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.
FIREBIRD SI Fusion System - The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile and sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials.
FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends.
The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine-cervico-thoracic junction (Occiput - T3), craniocervical junction, cervical spine (C1 to C7), thoracic spine (T1 - T3), L5-S1 joint, lumbar and sacral spine (L3 and below), thoracic, lumbar and sacral spine, non-cervical spine, T1-S2/Ilium, T8-L5, sacroiliac joint
Indicated Patient Age Range
skeletally mature patients, pediatric patients, adolescent
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)
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
In accordance to the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Maqnetic Resonance (MR) Environment" the following testing was conducted:
- ASTM F2052-15 Standard test method for measurement of maqnetically induced ● displacement force on passive implants in the magnetic resonance environment
- ASTM F2213-17 Standard test method for measurement of magnetically induced ● torque on medical devices in the magnetic resonance environment
- ASTM F2119-07 Standard test method for evaluation of MR image artifacts from ● passive implants
- ASTM F2182-19E2 Standard test method for measurement of radio frequency induced . heating on or near passive implant during magnetic resonance imaging
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.
Ascent POCT System (K111183), Centurion POCT System (K201481), Spinal Fixation System (SFS) (K080407), Firebird Spinal Fixation Systems (K180179), Connector System (K172194), FIREBIRD SI Fusion System (K210667)
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
July 30, 2021
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Orthofix Inc. Jacki Koch Principle Regulatory Affairs 3451 Plano Parkway Lewisville, Texas 75056
Re: K211710
Trade/Device Name: Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, NKB, KWP, KWQ, OUR Dated: June 2, 2021 Received: June 3, 2021
Dear Jacki 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
Ascent POCT System
Indications for Use (Describe)
When intended to promote fusion of the cervical spine-cervico-thoracic junction (Occiput - T3), the Ascent POCT System is indicated for:
· Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis;
- · Fracture/dislocation;
- · Spinal Stenosis;
- · Atlanto-axial fracture with instability;
- · Occipito-cervical dislocation'
- · Tumors'
- · Revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI-T3). The hooks are intended to be placed from C1 to T3. The Songer Cables (titanum) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.
The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Centurion POCT System
Indications for Use (Describe)
The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Connector System
Indications for Use (Describe)
-
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ -T3) The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
-
When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is 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 posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.
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.
5
Indications for Use
510(k) Number (if known)
Device Name Spinal Fixation System (SFS)
Indications for Use (Describe)
The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients:
- · Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- · Who are receiving fusion using autogenous bone graft only;
- · Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- · Who are having the device removed after the development of a solid fusion mass.
The Spinal Fixation System (SFS), when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis:
e) Kyphosis;
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis)
The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) Spondylolistheses;
c) Spinal stenosis;
d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) Tumor:
f) Pseudoarthrosis;
g) Previous failed fusion; and
h) Trauma (i.e., fracture or dislocation)
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.
6
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180179
Device Name
Firebird Spinal Fixation Systems: Firebird System; Firebird Deformity Fixation System; Phoenix MIS Spinal Fixation System; Phoenix CDX MIS Spinal Fixation System; Firebird NXG Spinal Fixation System; JANUS Midline Fixation Screw; JANUS Fenestrated Screw
Indications for Use (Describe)
The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors.
When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediale screw fixation is limited to a posterior approach.
The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft.
The Phoenix MIS Fixation System when used with the Firebird Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.
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.
