(29 days)
Not Found
No
The document describes a pedicle screw system, bone cement, and navigated instruments for spinal surgery. While the navigated instruments use imaging and a navigation system, there is no mention of AI or ML being used for image processing, analysis, or any other function of the device or its associated systems. The performance studies are mechanical tests, not related to AI/ML performance metrics.
Yes
The device is intended to restore the integrity of the spinal column and provide rigid immobilization and stabilization, which falls under the definition of therapeutic intervention.
No
The device, the CarboClear® Hybrid Pedicle Screw System, is intended to restore the integrity of the spinal column and provide immobilization and stabilization, serving as an implant for treatment rather than a tool for diagnosis.
No
The device description clearly outlines physical implants (pedicle screws, rods, trans-connectors, bone cement) and manually operated instruments. While it mentions navigated instruments used with a navigation system, the core device being described is a hardware system for spinal surgery, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The CarboClear® Hybrid Pedicle Screw System and its related components (navigated instruments, fenestrated screws, bone cement) are described as implants and instruments used during spinal surgery to stabilize and support the spine. They are physically implanted into the patient's body or used to assist in the surgical procedure.
- No Specimen Analysis: There is no mention of this device analyzing any biological specimens from the patient. Its function is mechanical support and surgical guidance.
Therefore, the CarboClear® Hybrid Pedicle Screw System and its associated components fall under the category of surgical implants and instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CarboClear® Hybrid Pedicle Screw System (Oncological)
The CarboClear® Hybrid 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® Hybrid Pedicle Screw System (DDD)
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
CarboClear® Hybrid Navigated Instruments
CarboClear® Hybrid Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Hybrid Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Hybrid 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® Hybrid Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® Hybrid 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® Hybrid 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 without cement, the CarboClear® Hybrid Fenestrated Pedicle Screws are intended: (a) 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.
(b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
High V+® Bone Cement
When used in conjunction with the CarboClear® Hybrid 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.
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.
When used without cement, the CarboClear® X Fenestrated Pedicle Screw System is intended: (a) 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.
(b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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.
Product codes
NKB, PML, OLO
Device Description
The CarboClear® Hybrid 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 CarboClear® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy locking element, and with CarboClear X CFR-PEEK rods and trans-connectors. The implants may include tantalum markers. CarboClear X titanium alloy rod is also offered.
The implants are supplied sterile, and are intended for single use.
The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.
The CarboClear® Hybrid Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® Hybrid pedicle screws, respectively, during spinal surgery.
The CarboClear® Hybrid Fenestrated Pedicle Screws and CarboClear® X Fenestrated Pedicle Screws are cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body in oncological patients.
These implants may also serve as traditional cannulated pedicle screws when used without bone cement.
The High V+ Bone Cement is a 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 benzoyl 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, or digitized landmarks of the anatomy.
Anatomical Site
thoracic and lumbar spine, lumbar and/or sacral segments (L2 to S1)
Indicated Patient Age Range
Patients should be skeletally mature
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)
Performance characteristics included static and dynamic compression bending tests according to ASTM F1717, as well as static flexion-extension test, axial gripping capacity test, and torsional gripping capacity test according to ASTM F1798. The results of the tests are comparable to those of the predicate devices, demonstrating substantially equivalent performance of the subject and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K210716, K231280, K233944, K190545, K193423, K200596, K222789, K082236, K170347, K153442
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.
0
April 25, 2024
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'Hoshlim Street Herzeliya, 4672411 Israel
Re: K240846
Trade/Device Name: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navieated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement: CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, PML, OLO Dated: March 27, 2024 Received: March 27, 2024
Dear Hila Wachsler-Avrahami:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
K240846 - Hila Wachsler-Avrahami
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.04.25
13:25:22 -04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
CarboClear® Hybrid Pedicle Screw System;
CarboClear® Hybrid Navigated Instruments;
CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement;
CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
Indications for Use (Describe)
CarboClear® Hybrid Pedicle Screw System (Oncological)
The CarboClear® Hybrid 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® Hybrid Pedicle Screw System (DDD)
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
CarboClear® Hybrid Navigated Instruments
CarboClear® Hybrid Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Hybrid Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Hybrid 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® Hybrid Fenestrated Pedicle Screw System
When used in conjunction with High V+® Bone Cement, the CarboClear® Hybrid 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® Hybrid 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 without cement, the CarboClear® Hybrid Fenestrated Pedicle Screws are intended: (a) 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.
(b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to
3
Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
High V+® Bone Cement
When used in conjunction with the CarboClear® Hybrid 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.
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.
When used without cement, the CarboClear® X Fenestrated Pedicle Screw System is intended: (a) 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.
(b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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.
4
510(k) Summary
CarboFix Orthopedics Ltd.
