(56 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Pedicle Screw System" indicated for the treatment of various spinal instabilities and conditions as an adjunct to fusion. This directly implies a therapeutic use for treating medical conditions.
No
This device is a surgical implant system (pedicle screws, rods, and connectors) used for spinal fixation and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, and cross bar connectors, which are hardware implants.
No, 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the X-spine 30 Pedicle Screw System clearly indicate it is a surgical implant used for spinal fixation and fusion. It is physically implanted into the body to provide structural support and stability.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose a condition or provide information about a patient's health status based on those tests.
The X-spine 30 Pedicle Screw System is a surgical implant used in the treatment of specific spinal conditions.
N/A
Intended Use / Indications for Use
The X-spine 30 Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.
In addition, the X-spine®M Pedicle Screw System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal fixation 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 of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
The X-spine™ Pedicle Screw System consists of pedicle screws, rods, cross bar 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 components are manufactured from 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to sacrum); posterior, non-cervical (T1-S2/ilium) pedicle spinal
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)
Biocompatibility: Implants are made of titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F1537), both materials with a long history of use and proven biocompatibility, corrosion-resistance, and non-toxicity.
Mechanical Performance: Engineering evaluation showed that the performance of the system is unaffected by the modifications (lengthened screws) and raises no new concerns of safety or effectiveness, as there is no material change to the screw's proximal aspect, cup, set screw, locking mechanism, or manufacturing/finishing process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2015
X-spine Systems, Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K152132
Trade/Device Name: X-spinesM Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: July 30, 2015 Received: August 4, 2015
Dear Dr. Kirschman:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - David Kirschman, M.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name X-spinesM Pedicle Screw System
Indications for Use (Describe)
The X-spine 30 Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.
In addition, the X-spine®M Pedicle Screw System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal fixation 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 of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
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
X-spine™ Pedicle Screw System
| Submitter/Manufacturer: | X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342
Telephone (937) 847-8400
FAX (937) 847-8410
Email: dk@X-spine.com |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | David Kirschman, M.D.
Chief Medical Officer |
| Date Prepared: | July 30, 2015 |
| Establishment Registration Number: | 3005031160 |
| Owner/Operator Number: | 9063903 |
II. DEVICE NAME
| Trade/Proprietary Name: | X-spine Pedicle Screw System |
|---|---|
| Common Name: | Pedicle screw spinal system |
| Device Class: | Class II |
| Regulation Number: | 21 CFR §888.3070 |
| Product Codes/Classification Names: |
- ' MNI -- Orthosis, Spinal Pedicle Fixation – Pedicle screw spinal system
- MNH -- Orthosis, Spondylolisthesis Spinal Fixation Pedicle screw spinal ■ system
Note: Proprietary Names included in the X-spine™ Pedicle Screw System are:
- . Fortex• Pedicle Screw System
- . Xpress™ Minimally Invasive Pedicle Screw System
III. PREDICATE DEVICES
- . Primary Predicate: Lanx Spinal Fixation System [Silverton; Silverton-D] (K122145) This predicate has not been subject to a design related recall. O
- . Additional Predicate: Fortex Pedicle Screw System (K090224, K120832) [X-spine, Inc.] o This predicate has not been subject to a design related recall.
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IV. DEVICE DESCRIPTION
The X-spine™ Pedicle Screw System consists of pedicle screws, rods, cross bar 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 components are manufactured from 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.
V. INDICATION FOR USE
The X-spine™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.
In addition, the X-spinew Pedicle Screw System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal fixation 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological principle for both the subject and predicated devices is temporary posterior, non-cervical pedicle spinal fixation in order to provide immobilization of spinal segments in skeletally mature patients, including spinal fusion and including posterior, noncervical (T1-S2/ilium) pedicle spinal fixation.
Specific features of Comparison:
- The predicate device Lanx System includes longer pedicle screws and S2/ilium in their Intended Use statement.
- . X-spine proposes the addition of longer pedicle screws and the inclusion of S2/ilium in their Intended Use statement.
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At a high level, the subject device and the predicate devices (primary and additional) are based on the following same or equivalent technological elements:
- FDA Product Codes: MNI and MNH
- . Implants use the same materials: titanium alloy and/or cobalt chrome alloy.
- Multiple lengths of pedicle screws to account for variations in patient anatomy.
- . Rods offered in multiple lengths and configurations to account for variations in patient anatomy.
- Equivalent Intended uses.
- . Same anatomical region.
- Same surgical approach.
- Mechanical Performance.
- . Cross-connectors available in fixed and variable designs.
The addition of one more vertebra, S2/ilium, does not pose additional risk, as this same intended use has already been cleared for use in the labeling of the primary predicate device, Lanx Spinal Fixation System [Silverton; Silverton-D] (K122145).
The following minor technological difference of screw sizes exists between the subject and predicate devices. However, the basic range of sizes is equivalent, as shown in the table below.
| | X-spine Proposed
Longer Screws | Primary Predicate | Additional Predicate |
|--------------------|-------------------------------------------------|------------------------------------------|----------------------|
| | Lanx Pedicle Screws:,
Silverton, Silverton-D | Current X-spine Fortex
Pedicle Screws | |
| Diameter of screws | 6.5 mm to 8.25 mm | 4.5 mm to 8.5 mm | 4.75 mm to 8.25 mm |
| Length of screws | 60 mm to 100 mm | 25 mm to 100 mm | 30 mm to 55 mm |
Table 5-1: Range of Screw Sizes
X-spine does not propose adding longer screws for the smaller diameters of 4.75 and 5.5.
VII. PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility
Implants of the X-spine Pedicle Screw System are made of titanium alloy. The titanium alloy conforms to ASTM F136 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The titanium material has a long history of use as surgical implants and has been proven to be biocompatible, corrosion-resistant, and not toxic to the biologic environment.
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X-spine System rods are also available in an alternate material choice, cobalt chrome alloy. The cobalt chrome alloy conforms to ASTM F1537 – Standard Specification for Wrought Cobalt-28 Chromium-6Molybdenum Alloys for Surgical Implants. The cobalt chrome alloy material has a long history of use as surgical implants and has been proven to be biocompatible, corrosionresistant, and not toxic to the biologic environment.
The products are ultrasonically cleaned using a validated cleaning process.
All instrument pieces that contact patient anatomy are manufactured of medical-grade materials, with long history of use in the medical setting and have been proven to be biocompatible: (medical-grade stainless steel, medical-grade Radel® plastic). The tissue contact is in limitedexposure settings.
Mechanical Performance
A review of the proposed changes shows that a lengthening of the screw (extension of the distal portion of the screw shank) has no material change to the proximal aspect of the screw, no change to the screw cup, no change to the set screw, no change to the locking mechanism, and no change to the locking functionality. There is also no change to the manufacture or finishing process of the system components. Engineering evaluation of the proposed additions to the X-Spine Pedicle Screw System shows that the performance of the system is unaffected by the modifications and raises no new concerns of safety or effectiveness.
VIII. CONCLUSION
Based on a review of the information provided, X-spine finds that the X-spine Pedicle Screw System is substantially equivalent to the referenced predicate device systems.