7
Indications for Use
510(k) Number (if known)
Device Name FIREBIRD SI Fusion System
Indications for Use (Describe)
The FIREBIRD System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including;
· sacroiliac joint disruptions,
· degenerative sacroiliitis,
· to augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
8
510(k) SUMMARY
Ascent POCT System Centurion POCT System Spinal Fixation System (SFS) Firebird Spinal Fixation Systems
which includes: Firebird System Firebird Deformitv System Firebird NXG Spinal Fixation System Phoenix Minimally Invasive Spinal Fixation System Phoenix CDX Minimally Invasive Spinal Fixation System JANUS Midline Fixation Screw JANUS Fenestrated Screw Connector System FIREBIRD SI Fusion System
510(k) Owner Information
| Name:
Address: | Orthofix US LLC
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, Principle Regulatory Affairs |
| Date Prepared: | June 2, 2021 |
Name of Device
Trade Name / Proprietary Name:
Ascent POCT System Centurion POCT System Spinal Fixation System (SFS) Firebird Spinal Fixation Systems
- Firebird Deformity Spinal Fixation System ●
- Phoenix MIS Spinal Fixation System
- Phoenix CDX MIS Spinal Fixation System
- JANUS Midline Fixation Screws
- Firebird NXG Spinal Fixation System ●
- o JANUS Fenestrated Screws
Connector System FIREBIRD SI Fusion System
Product Code(s):
| System Name | Product Codes |
|---|---|
| Ascent POCT System | KWP |
| Centurion POCT System | NKG, KWP |
| Spinal Fixation System (SFS) | NKB, KWQ, KWP |
| Firebird Spinal Fixation Systems | NKB |
| • Firebird System |
9
| • Firebird Deformity System | |
|---|---|
| • Firebird NXG Spinal Fixation | |
| System | |
| • Phoenix Minimally Invasive | |
| Spinal Fixation System | |
| • Phoenix CDX Minimally | |
| Invasive Spinal Fixation | |
| System | |
| • JANUS Midline Fixation | |
| Screw | |
| • JANUS Fenestrated Screw | |
| Connector System | NKG, NKB, KWP, KWQ |
| FIREBIRD SI Fusion System | OUR |
Classification Name(s)
| System Name | Classification Name |
|---|---|
| Ascent POCT System | Spinal Interlaminal Fixation Orthosis |
| Centurion POCT System | Posterior Cervical Screw System |
| Spinal Fixation System (SFS) | Thoracolumboscacral Pedicle Screw System |
| Firebird Spinal Fixation Systems | |
| Firebird System Firebird Deformity System Firebird NXG Spinal Fixation System Phoenix Minimally Invasive Spinal Fixation System Phoenix CDX Minimally Invasive Spinal Fixation System JANUS Midline Fixation Screw JANUS Fenestrated Screw | Thoracolumboscacral Pedicle Screw Systems |
| Connector System | Posterior Cervical Screw System |
| FIREBIRD SI Fusion System | Smooth or Threaded Metallic Bone Fixation Fastener |
Device Classification
| System Name | Regulation |
|---|---|
| Ascent POCT System | Class II per 21 CFR § 888.3050 |
| Centurion POCT System | Class II per 21 CFR § 888.3075 |
| Spinal Fixation System (SFS) | Class II per 21 CFR § 888.3070 |
| Firebird Spinal Fixation Systems Firebird System Firebird Deformity System Firebird NXG Spinal Fixation System Phoenix Minimally Invasive Spinal Fixation System Phoenix CDX Minimally Invasive Spinal Fixation System JANUS Midline Fixation Screw | Class II per 21 CFR § 888.3070 |
| JANUS Fenestrated Screw Connector System | Class II per 21 CFR § 888.3075 |
10
| FIREBIRD SI Fusion System | Class II per 21 CFR§ 888.3040 |
|---|---|
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Ascent POCT System (K111183) – Orthofix US LLC |
| Centurion POCT System (K201481) – Orthofix US LLC | |
| Spinal Fixation System (SFS) (K080407) – Orthofix US LLC | |
| Firebird Spinal Fixation Systems (K180179) – Orthofix US LLC | |
| • Firebird Deformity Spinal Fixation System | |
| • Phoenix MIS Spinal Fixation System | |
| • Phoenix CDX MIS Spinal Fixation System | |
| • JANUS Midline Fixation Screws | |
| • Firebird NXG Spinal Fixation System | |
| • JANUS Fenestrated Screws | |
| Connector System (K172194) – Orthofix US LLC | |
| FIREBIRD SI Fusion System (K210667) – Orthofix US LLC |
Reason for 510(k) Submission:
Orthofix is submitting this Special 510(k) premarket notification for the addition of MR Conditional labeling to the subject medical devices.
The subject addition of MR Conditional labeling does not change the design, intended use, materials, performance specifications or the indications for use as previously cleared.
Device Description
Ascent POCT System - The Ascent POCT System is a temporary, 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 Ascent POCT System consists of an assortment of rods, set screws, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws and songer cables. When used in the occipito-cervico-thoracic spine. the Ascent POCT System may be used from the Occiput to T3.
Centurion POCT System - The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium allov or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (titanium).
