(111 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a spinal system intended for fixation of spinal segments to treat various conditions like degenerative disc disease, spondylolisthesis, and spinal deformities, which directly addresses medical conditions and aims to improve health outcomes, fulfilling the definition of a therapeutic device.
No
The LineSider® Spinal System is a thoracolumbosacral pedicle screw system that provides immobilization and stabilization of spinal segments, which is a therapeutic function, not a diagnostic one. Its intended use is for fixation in conjunction with various spinal conditions, not for identifying or characterizing diseases.
No
The device description explicitly states it is a "thoracolumbosacral pedicle screw system containing metallic implants" and lists various hardware components like screws, hooks, rods, etc. The performance studies also focus on bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for spinal fixation. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of metallic implants (screws, hooks, rods, etc.) used for immobilization and stabilization of spinal segments. This aligns with a surgical implant, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to 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: pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pediction in pediatic patients, LineSider® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, LineSider Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider® Spinal System is intended to be used with autograft. Pediatric pediatic pediatic pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The LineSider® Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation
Indicated Patient Age Range
skeletally mature patients
pediatric 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)
Integrity Implants has conducted bench performance testing in support of this premarket notification submission as follows:
- Static Compression Bending in accordance with ASTM F1717-21 .
- Static Torsion in accordance with ASTM F1717-21
- Dynamic Compression Bending in accordance with ASTM F1717-21
- Static Axial Grip in accordance with ASTM F1798-21
- Static Torsion Grip in accordance with ASTM F1798-21
- Static Flexion-Extension Bending in accordance with ASTM F1798-21 ●
- Static Axial Pull-Off in accordance with ASTM F1798-21 ●
- Static Axial Push-On in accordance with ASTM F1798-21 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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August 7, 2023
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Integrity Implants Inc. Alexa Kamer Regulatory Affairs Specialist 354 Hiatt Drive Palm Beach Gardens, Florida 33418
Re: K231098
Trade/Device Name: LineSider® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: April 14, 2023 Received: April 18, 2023
Dear Alexa Kamer:
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Image /page/1/Picture/5 description: The image contains the name "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. In the background, there is a faint, stylized logo that appears to be the letters "FDA" in a light blue color.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231098
Device Name LineSider® Spinal System
Indications for Use (Describe)
LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to 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: pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pediction in pediatic patients, LineSider® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, LineSider Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider® Spinal System is intended to be used with autograft. Pediatric pediatic pediatic pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable) |
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------------------------------------------------- |
☑ Prescription Use (Part 21 CFR 801 Subpart D) |
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☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
LineSider® Spinal System
April 14, 2023
| I. | Company: | Integrity Implants Inc.
354 Hiatt Drive
Palm Beach Gardens, FL 33418
Telephone: 561-529-3861 |
|------|-------------------------|-------------------------------------------------------------------------------------------------------|
| II. | Contact: | Alexa Kamer
Regulatory Affairs Specialist |
| III. | Proprietary Trade Name: | LineSider® Spinal System |
| IV. | Common Name: | Thoracolumbosacral Pedicle Screw System |
| V. | Classification Name: | Thoracolumbosacral Pedicle Screw System
(21 CFR 888.3070) |
| | Class: | II |
| | Product Code: | NKB, KWP |
VI. Product Description
The LineSider® Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.
VII. Indications for Use
LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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);
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spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
VIII. Summary of Technological Characteristics
LineSider® Spinal System implants are manufactured from Ti-6Al-4V ELI per ASTM F136, Grade 2 CP Ti (commercially pure titanium) ASTM F67, and Co28-Cr6-Mo (cobalt chromium) per ASTM F1537. The implants are provided non-sterile and are intended to be steam sterilized by the user prior to use. The implants are intended to be used with allograft and/or autograft. LineSider® Spinal System implants may be implanted via a posterior surgical approach. The system is used with manual surgical instruments for delivery of the implant device.
LineSider® pedicle screws are currently available in a non-modular configuration, as well as a modular configuration that allows the screws to be assembled in situ. The pedicle screws incorporate a ball and socket poly-axial design to achieve the flexibility and range of motion suitable for meeting varying patient anatomical needs.
The screw tulip heads are available in standard height open and closed versions, as well as with removable extended tabs or removable extended threaded tower heads for a percutaneous approach. The heads have multiple attachment features that allow instrumentation to rigidly affix to the head and assist in screw deployment or rod manipulation
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Set screws are available for mating with open or closed head components. All set screws are fully tightened after positioning of components using a torque limiting handle and counter torque tube to ensure immobilization of the assembled construct.
IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence
Substantial equivalence of the subject LineSider® Spinal System to the following legally marketed predicate devices is claimed:
Primary Predicate: LineSider Spinal System K190360 (SE 06/21/2019) Additional Predicate: LineSider Spinal System K203367 (SE 12/03/2020)
Brief Discussion of the Non-Clinical and Clinical Tests Submitted X.
Integrity Implants has conducted bench performance testing in support of this premarket notification submission as follows:
- Static Compression Bending in accordance with ASTM F1717-21 .
- Static Torsion in accordance with ASTM F1717-21
- Dynamic Compression Bending in accordance with ASTM F1717-21
- Static Axial Grip in accordance with ASTM F1798-21
- Static Torsion Grip in accordance with ASTM F1798-21
- Static Flexion-Extension Bending in accordance with ASTM F1798-21 ●
- Static Axial Pull-Off in accordance with ASTM F1798-21 ●
- Static Axial Push-On in accordance with ASTM F1798-21 ●
XI. Conclusions Drawn for the Non-Clinical and Clinical Tests
Based on the bench performance testing and other supporting documentation provided in this premarket notification, the subject LineSider® Spinal System demonstrates substantial equivalence to legally marketed predicate devices including the previously cleared LineSider Spinal System.