(30 days)
Not Found
No
The document describes various spinal implant systems (screws, rods, plates, spacers) and their intended uses and materials. There is no mention of any software, algorithms, image processing, or AI/ML capabilities. The focus is entirely on the mechanical components and their application in spinal fusion and stabilization.
Yes
The device is described as an "Inertia™ Pedicle Screw System" along with other spinal fixation systems, all of which are indicated to "provide immobilization of spinal segments as an adjunct to fusion" and for "treatment of" various spinal instabilities, deformities, and diseases. This clearly aligns with the definition of a therapeutic device.
No
The document describes several spinal implant systems (Inertia™ Pedicle Screw System, HONOUR™ Spacer System, Facet Fixx™ System, Struxxure™ System) which are physical devices designed to provide immobilization and stabilization to the spine as an adjunct to fusion or for replacement. They are used in treatment and are not described as performing any diagnostic functions like analyzing data or identifying conditions.
No
The device description clearly outlines physical implants made from materials like titanium alloy, CP Titanium, PEEK, and tantalum, which are hardware components. The intended use also describes surgical procedures involving these implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the devices are implants made of materials like titanium alloy, CP Titanium, PEEK, and tantalum. These are physical devices intended for surgical implantation.
- Intended Use: The intended use describes the devices as providing immobilization, fusion, and replacement of spinal segments and vertebral bodies. These are surgical procedures, not diagnostic tests performed on samples.
The text describes a system of surgical implants used to treat spinal conditions, which falls under the category of medical devices, but not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Inertia™ Pedicle Screw System is intended to provide immobilization 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a cervical intervertebral fusion devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ded for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion devices the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar soine, from L2-S1. in skeletally mature patients who have had six months of -nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for Use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).
When used as a vertebral body replacement devices are indicated for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues. and to restore the height of a collapsed vertebral body. The device is intended for use with autograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).
The Facet Fixx System is intended to spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are interior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the spinous process. through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
The Facet Fixx System is intended for bilation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
- Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
- Degenerative disease of the facets with instability
- Trauma (i.e. fracture or dislocation)
- Spondylolisthesis
- Spondylolysis
- Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity
The Struxxure™ System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), turnor, pseudarthrosis or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP, MQP, ODP, MAX, MRW, KWQ
Device Description
This submission modifies the sterilization and packaging state of the Nexxt Spine spinal systems implants. The Inertia Honour™ , Facet Fixx™ and Struxxure ™ implants will be optionally available as sterile.
The Inertia Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.
The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column: The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.
The Facet Fixx™ System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.
Struxxure TM consists of plates and screws in a variety of sizes. Plates from 1to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.
Nexxt Spine spinal systems implants are manufactured from a variety of medical grade materials including titanium alloy (Ti-6Al-4V ELI) per ASTM F136, CP Titanium (Grade 2 or 4) per ASTM F67, Zeniva® ZA-500 polyetheretherketone per ASTM F-2026 or tantalum per ASTM F-560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
honour devices: cervical spine, from C2-T1; lumbar spine, from L2-S1; thoracolumbar spine (T1-L5)
Inertia Pedicle Screw System: thoracic, lumbar, and sacral spine (T1 to S2)
Facet Fixx System: C2 to S1 inclusive
Struxxure System: cervical spine
Indicated Patient Age Range
skeletally mature patients
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 is not provided in this submission.
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.
K090984, K101278, K132412, K120345, K131417, K133475
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
JUN 2 6 2014 - 1 1 - K141376 - Page 1 of 3
510(k) Summary
Date: Sponsor: 21 May 2014 Nexxt Spine 14425 Bergen Blvd, Suite B Noblesville, IN 46060 Office: 317.436.7801 Fax: 317.245.2518
Eric Lintula, Director of Engineering and Regulatory Affairs
Inertia , Honour TM , Facet Fixx TM , Inertia ™ MIS, Struxxure™
Pedicle screw system, anterior cervical system, vertebral body replacement system, interbody fusion system and facet screw system
Inertia and Inertia™ MIS
888.3050, Spinal interlaminal fixation orthosis, KWP, Class II
888.3070, Pedicle screw spinal system, MNI & MNH; Class II Honour ™.
888.3060; Spinal intervertebral body fixation orthosis, MQP, Class II 888:3080. Intervertebral body fusion device, ODP & MAX, Class II Facet Fixx™
Unclassified, System, facet screw spinal device, MRW Struxxure TM
888.3060, Spinal intervertebral body fixation orthosis, KWQ, Class II
This submission modifies the sterilization and packaging state of the Nexxt Spine spinal systems implants. The Inertia Honour™ , Facet Fixx™ and Struxxure ™ implants will be optionally available as sterile.
