(55 days)
Not Found
No
The device description explicitly states that the system does not contain software/firmware or electrical equipment, and there are no mentions of AI, DNN, or ML.
Yes
The device is described as a system for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, which directly indicates a therapeutic purpose.
No
Explanation: The X-spine Cortical Bone Screw System is described as implants (pedicle screws, rods, cross connectors) used for stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly states, "The system does not contain software/firmware or electrical equipment."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The X-spine Cortical Bone Screw System is described as consisting of pedicle screws, rods, cross connectors, and associated instruments. These are physical implants and tools used in surgical procedures.
- Intended Use: The intended use is for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant system used to treat spinal conditions, not a device for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
· Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
- · Spondylolisthesis
- · Trauma (i.e. fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e. scoliosis, kyphosis)
- · Spinal tumor
- · Pseudoarthrosis, and/or
- · Failed previous fusion
Product codes
NKB
Device Description
The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances.
The system does not contain software/firmware or electrical equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral 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
To aid in determining mechanical basis for substantial equivalence the X-spine Cortical Bone Screw System was subjected to the following testing per FDA guidance and recommendations:
- . ASTM F1717 – Static and dynamic axial compression bending testing
- ASTM F1717 - Static torsion testing
The results of these studies show that the subject device meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 15, 2018
X-spine Systems, Inc. Ms. Charlene Brumbaugh Regulatory Affairs Manager 664 Cruiser Lane Belgrade, Montana 59714
Re: K180153
Trade/Device Name: X-spine Cortical Bone Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 18, 2018 Received: January 19, 2018
Dear Ms. Brumbaugh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180153
Device Name
X-spine Cortical Bone Screw System
Indications for Use (Describe)
The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
· Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
- · Spondylolisthesis
- · Trauma (i.e. fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e. scoliosis, kyphosis)
- · Spinal tumor
- · Pseudoarthrosis, and/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) |
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510(K) SUMMARY (21 CFR 807.92)
X-spinesM Cortical Bone Screw System
| I. | SUBMITTER/MANUFACTURER: | X-spine Systems, Inc.
A Division of Xtant Medical Inc.
Corporate Office
664 Cruiser Lane
Belgrade, MT 59714
Telephone (406) 388-0480, ext. 1128 |
|------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: | 3005031160 |
| | Official Contact for 510k: | Charlene Brumbaugh
Regulatory Affairs Manager
Email: cbrumbaugh@Xtantmedical.com
Telephone (937) 847-8400, ext. 2192 |
| II. | DATE PREPARED: | March 15, 2018 |
| III. | OWNER/OPERATOR: | Xtant Medical Inc.
604 Cruiser Lane
Belgrade, MT 59714 |
| | Owner/Operator Number: | 10028385 |
| | Official Correspondent: | Stephen Smith, Vice President
Regulatory Assurance/ Quality Assurance
Xtant Medical, Inc.
Telephone (406) 388-0480, ext. 1106 |
| IV. | DEVICE | |
| | Trade/Proprietary Name:
Device Common Name:
Regulation Number:
Product Code: | X-spineSM Cortical Bone Screw System
Orthosis, Pedicle Screw Fixation
21 CFR §888.3070
NKB - thoracolumbosacral pedicle screw system |
| | Regulatory Class:
Review Panel: | Class II
Orthopedic |
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V. PURPOSE OF THE SUBMISSION
The purpose for this submission is to submit a new medical device for review.
VI. PREDICATE DEVICES
Primary Predicate:
- X-spine Pedicle Screw System (K152132) [Fortex®] ●
Additional Predicates:
- Arsenal Spinal Fixation System (K152968) [Alphatec Spine, Inc.]
- . Xia 4.5 Spinal System (K050461) [Stryker Spine]
VII. INDICATIONS FOR USE
The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:
- . Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- . Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
- Spondylolisthesis ●
- Trauma (i.e. fracture or dislocation) ●
- Spinal stenosis
- Deformities or curvatures (i.e. scoliosis, kyphosis)
- . Spinal tumor
- . Pseudoarthrosis, and/or
- Failed previous fusion
VIII. DEVICE DESCRIPTION
The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances.
The system does not contain software/firmware or electrical equipment.
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IX. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technological principle for both the subject and predicate devices is temporary posterior, non-cervical pedicle spinal fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients, as an adjunct to spinal fixation.
As was established in this submission, the subject device, X-spine™ Cortical Bone Screw System, is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same or similar technological and functional characteristics as its primary predicate device and additional predicate devices, through comparison in areas including design, intended use, material composition, and technological and functional characteristics.
- FDA Product Code: NKB
- Implants use the same materials: titanium alloy and/or cobalt chrome alloy.
- Multiple lengths of pedicle screws and rods to account for variations in patient anatomy.
- Equivalent Intended Uses.
- Same anatomical region.
- Same surgical approach.
- Mechanical Performance.
PERFORMANCE DATA X.
To aid in determining mechanical basis for substantial equivalence the X-spine Cortical Bone Screw System was subjected to the following testing per FDA guidance and recommendations:
- . ASTM F1717 – Static and dynamic axial compression bending testing
- ASTM F1717 - Static torsion testing
The results of these studies show that the subject device meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
XI. CONCLUSION
Based on assessment of the indications for use, technological characteristics, performance data, and comparison to the primary predicate device and additional predicate devices, the subject device, X-spine… Cortical Bone Screw System has been shown to be substantially equivalent to legally marketed predicate devices.