K180475 · Captiva Spine, Inc. · NKB · Mar 19, 2018 · Orthopedic
Device Facts
Record ID
K180475
Device Name
CapLOX II® / TowerLOX® MIS Pedicle Screw System
Applicant
Captiva Spine, Inc.
Product Code
NKB · Orthopedic
Decision Date
Mar 19, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The CapLOX II® / TowerLOX® 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® 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.
Device Story
System comprises pedicle screws, set screws, rods, and instrumentation for posterior spinal fixation via minimally invasive surgical (MIS) techniques. Implants are titanium alloy (Ti-6Al-4V ELI). Surgeons implant devices to stabilize spinal segments during fusion procedures. Line extension adds extended tab pedicle screws, updated tip angles for specific diameters (5.5mm, 6.5mm, 7.5mm), and T25 Torx interface option for set screws. Device provides mechanical support to the spine; aids in achieving solid fusion; intended for removal after fusion attainment.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and risk management assessment of design modifications.
Technological Characteristics
Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Posterior pedicle fixation system. Components: pedicle screws (4.9-9.0mm diameter, 30-100mm length), set screws (5mm hex or T25 Torx), rods, and MIS instrumentation. Mechanical stabilization principle.
Indications for Use
Indicated for skeletally mature patients requiring posterior, non-cervical spinal immobilization/stabilization as an adjunct to fusion. Treats acute/chronic instabilities or deformities (degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, failed fusion). Also indicated for severe spondylolisthesis (Grades 3-4) at L5-S1 using autogenous bone graft, with attachment to lumbar/sacral spine (L3-sacrum/ilium).
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
CapLOX II® / TowerLOX® Pedicle Screw System (K131538)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 19, 2018
Captiva Spine, Inc. Ms. Jackie Ferro Vice President, Quality Assurance & Regulatory Affairs 967 North Alternate A1A. Suite 1 Jupiter, Florida 33477-3206
Re: K180475
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: March 8, 2018 Received: March 12, 2018
Dear Ms. Ferro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K180475
Device Name
CapLOX II® / TowerLOX® MIS Pedicle Screw System
#### Indications for Use (Describe)
The CapLOX II® / TowerLOX® 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® 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) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |
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Image /page/3/Picture/0 description: The image shows the logo for Captiva Spine. The logo features a blue, stylized "S" shape enclosed in a partial circle on the left. To the right of this symbol, the words "CAPTIVA" and "SPINE" are stacked on top of each other in a bold, sans-serif font, also in blue. Below "SPINE" is the website address "captivaspine.com" in a smaller font.
| 510(k) Summary: | CapLOX II® / TowerLOX® MIS Pedicle Screw System |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Line Extension |
| Manufacturer /<br>Submitter | Captiva Spine, Inc.<br>967 N. Alternate A1A Ste.1<br>Jupiter, FL 33477-3206 |
| Contact Person | Jackie Ferro<br>VP Quality Assurance & Regulatory Affairs<br>Phone: (877) 772-5571 x719<br>Fax: (866) 318-3224<br>Email: jackie.ferro@captivaspine.com |
| Date Prepared | March 8, 2018 |
| Trade Name | CapLOX II® / TowerLOX® MIS Pedicle Screw System |
| Common Name | Pedicle Screw System |
| Proposed Class | Class II |
| Classification<br>Name | Thoracolumbosacral pedicle screw system (21 CFR § 888.3070) |
| Product Code | NKB |
| Classification<br>Panel | Division of Orthopedic Devices |
| Predicate<br>Devices | Primary Predicate:<br>• CapLOX II® / TowerLOX® Pedicle Screw System (K131538) |
| Submission<br>Scope | The purpose of this submission is the addition of a line extension for<br>extended tab pedicle screws, accessory fixation devices and instrumentation<br>in order to provide additional device offerings under the CapLOX II® /<br>TowerLOX® MIS Pedicle Screw System portfolio when performing<br>surgical corrections to the thoracic, lumbar and sacral spine using minimally<br>invasive surgical techniques. |
| Device<br>Description | The CapLOX II® / TowerLOX® MIS Pedicle Screw System is an implant<br>device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. It is to<br>be implanted from the posterior approach. The screws are currently<br>available in diameters from 4.9-9.0mm and in lengths from 30-100mm.<br>The line extension will include the addition of 4.9-9.0mm extended tab<br>screws to be marketed as TowerLOX® EXT MIS Extended Tab Pedicle<br>Screws in lengths of 30-100mm. All screws with a 5.5mm, 6.5mm and<br>7.5mm screw diameters will have an updated tip angle. The set screws<br>currently have a 5mm hex, will also be available with a T25 Torx interface.<br>Additional instrumentation will also be added to the system. Overall, the<br>system includes set screws, pedicle screws, and rods with the associated<br>instrumentation in order to complete the procedure and implant construct<br>when performed using minimally invasive surgical techniques. |
| Page 2 of 2 | |
| Indications for<br>Use | The CapLOX II® / TowerLOX® Pedicle Screw System is a posterior, non-<br>cervical pedicle fixation system intended to provide immobilization and<br>stabilization of spinal segments in skeletally mature patients as an adjunct to<br>fusion in the treatment of the following acute and chronic instabilities or<br>deformities of the thoracic, lumbar and sacral spine including degenerative<br>spondylolisthesis with objective evidence of neurologic impairment,<br>fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis and<br>failed previous fusion. In addition, when used as a pedicle screw fixation<br>system, the CapLOX II® / TowerLOX® Pedicle Screw System is intended<br>for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4)<br>of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by<br>autogenous bone graft only, who are having the device attached to the<br>lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who<br>are having the device removed after the attainment of a solid fusion. |
| Summary of the<br>Technological<br>Characteristics | All CapLOX II® / TowerLOX® MIS Pedicle Screws are made from<br>titanium alloy that conforms to ASTM F136. The line extension adds<br>extended tab screws, an updated tip angle on the 5.5mm, 6.5mm, and<br>7.5mm screws and an additional interface for the set screws. These<br>modifications have been assessed using risk management techniques and<br>were concluded as not creating a new worst case when compared against<br>the predicate devices. The subject and predicate devices have the following<br>characteristics that are identical:<br>Indications for Use Materials of manufacture Structural support mechanism The minor differences in the subject and predicate devices were assessed<br>and concluded as not raising any new issues for safety and effectiveness. |
| Conclusion | The devices associated with this line extension are the same as the<br>previously cleared CapLOX II®/TowerLOX® Pedicle Screw System. There<br>are no changes in the intended use, indications, technological characteristics<br>and principles of operation in comparison to the predicate devices. The<br>proposed modifications raise no new types of safety or effectiveness<br>concerns. The overall technology characteristics lead to the conclusion that<br>the devices under the line extension are substantially equivalent to the<br>predicate devices. |
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Image /page/4/Picture/0 description: The image is a logo for Captiva Spine. The logo features a blue, stylized spine on the left side. To the right of the spine is the text "CAPTIVA SPINE" in a bold, sans-serif font. Below the word "SPINE" is the website address "captivaspine.com" in a smaller font.
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