(54 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a fixation system intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which directly addresses a medical condition or disease.
No
The device, VersaLink™ Fixation System, is described as an immobilization system for spinal segments, intended to aid in fusion for various spinal instabilities or deformities. It consists of hardware components like rods, nuts, and screws, designed for physical fixation rather than diagnosing conditions. The document specifies no diagnostic function.
No
The device description explicitly lists multiple hardware components made of Ti-6AI-4V, including rods, nuts, screws, and a crossbar rod, which are physical implants for spinal fixation.
Based on the provided information, the VersaLink™ Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of... instabilities or deformities of the thoracic, lumbar, and sacral spine." This describes a surgical implant used directly on a patient's body for structural support and stabilization.
- Device Description: The device description details the components of a spinal fixation system, including rods, nuts, screws, and a crossbar. These are all physical components designed for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The VersaLink™ system does not interact with or analyze such specimens.
Therefore, the VersaLink™ Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VersaLink™ Fixation System is intended to provide immobilization 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: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; tracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.
Product codes
NKB
Device Description
The VersaLink™ System consists of 6 Ti-6AI-4V main parts:
- The VersaLink rod (the Rod); a spinal fixation rod with a dedicated ring end designed to enable robust attachment to the pedicle screw head above the crossbar.
- Ring nut: dedicated nut designed to be tightened on the Ring Set Screw and firmly fix the VersaLinkTM Rod on the pedicle screw head.
- VersaLink Ring Set Screw Torx: dedicated setscrews with double thread designed to allow attachment of the VersaLink™ Rod device to the head of the pedicle screw above the crossbar.
- Crossbar rod: a bent rod designed to fit the average angle of the lumbar vertebra pedicles. It is horizontally attached to two pedicle screws on the same vertebra in order to reduce peak loads by better distributing the loads between the pedicle screws.
- Polyaxial Pedicle screws
- Torx Setscrew.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
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
The VersaLink™ Fixation System was subjected to static compression, static torsion, and dynamic compression testing per ASTM F1717. All devices functioned and met their acceptance criteria.
Key Metrics
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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November 13, 2018
Premia Spine Ltd. % Janice Hogan, J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K182598
Trade/Device Name: VersaLink™ Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 9, 2018 Received: November 9, 2018
Dear Ms. Hogan:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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
2
Indications for Use
510(k) Number (if known) K182598
Device Name VersaLink™ Fixation System
Indications for Use (Describe)
The VersaLink™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities 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 (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K182598 510(k) SUMMARY Premia Spine's VersaLink™ Fixation System
Premia Spine Ltd. 7 Giborey Israel Street Ramat Poleg, 4250407, Israel
Phone: 972-72-2281200 Facsimile: 972-72-2281201 Contact Person: Mr. Ron Sacher
Date Prepared: November 6, 2018
VersaLink™ Fixation System
21 C.F.R. 888.3070 Pedicle screw spinal system, Class II. Product codes: NKB - orthosis, spinal pedicle fixation, for degenerative disc disease
Primary Predicate
ProMIS™ Fixation System by Premia Spine Ltd. (K150380)
Intended Use / Indications for Use
The VersaLink™ Fixation System is intended to provide immobilization 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: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; tracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.
Device Description
The VersaLink™ System consists of 6 Ti-6AI-4V main parts:
-
- The VersaLink rod (the Rod); a spinal fixation rod with a dedicated ring end designed to enable robust attachment to the pedicle screw head above the crossbar.
-
- Ring nut: dedicated nut designed to be tightened on the Ring Set Screw and firmly fix the VersaLinkTM Rod on the pedicle screw head.
-
- VersaLink Ring Set Screw Torx: dedicated setscrews with double thread designed to allow attachment of the VersaLink™ Rod device to the head of the pedicle screw above the crossbar.
-
- Crossbar rod: a bent rod designed to fit the average angle of the lumbar vertebra pedicles. It is horizontally attached to two pedicle screws on the same vertebra in order to reduce peak loads by better distributing the loads between the pedicle screws.
-
- Polyaxial Pedicle screws
-
- Torx Setscrew.
4
Performance Data
The VersaLink™ Fixation System was subjected to static compression, static torsion, and dynamic compression testing per ASTM F1717. All devices functioned and met their acceptance criteria.
Substantial Equivalence
The VersaLink™ Fixation System and ProMS Fixation System have the same intended use and indication for same users' population.
The subject and predicate systems are made from the same materials and are composed of the same components, including pedicle screws, fusion rods, and set screws, and are operated according to the same principals.
The subject and predicate systems have similar components, made of same materials. Both systems are based on the same pedicle screws and set screws, with identical design, diameter and length. Both systems have fusion rods with similar diameter and length. The subject and predicate systems carry similar accessories and surgical instrumentation set.
Conclusions
The subject VersaLink™ Fixation System is substantially equivalent to the cleared ProMS™ Fixation System. The subject system has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences raise no new issues of safety or effectiveness. Performance data demonstrate that the VersaLink™ Fixation System is substantially equivalent to its predicate.