Spinal Fixation System (SFS) - The Spinal Fixation System (SFS) is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws, and hooks to the non-cervical spine. The Spinal Fixation System consists of an assortment of screws, hooks, rods, spacers, staples, washers, dominos, lateral offsets, and cross-connectors. The Spinal Fixation System (SFS) titanium implants are not compatible with components or metal from any other manufacturer's system. The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. When used as a nonpedicle anterolateral fixation system it may be used from levels T1 to S1. When used with pedicle screw fixation, the Spinal Fixation System (SFS) will be used at L5-S1, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below). When used as a posterior non-pedicle fixation system it may be used from levels T 1 to S1. When used as a non-pedicle anterolateral screw fixation system to the non-cervical spine, the staple and washer may be used from levels T6-L5.
Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation, Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws)- The Firebird Spinal Fixation Systems include temporary, multiple component systems comprised of a variety of non-
11
sterile and 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 systems consist of an assortment of rods, multi-axial and mono-axial pedicle screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and sterile packed HA coated bone screws.
A subset of the systems' 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.
Connector System - The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System. Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.
FIREBIRD SI Fusion System - The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile and sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials.
FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends.
The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.
Intended Use / Indications for Use
Ascent POCT System
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Ascent POCT System is indicated for:
- Degenerative disc disease (defined as neck pain of discogenic origin with degeneration o of the disc confirmed by patient history and radiographic studies);
- Spondylolisthesis; .
- Fracture/dislocation;
- Spinal Stenosis; ●
- Atlanto-axial fracture with instability; ●
- Occipito-cervical dislocation' .
- Tumors'
- Revision of previous cervical spine surgery ●
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. Thev are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be
12
placed from C1 to T3. The Songer Cables (titanium) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.
The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.
Centurion POCT System
The Centurion POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Centurion POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.
Spinal Fixation System (SFS)
The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients:
- Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; ●
- Who are receiving fusion using autogenous bone graft only; ●
- Who are having the device fixed or attached to the lumbar and sacral spine (L3 and ● below); and
- Who are having the device removed after the development of a solid fusion mass ●
The Spinal Fixation System (SFS), when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor: and f)
- g) Failed previous fusion (pseudarthrosis)
The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine. is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) Spondylolistheses;
- c) Spinal stenosis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis):
- e) Tumor:
- f) Pseudoarthrosis:
- q) Previous failed fusion; and
- h) Trauma (i.e., fracture or dislocation)
13
Firebird Spinal Fixation Svstems
The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal seqments 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:
- deqenerative 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 Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors.
When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems 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 Systems are intended to be used with autograft or allograft.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.
Connector System
-
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ - T3) The Connector System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
-
When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is 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:
14
- deqenerative 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 posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.
FIREBIRD SI Fusion System
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac ioint disruptions, and intended for sacroiliac joint fusion for conditions including;
- sacroiliac joint disruptions, .
- degenerative sacroiliitis, .
- to auqment immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The Technological Characteristics, design, dimensions, intended use, materials and performance characteristics of the subject devices are unchanged from their previous clearance. The purpose of this 510(k) submission is for the addition of MR Conditional to the device labeling.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
In accordance to the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Maqnetic Resonance (MR) Environment" the following testing was conducted:
- ASTM F2052-15 Standard test method for measurement of maqnetically induced ● displacement force on passive implants in the magnetic resonance environment
- ASTM F2213-17 Standard test method for measurement of magnetically induced ● torque on medical devices in the magnetic resonance environment
- ASTM F2119-07 Standard test method for evaluation of MR image artifacts from ● passive implants
- ASTM F2182-19E2 Standard test method for measurement of radio frequency induced . heating on or near passive implant during magnetic resonance imaging
Basis of Substantial Equivalence
As stated throughout this 510(k) notification, there are no modifications to the design, intended use, or indications for use. The purpose of this 510(k) notification is for the addition of MR Conditional labeling for the subject devices.
The subject devices are temporary. multiple component systems comprised of a variety of single use components, made of titanium alloy or cobalt chrome alloy. There have been no changes to the design, to the material, intended use or indications for use.
Therefore the subject devices are identical to themselves as previously cleared.
15
In accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," the following testing was conducted to determine that the subject devices met requirements necessary for MRI Conditional labeling:
- ASTM F2052-15 "Standard test method for measurement of maqnetically induced o displacement force on passive implants in the magnetic resonance environment"
- ASTM F2213-17 "Standard test method for measurement of maqnetically induced . torque on medical devices in the magnetic resonance environment"
- ASTM F2119-07 - "Standard test method for evaluation of MR image artifacts from passive implants"
- ASTM F2182-19E2 "Standard test method for measurement of radio frequency induced ● heating on or near passive implant during magnetic resonance imaging"
- . ASTM F2503 - "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment"