(61 days)
No
The summary describes a mechanical pedicle screw system, navigated instruments that work with a separate navigation system, and bone cement. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is mentioned as a separate device (Medtronic StealthStation® Navigation System), and while navigation systems can sometimes incorporate AI/ML for image processing or planning, this summary does not indicate that the CarboClear® X Navigated Instruments specifically utilize AI/ML.
Yes.
The device is intended to restore the integrity of the spinal column and assist in spinal surgery for patients with advanced stage tumors, directly addressing a health condition.
No
The device is a pedicle screw system and associated instruments used to restore spinal column integrity and assist with screw placement during surgery. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components including implants (pedicle screws, rods, set screws), instruments, and bone cement. While it mentions use with a navigation system (which likely includes software), the core device being described is a hardware system for spinal surgery.
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 and Intended Use: The CarboClear® X Pedicle Screw System, its navigated instruments, and the associated bone cement are all physical devices intended for surgical implantation and assistance during spinal surgery. They are used to restore the integrity of the spinal column and aid in the placement of implants.
- No Mention of Biological Samples or Testing: The description and intended use do not involve the analysis of any biological samples from the patient.
Therefore, this device falls under the category of a surgical implant and associated instruments, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CarboClear® X Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
When used in conjunction with High V+® Bone Cement, the CarboClear® X Fenestrated Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes
NKB, OLO, PML
Device Description
CarboClear® X Pedicle Screw System: The CarboClear® X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The implants for minimally invasive surgical procedures include pedicle screws, rods, and a set screw (locking element). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. Implants may include tantalum markers. The implants are supplied sterile, and are intended for single use.
CarboClear® X Navigated Instruments: CarboClear® X Navigated Instruments are manually operated, instruments intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery.
CarboClear® X Fenestrated Screw System: The CarboClear® X Fenestrated Pedicle Screw System consists of cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near the screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body. The Screws are implanted with the components of the CarboClear® X Pedicle Screw System. The CarboClear® X Fenestrated Screw System is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the screws is encased within a thin titanium shell, and includes a small tantalum marker. The CarboClear® X Fenestrated Screw System is supplied sterile, and is intended for single use.
High V+® Bone Cement: Self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzovl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Thoracic and lumbar spine, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, spinal surgery
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)
Design validation evaluation, including engineering analyses and testing, was conducted to demonstrate that the CarboClear® X Pedicle Screw System is appropriate for its intended use, and is substantially equivalent to predicate devices, as applicable.
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.
K193423, K200596, K162912, K170937, K210716, K190526
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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July 3, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Carbofix Orthopedics Ltd. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim St. Herzeliya, 4672411 Israel
Re: K231280
Trade/Device Name: CarboClear® X Pedicle Screw System: CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, OLO, PML Dated: May 2, 2023 Received: May 3, 2023
Dear Yael Rubin:
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.
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
1
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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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/cdrh-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,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S". The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. The text is black and the background is white. There is a faded FDA logo in the background.
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
510(k) Number (if known) K231280
Device Name
CarboClear® X Pedicle Screw System
Indications for Use (Describe)
The CarboClear® X Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of 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) |
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
510(k) Number (if known) K231280
Device Name
CarboClear® X Navigated Instruments
Indications for Use (Describe)
CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClean® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
| 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
510(k) Number (if known) K231280
Device Name
CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
Indications for Use (Describe) CarboClear® X Fenestrated Pedicle Screw System
When used in conjunction with High V+ ® Bone Cement, the CarboClear® X Fenestrated Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
High V+® Bone Cement
When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
| 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."
5
510(K) Summary
CarboFix Orthopedics Ltd.
CarboClear® X Pedicle Screw System, CarboClear® X Navigated Instruments, CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement - Minimally Invasive Surgery (MIS) Approach
Applicant Name
CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
May 2023
Trade/Proprietary Name
-
- CarboClear® X Pedicle Screw System
-
- CarboClear® X Navigated Instruments
-
- CarboClear® X Fenestrated Pedicle Screw System (with High V+® Bone Cement)
Common Name
-
- Pedicle Screw System
-
- Stereotaxic Instrument
6
-
- Polymethylmethacrylate (PMMA) Bone Cement
Regulation Number and Device Class
-
- Class II; 21 CFR §888.3070
-
- Class II; 21 CFR §882.4560
-
- Class II; 21 CFR §888.3027
Product Code and Review Panel
-
- NKB; Thoracolumbosacral Pedicle Screw System; Orthopedic
-
- OLO; Stereotaxic Instrument; Orthopedic
-
- PML; Bone Cement, Posterior Screw Augmentation
Predicate Devices
Primary
-
- VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (icotec AG; K193423)
Additional
-
- VADER® Pedicle System, G21 Cement (icotec AG; K200596)
-
- CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments (CarboFix Orthopedics Ltd., K210716).
-
- CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement (CarboFix Orthopedics Ltd., K190526)
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CarboClear® X Pedicle Screw System
The CarboClear® X Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
CarboClear® X Navigated Instruments
CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
CarboClear® X Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® X Fenestrated Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
High V+® Bone Cement
When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement is intended to restore the integrity of the spinal column even in the absence
8
of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
System Description
CarboClear® X Pedicle Screw System
The CarboClear® X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.
The implants for minimally invasive surgical procedures include pedicle screws, rods, and a set screw (locking element). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. Implants may include tantalum markers.
The implants are supplied sterile, and are intended for single use.
CarboClear® X Navigated Instruments
CarboClear® X Navigated Instruments are manually operated, instruments intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery.
CarboClear® X Fenestrated Screw System
The CarboClear® X Fenestrated Pedicle Screw System consists of cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near the screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body. The Screws are implanted with the components of the CarboClear® X Pedicle Screw System.
9
The CarboClear® X Fenestrated Screw System is made of carbon fiberreinforced polyetheretherketone (CFR-PEEK). The threaded portion of the screws is encased within a thin titanium shell, and includes a small tantalum marker. The CarboClear® X Fenestrated Screw System is supplied sterile, and is intended for single use.
High V+® Bone Cement
Self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzovl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.
Purpose of Submission
Modification to the previously cleared CarboClear® X Pedicle Screw System and CarboClear® Navigated Instruments (K210716), as well as Fenestrated Screws with High V+® Bone Cement (K190526) to add the option of minimally invasive surgery approach.
Performance Data
Design validation evaluation, including engineering analyses and testing, was conducted to demonstrate that the CarboClear® X Pedicle Screw System is appropriate for its intended use, and is substantially equivalent to predicate devices, as applicable.
Substantial Equivalence
The CarboClear® X Pedicle Screw System and Navigated Instruments (including fenestrated screws), as intended for use in minimally invasive surgical approach, provide
10
for intended use, design, dimensions, materials, technological characteristics, and principles of operation which are substantially equivalent to those of the predicate devices, as applicable.
Conclusion
Based on the information provided in this 510(k) Premarket Notification, the subject CarboClear® X Pedicle Screw System, including fenestrated screws, and Navigated Instruments, as intended for use in minimally invasive surgical approach, are substantially equivalent to their predicate devices.