(269 days)
No
The device description and performance studies focus on mechanical properties, material characteristics, and the ultrasonic delivery of a polymer, with no mention of AI or ML for analysis, prediction, or control.
Yes
The device is described as "intended to provide immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and/or failed previous fusion," which are all conditions that are cured or alleviated by the device, establishing it as a therapeutic device.
No
The device description and intended use clearly state that the Elaris Pedicle Screw System is designed for the immobilization of spinal segments as an adjunct to fusion, treating various spinal conditions by mechanically fixing pedicles and optionally injecting a polymer. It is a surgical implant system, not a device used to diagnose medical conditions.
No
The device description clearly lists multiple hardware components including screws, pins, rods, set screws, manual instruments, and an ultrasonic system with a generator, footswitch, power cord, and handpiece. The performance studies also focus on the mechanical and material properties of these hardware components.
Based on the provided information, the Elaris Pedicle Screw System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The description details components like screws, rods, set screws, and an ultrasonic system used for implanting and securing the device within the body. These are all components of a surgical implant system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Elaris Pedicle Screw System does not interact with or analyze such specimens.
Therefore, the Elaris Pedicle Screw System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The Elaris Pedicle Screw System is intended to provide immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed above.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The ELARIS Pedicle Screw System consists of the following components: Elaris Pedicle Screws, Elaris Pins, Elaris Rod, Elaris Set Screw, Dedicated Manual Instruments, and an Ultrasonic System, which includes the ultrasonic generator (BoneWelder 150-W1) with corresponding footswitch and power cord, and the spring loaded Elaris Handpiece with the Elaris Connector, which rigidly couples the housing of the Elaris Handpiece with the Elaris Pedicle Screw.
The cannulated pedicle screws are available in two diameters and four lengths and contain a distal fenestration to optionally allow injection of resorbable polymer into the cancellous bone of the vertebral body. The Ti alloy screws are multiaxial, and are rigidly attached to the set screw. The Elaris Pin can intraoperatively be inserted into the screws cannulation. The Elaris handpiece can be connected to the pedicle screw head, and using the BoneWelder, the polymer is ultrasonically heated so that it melts and is extruded out of the fenestrations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments (non-cervical), pedicle
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)
The following tests were performed to demonstrate the substantial equivalence of the Elaris Pedicle Screw:
- IEC 60601-1 and 60601-1-2 testing of the handpiece.
- Static and dynamic axial compression testing and torsion testing per ASTM F1717
- Dynamic screw pull out testing to assess effect of polymer enhancement
- Dynamic toggle testing to assess effect of polymer enhancement
- Polymer characterization testing (before and after melting and throughout degradation)
- Temperature distribution characterization during polymer enhancement
- Screw removal testing
- Cavitation risk assessment
- Polymer swelling risks assessment
- Polymer flow distance analysis
- FEA of screw loading with distal fixation
- Spine fusion animal study to assess bioresponse to Elaris
- Dynamic screw pullout testing
- Screw removal testing
Key results:
Testing per ASTM F1717 for lumbar systems has demonstrated equivalent mechanical strength to cleared pedicle screw systems. The polymer used in the device has been characterized and verified that it is not significantly altered by melting. Bench testing has demonstrated that the polymer enhancement provides improved dynamic pullout strength out to 52 weeks as well as improved resistance to toggle loosening. Finally, testing has also demonstrated that the screws can be safely removed after polymer enhancement.
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.
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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August 2, 2019
SpineWelding AG % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K183091
Trade/Device Name: Elaris Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 2, 2019 Received: July 2, 2019
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
1
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 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,
Ronald P. Jean, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page
510(k) Number (if known) K183091
Device Name
Elaris Pedicle Screw System
Indications for Use (Describe)
The Elaris Pedicle Screw System is intended to provide immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed above.
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY SpineWelding's Elaris Pedicle Screw System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
SpineWelding AG Wagistrasse 6 Schlieren. Switzerland Phone: +41 44 204 61 21 Facsimile: +41 44 204 61 20 Contact Person: Joerg Mayer, Managing Director, CTO
Date Prepared: Auqust 2, 2019
Name of Device and Name
Elaris Pedicle Screw System
Common or Usual Name
Thoracolumbosacral pedicle screw system (NKB), class II
Classification Name
Thoracolumbosacral pedicle screw system (21 CFR 888.3070)
Predicate and Reference Devices
- K170347, Medtronic's CD Horizon Pedicle Screw System (Primary Predicate)
- K171228, SportWelding Fiji Anchor (Reference Device) ●
- K073439, Globus Medical Transition Stabilization System (Reference Device) .
Indications for Use
The Elaris Pedicle Screw System is intended to provide immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed above.
Technological Characteristics
The ELARIS Pedicle Screw System consists of the following components: Elaris Pedicle Screws, Elaris Pins, Elaris Rod, Elaris Set Screw, Dedicated Manual Instruments, and an Ultrasonic System, which includes the ultrasonic generator (BoneWelder 150-W1) with corresponding footswitch and power cord, and the spring loaded Elaris Handpiece with the Elaris Connector, which rigidly couples the housing of the Elaris Handpiece with the Elaris Pedicle Screw.