CarboClear® Hybrid Pedicle Screw System, CarboClear® Hybrid Navigated Instruments, CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement, CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
APPLICANT NAME
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
CONTACT PERSON
Hila Wachsler-Avrahami CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
DATE PREPARED
March 27, 2024
TRADE/PROPRIETARY NAME
- CarboClear® Hybrid Pedicle Screw System 1.
-
- CarboClear® Hybrid Navigated Instruments
- CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+ Bone Cement 3.
-
- CarboClear® X Fenestrated Pedicle Screw System and High V+ Bone Cement
COMMON NAME
-
- Thoracolumbosacral Pedicle Screw System
-
- Stereotaxic Instrument
- Polymethylmethacrylate (PMMA) Bone Cement 3.
REGULATION NUMBER AND DEVICE CLASS
-
- Class II; 21 CFR §888.3070
-
- Class II; 21 CFR §882.4560
- Class II; 21 CFR §888.3027 3.
5
PRODUCT CODE, REGULATORY DESCRIPTION AND REVIEW PANEL
-
- NKB: Thoracolumbosacral Pedicle Screw System: Orthopedic
-
- OLO; Orthopedic Stereotaxic Instrument; Orthopedic
- PML; Bone Cement, Posterior Screw Augmentation 3.
PREDICATE DEVICES
Primary Predicate Device:
CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716, K231280, K233944).
Additional Predicate Devices:
-
- CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement (CarboFix Orthopedics Ltd.; K231280)
-
- CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more)
-
- CD HORIZON™ Fenestrated Screw Set (Medtronic Sofamor Danek; K170347)
-
- Medtronic Navigated Manual Reusable Instruments (Medtronic Sofamor Danek; K153442 and more)
INDICATIONS FOR USE
CarboClear® Hybrid Pedicle Screw System
CarboClear® Hybrid Pedicle Screw System (Oncology)
The CarboClear® Hybrid 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® Hybrid Pedicle Screw System (DDD)
The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I
6
spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
CarboClear® Hybrid Navigated Instruments
CarboClear® Hybrid Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Hybrid Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Hybrid 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® Hybrid Fenestrated Pedicle Screws System
When used in conjunction with High V+® Bone Cement, the CarboClear® Hybrid 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® Hybrid 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 without cement, the CarboClear® Hybrid Fenestrated Pedicle Screws are intended:
- (a) 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.
- (b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of
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discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
High V+® Bone Cement
When used in conjunction with the CarboClear® Hybrid 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.
CarboClear® X Pedicle Screw System
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.
When used without cement, the CarboClear® X Fenestrated Pedicle Screws are intended:
- (a) 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.
- (b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and
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radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear® X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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.
SYSTEM DESCRIPTION
The CarboClear® Hybrid 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 CarboClear® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy locking element, and with CarboClear X CFR-PEEK rods and trans-connectors. The implants may include tantalum markers. CarboClear X titanium alloy rod is also offered.
The implants are supplied sterile, and are intended for single use.
The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.
The CarboClear® Hybrid Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® Hybrid pedicle screws, respectively, during spinal surgery.
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The CarboClear® Hybrid Fenestrated Pedicle Screws and CarboClear® X Fenestrated Pedicle Screws are cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body in oncological patients.
These implants may also serve as traditional cannulated pedicle screws when used without bone cement.
The High V+ Bone Cement is a 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 benzoyl 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 (K210716, K231280, K233944).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
- . The CarboClear® Hybrid Pedicle Screw System differs from the primary predicate in the screw tulip and locking element material.
- . The CarboClear® Hybrid pedicle screws are used with rods identical to the rods of the primary predicate.
- The subject CarboClear® X fenestrated screws and CarboClear® Hybrid fenestrated ● screws have the same indications as CarboFix fenestrated screws previously cleared in K190526 and K231280, when augmented with cement (High V+® Bone Cement). The subject fenestrated screws may also be used without cement, for the non-cement augmented indications stated in the Indications for Use section.
PERFORMANCE DATA
Performance characteristics included static and dynamic compression bending tests according to ASTM F1717, as well as static flexion-extension test, axial gripping capacity test, and torsional gripping capacity test according to ASTM F1798. The results of the tests
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are comparable to those of the predicate devices, demonstrating substantially equivalent performance of the subject and predicate devices.
SUBSTANTIAL EQUIVALENCE
The intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance of the CarboClear® Hybrid Pedicle Screw System (including the CarboClear® Hybrid Navigated Instruments and the CarboClear® Hybrid Fenestrated Pedicle Screw System (with High V+® Bone Cement)), and the CarboClear X Fenestrated Pedicle Screw System, are substantially equivalent to those of the predicate devices.
CONCLUSION
Based on the information provided in this 510(k) Premarket Notification, the CarboClear® Hybrid Pedicle Screw System, including the CarboClear® Hybrid Navigated Instruments and the CarboClear Hybrid Fenestrated Pedicle Screw System (with High V+® Bone Cement); and the CarboClear X Fenestrated Pedicle Screw System, are substantially equivalent to their predicate devices.