(78 days)
Not Found
No
The document describes a mechanical pedicle screw system and its components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are based on mechanical testing, not data analysis or image processing.
Yes
The device is described as "intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities." This directly aligns with the definition of a therapeutic device, which is used to treat or alleviate diseases or conditions.
No
This device is a pedicle screw system intended for spinal stabilization and fusion, which is a treatment rather than a diagnostic function.
No
The device description explicitly lists implant components made of titanium and cobalt chrome alloys, as well as instruments made of PEEK, Tantalum, stainless steel, and aluminum. These are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a system of implants (screws, rods, etc.) and instruments used for surgical implantation to stabilize the spine. This is a surgical device, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
The device is clearly intended for direct surgical intervention within the patient's body.
N/A
Intended Use / Indications for Use
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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: desc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior, non-cervical pedicle, and non-pedicle fixation The Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors of the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP
Device Description
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6Al-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements.
The components include: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes connector and hook components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral, non-cervical, T1 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Evaluation:
The proposed devices were subjected to Static Compression-Bending, Dynamic Compression-Bending and Static Torsion tests per ASTM F1717. The results of these tests were compared to the same results obtained for the primary predicate system. Results show that Lancer™ Open Pedicle Screw System with the proposed connectors does not create a new worst-case construct and is sufficient for its intended use.
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.
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
Choice Spine Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K171456
Trade/Device Name: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: June 16, 2017 Received: June 19, 2017
Dear Ms. Finch:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171456
Device Name
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Indications for Use (Describe)
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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: desc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior, non-cervical pedicle, and non-pedicle fixation The Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors of the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
| 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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3
510(K) Summary
| Date Prepared: | June 16, 2017 |
|---|---|
| Sponsor: | Choice Spine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Manager of Regulatory Affairs |
| Proposed Proprietary | |
| Trade Name: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems |
| Product Class: | Class II |
| Classification Name: | 888.3070 – Thoracolumbosacral Pedicle Screw System |
| Device Product Code: | NKB, KWP |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for additional connectors to |
| the already cleared Lancer™ Open Pedicle Screw System. | |
| Device Description: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems |
| include implant components made of implant grade titanium alloy (Ti-6Al-4V ELI; | |
| ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems | |
| also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), | |
| stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These | |
| components are available in various designs and sizes that allow the surgeon to | |
| build an implant construct suited to a patient's anatomical and physiological | |
| requirements. |
The components include: polyaxial pedicle screws, set screws, rods, instruments
and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes
connector and hook components. |
| Indications: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
are intended to provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the treatment of the |
4
following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior, non-cervical pedicle, and non-pedicle fixation, the Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors on the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems Predicate Devices: K132049 and K160775 (Primary Predicate). K151488 Orthofix FIREBIRD (Additional Predicate)
Summary of Technological
Characteristics:
Substantial equivalence is based on consideration of the following characteristics as well as a non-clinical evaluation, detailed below:
o Intended Use/Indications for Use:
The proposed Lancer™ Open Pedicle Screw System with additional connectors has similar indications as the predicate devices.
-
Materials:
The proposed and predicate systems utilize the same materials in their implants. Those materials are Ti-6Al-4V ELI per ASTM F136 band Co-28Cr-6Mo per ASTM F1537. -
. Design Features:
The proposed connectors and those of the predicate systems have similar design features in regards to style, function and size offerings.
5
Operational Principles:
The proposed connectors and those of the predicate systems have similar operational principles in regards to intended purpose, levels of use, method of attachment and locking mechanism.
● Levels of Attachment:
The proposed and predicate systems can be used in the Thoracic, Lumbar and Sacral/Iliac spine segments.
Non-Clinical Evaluation:
The proposed devices were subjected to Static Compression-Bending, Dynamic Compression-Bending and Static Torsion tests per ASTM F1717. The results of these tests were compared to the same results obtained for the primary predicate system. Results show that Lancer™ Open Pedicle Screw System with the proposed connectors does not create a new worst-case construct and is sufficient for its intended use.
Substantial Equivalence
Conclusion:
Choice Spine concludes that the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems with the additional proposed connectors are equivalent to Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K132049 and K160775; Primary Predicate), as well as the Orthofix FIREBIRD System (K151488; Secondary Predicate). Equivalence is based on similarities in the indications for/intended use, materials, design, product offering, operational principles and levels of attachment. The proposed system is substantially equivalent to the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K132049) based also on mechanical performance. The technological differences between the subject and predicate devices do not raise new questions regarding the safety and effectiveness of the device.