The Inertia Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.
The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column: The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.
The Facet Fixx™ System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.
Struxxure TM consists of plates and screws in a variety of sizes. Plates from 1to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.
The Intended Use for each cleared spinal system is unchanged.
The Inertia Pedicle Screw System is 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)
Contact Person: Trade Names: .
Common Names:
Device Classification, Classification Regulations, Names & Product Codes:
Submission Purpose:
Device Descriptions:
Intended Use:
1
When used as a cervical intervertebral fusion device, the HONOURT devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia" Pedicle Screw System).
When used as a vertebral body replacement device; the HONOUR™ devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve antenor decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia "Pedicle Screw. System).
The Facet Fixx™ System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle:
The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to $1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
- Degenerative disease of the facets with instability
- Trauma (i.e. fracture or dislocation)
- Spondylolisthesis
- · Spondylolysis
- Pseudarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity
2
· K141376 - Page 3 of 3
The Struxxure™ System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Nexxt Spine spinal systems implants are manufactured from a variety of medical grade materials including titanium alloy (Ti-6Al-4V ELI) per ASTM F136, CP Titanium (Grade 2 or 4) per ASTM F67, Zeniva® ZA-500 polyetheretherketone per ASTM F-2026 or tantalum per ASTM F-560.
Inertia Pedicle Screw System, Nexxt Spine, K090984, K101278 & K132412 Honour™ Spacer System, Nexxt Spine, K120345
Facet Fixx™, Nexxt Spine, K131417
Struxxure™ Anterior Cervical Plate and Screws, Nexxt Spine, K133475
Performance data is not provided in this submission.
the same intended use (as described above).
Each spinal system implant possesses the identical technological characteristics as its respective predicate implant. These include:
- · basic design,
- material.
- mode of operation,
- sizing and
implants have
- anatomic location.
Therefore the fundamental scientific technology of each Nexxt Spine spinal system implant is the same as the previously cleared Nexxt Spine spinal system implant.
In comparison to the predicate devices, the Nexxt Spine spinal system
Conclusion:
Conclusion:
the same technological characteristics (as described above) Therefore the Nexxt Spine spinal system implants can be found substantially equivalent to the predicate Nexxt Spine spinal system implants.
Materials:
Predicate Devices:
. . .
. .
Performance Data: Technological
Characteristics:
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the wings and body of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
Nexxt Spine, LLC % Karen E. Warden, Ph.D. BackRoads Consulting. Incorporated P.O. Box 566 Chesterland, Ohio 44026
Re: K141376
Trade/Device Name: Inertia® pedicle screw system, Inertia™ MIS pedicle screw system, Honour interbody fusion system, Facet Fixx facet screw system, and Struxxure anterior cervical system
Regulation Number: 21 CFR 888.3070
Regulation Name: Pedicle screw spinal system
Regulatory Class: Class II
Product Code: MNH, MNI, KWP, MQP, ODP, MAX, MRW, KWQ
Dated: May 21, 2014
Received: May 28, 2014
Dear Dr. Warden:
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 (reporting of medical
4
Page 2 - Karen E. Warden, Ph.D.
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known) K141376
Device Name
Inertial® and Inertia™ MIS pedicle screw systems
Indications for Use (Describe)
The Inettia™ Pedicle Screw System is intended to provide immobilization 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis),
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
الـ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Zane W. Wyatt
Division of Orthopedic Devices
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
6
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.
510(k) Number (if known) K141376
Device Name HONOURTM interbody fusion system
Indications for Use (Describe)
When used as a cervical intervertebral fusion devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ded for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion devices the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar soine, from L2-S1. in skeletally mature patients who have had six months of -nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for Use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).
When used as a vertebral body replacement devices are indicated for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues. and to restore the height of a collapsed vertebral body. The device is intended for use with autograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
7
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510{k) Number (if known) K141376
Device Name Facet FixxTM facet screw system
Indications for Use (Describe)
The Facet Fixx System is intended to spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are interior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the spinous process. through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
The Facet Fixx System is intended for bilation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
· Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
- · Degenerative disease of the facets with instability
- · Trauma (i.e. fracture or dislocation)
- · Spondylolisthesis
- · Spondylolysis
· Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Division of Orthopedic Devices
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."
9
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Number (if known) K141376
Device Name
Struxxure™ anterior cervical system
Indications for Use (Describe)
The Struxxure™ System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), turnor, pseudarthrosis or failed previous fusion.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Zane Wallyatt Division of Offhopedic Devices
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."
FORM FDA 3881 (1/14)