(66 days)
Not Found
No
The summary describes a mechanical implant system and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a pedicle fixation system intended to provide "immobilization and stabilization of spinal segments as an adjunct to fusion" for various spinal conditions, indicating its use in treating medical conditions.
No
This device is a pedicle screw system, described as an implant intended for immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "implant device made from a titanium alloy" and includes "pedicle screws" and "instrumentation," indicating it is a hardware-based medical device.
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, tissue) to provide information about a person's health.
- Device Description: The provided text clearly describes the CapLOX II® / TowerLOX® MIS Pedicle Screw System as an implant device made from titanium alloy, intended for surgical implantation into the spine.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II® / TowerLOX® MIS Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The CapLOX II® / TowerLOX® MIS Pedicle 4.5mm Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. It is to be implanted from the posterior approach. The screws are currently available in diameters from 4.9-9.0mm and in lengths from 30-100mm. The line extension will include the addition of 4.5mm screws for the CapLOX II® /TowerLOX® MIS Pedicle Screw System in lengths of 30-55mm. Additional instrumentation will also be added to the system. Overall, the system includes pedicle screws, and the instrumentation in order to complete the procedure and implant construct when performed using minimally invasive surgical techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, fifth lumbar-first sacral, L5-S1 vertebra, L3 to the sacrum/ilium
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)
Engineering Analysis and Dynamic Compression Bending testing per ASTM F1717 were conducted to confirm that introduction of the 4.5mm pedicle screws perform equivalently to the predicate data and does not introduce a new "worst case" implant within the current CapLOX II® / TowerLOX® MIS Pedicle Screw System
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 31, 2020
Captiva Spine, Inc. George Chaux Systems & Regulatory Compliance Manager 967 N. Alternate A1A Suite 1 Jupiter, Florida 33477
Re: K193270
Trade/Device Name: CapLOX II®/TowerLOX® MIS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: January 13, 2020 Received: January 15, 2020
Dear George Chaux:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 (OS) 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 medical devices and radiation-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,
for
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193270
Device Name
CapLOX II® / TowerLOX® MIS Pedicle Screw System
Indications for Use (Describe)
The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II® / TowerLOX® MIS Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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| 510(k) Summary: CapLOX II® / TowerLOX® MIS Pedicle Screw System
| Line Extension | |
|---|---|
| Manufacturer / | |
| Submitter | Captiva Spine, Inc. |
| 967 N. Alternate A1A Ste.1 | |
| Jupiter, FL 33477-3206 | |
| Contact Person | George Chaux |
| Systems & Regulatory Compliance Manager | |
| Phone: (877) 772-5571 x719 | |
| Fax: (866) 318-3224 | |
| Email: george.chaux@captivaspine.com and regulatory@captivaspine.com | |
| Date Prepared | November 22, 2019 |
| Trade Name | CapLOX II® / TowerLOX® MIS Pedicle Screw System |
| Common Name | Pedicle Screw System |
| Proposed Class | Class II |
| Classification | |
| Name | Thoracolumbosacral pedicle screw system (21 CFR § 888.3070) |
| Product Code | NKB |
| Classification | |
| Panel | Division of Orthopedic Devices |
| Predicate | |
| Devices | Primary Predicate: |
| • CapLOX II® / TowerLOX® Pedicle Screw System (K131538) | |
| Submission | |
| Scope | The purpose of this submission is the addition of a line extension of a 4.5mm |
| pedicle screw and instrumentation in order to provide additional device | |
| offerings under the CapLOX II® / TowerLOX® MIS Pedicle Screw System | |
| portfolio when performing surgical corrections to the thoracic, lumbar and | |
| sacral spine using minimally invasive surgical techniques. | |
| Device | |
| Description | The CapLOX II® / TowerLOX® MIS Pedicle 4.5mm Screw System is an |
| implant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. | |
| It is to be implanted from the posterior approach. The screws are currently | |
| available in diameters from 4.9-9.0mm and in lengths frOm 30-100mm. The | |
| line extension will include the addition of 4.5mm screws for the CapLOX II® | |
| /TowerLOX® MIS Pedicle Screw System in lengths of 30-55mm. Additional | |
| instrumentation will also be added to the system. Overall, the system includes | |
| pedicle screws, and the instrumentation in order to complete the procedure | |
| and implant construct when performed using minimally invasive surgical | |
| techniques. | |
| Indications for | |
| Use | The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior, |
| non-cervical pedicle fixation system 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 including degenerative | |
| spondylolisthesis with objective evidence of neurologic impairment, fracture, | |
| dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed | |
| previous fusion. | |
| In addition, when used as a pedicle screw fixation system, the CapLOX II® / | |
| TowerLOX® MIS Pedicle Screw System is intended for skeletally mature | |
| patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar- | |
| first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone | |
| graft only, who are having the device attached to the lumbar and sacral spine | |
| (levels may be from L3 to the sacrum/ilium), who are having the device | |
| removed after the attainment of a solid fusion. | |
| Summary of the | |
| Technological | |
| Characteristics | All CapLOX II® / TowerLOX® MIS Pedicle Screws are made from titanium |
| alloy that conforms to ASTM F136. The addition of 4.5mm and | |
| instrumentation have been assessed using risk management techniques and | |
| were concluded as not creating a new worst case when compared against the | |
| predicate devices. The subject and predicate devices have the following | |
| characteristics that are identical: | |
| Indications for Use Materials of manufacture Structural support mechanism The minor differences in the subject and predicate devices were assessed and | |
| concluded as not raising any new issues for safety and effectiveness. | |
| Performance | |
| Data | Engineering Analysis and Dynamic Compression Bending testing per |
| ASTM F1717 were conducted to confirm that introduction of the 4.5mm | |
| pedicle screws perform equivalently to the predicate data and does not | |
| introduce a new "worst case" implant within the current CapLOX II® / | |
| TowerLOX® MIS Pedicle Screw System | |
| Conclusion | The devices associated with this line extension are the same as the previously |
| cleared CapLOX II®/TowerLOX® Pedicle Screw System. There are no | |
| changes in the intended use, indications, technological characteristics and | |
| principles of operation in comparison to the predicate devices. The proposed | |
| modifications raise no new types of safety or effectiveness concerns. The | |
| overall technology characteristics lead to the conclusion that the devices | |
| under the line extension are substantially equivalent to the predicate devices. |
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