The cannulated pedicle screws are available in two diameters and four lengths and contain a distal fenestration to optionally allow injection of resorbable polymer into the cancellous bone of the vertebral body. The Ti alloy screws are multiaxial, and are rigidly attached to the set screw. The Elaris Pin can intraoperatively be inserted into the screws cannulation. The Elaris handpiece can be
4
connected to the pedicle screw head, and using the BoneWelder, the polymer is ultrasonically heated so that it melts and is extruded out of the fenestrations.
Performance Data
The following tests were performed to demonstrate the substantial equivalence of the Elaris Pedicle Screw:
- IEC 60601-1 and 60601-1-2 testing of the handpiece .
- . Static and dynamic axial compression testing and torsion testing per ASTM F1717
- Dynamic screw pull out testing to assess effect of polymer enhancement ●
- Dynamic toggle testing to assess effect of polymer enhancement ●
- . Polymer characterization testing (before and after melting and throughout degradation)
- Temperature distribution characterization during polymer enhancement
- Screw removal testing
- . Cavitation risk assessment
- Polymer swelling risks assessment
- Polymer flow distance analysis
- FEA of screw loading with distal fixation
- . Spine fusion animal study to assess bioresponse to Elaris
- Dynamic screw pullout testing .
- Screw removal testing .
Comparison to the Predicate Device
The Elaris Pedicle Screw that is part of the subject system falls within the range of cleared screw sizes marketed for the CD Horizon Legacy Spinal System (see comparison table below). The screws in both spinal systems are comprised of the same material. In addition, the Elaris Pedicle Screw and the predicate screws are inserted manually using standard surgical techniques for pedicle screws. While the Elaris Pedicle Screw utilizes a bioresorbable polymer forming a solid ring-like interface around the tip of the screw designed for initial enhanced fixation, the predicate spinal system uses hydroxyapatite ("HA") on certain components as a means of enhanced fixation. In addition, FDA has cleared numerous pedicle screws coated with HA to enhance the fixation of pedicle screws in the spine and thus, increase the pull out resistance of these screws.
With regard to the method of insertion, the subject device differs slightly from the CD Horizon in that the predicate implant relies solely on thread fixation in bone. In contrast, the subject system is comprised of a titanium alloy pedicle screw and, optionally, a bioresorbable polymer (PLDLLA) pin in which the simultaneous activation of ultrasonic energy and automated (spring-loaded) axial movement of the handpiece result in the temporary, local, and controlled melting of the tip of the Elaris Pedicle Screw. During this process, the polymer infiltrates the three dimensional, superficial bone structures adjacent to the Elaris Pedicle Screw and, following a rapid solidification due to immediate cooling, forms a strong initial interface between the tip of the Elaris Pedicle Screw and the adjacent bone. Thus, the Elaris Pedicle Screw optionally relies on an additional polymeric component designed to enhance initial fixation, whereas the predicate CD Horizon relies on thread fixation only. While this and the other minor differences outlined above could affect the safety and effectiveness, these differences do not raise new questions of safety and effectiveness. Rather, the subject system and the predicate device raise the same questions with regard to method of pedicle screw insertion, stability of screws, and bioresponse to implants.
Any risks associated with the device are not new risks to pedicle screw systems as damage to bone or soft tissue is always possible due to misplaced screws as is adverse biological reactions. The
5
company has performed animal testing to assess these risks and the completed testing demonstrates that the device has an equivalent benefit risk profile as cleared predicate devices.
Testing per ASTM F1717 for lumbar systems has demonstrated equivalent mechanical strength to cleared pedicle screw systems. The polymer used in the device has been characterized and verified that it is not significantly altered by melting. Bench testing has demonstrated that the polymer enhancement provides improved dynamic pullout strength out to 52 weeks as well as improved resistance to toggle loosening. Finally, testing has also demonstrated that the screws can be safely removed after polymer enhancement.
| | SpineWelding Elaris Pedicle
Screw System | Medtronic CD Horizon |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 510(k) | Subject | K170347 |
| Components | Fenestrated, cannulated, polyaxial
pedicle screws
Metallic rods
Elaris Pin
BoneWelder + Handpiece | Fenestrated, cannulated,
polyaxial pedicle screws
Metallic rods |
| Pedicle Screw Size | 6.5 – 7.5 mm diameter
40 – 60 mm length | 4.5 – 10.5 mm diameter
30 – 100 mm length |
| Rod Lengths | 40 – 100 mm, 350 mm | Unknown |
| Insertion Method | Rotate screw into pilot hole | Rotate screw into pilot hole |
| Fixation Method | Screw threads in bone,
Optionally, polymer enhancement | Screw threads in bone |
| Length of ultrasound
energy delivery | Not more than 8 seconds | N/A |
| Implant Material | Ti alloy
PLDLLA (pin) | Ti alloy, CoCr |
| Resorbable | Partly | No |
| Sterilization | Sterile (pin)
Non-sterile (all other components) | Sterile (cement)
Non-Sterile (screws) |
Conclusions
The Elaris Pedicle Screw System performs as intended and is substantially equivalent to the predicate device.