(125 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system made of metal implants and associated instrumentation. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to provide immobilization and stabilization of spinal segments for the treatment of various acute and chronic instabilities or deformities, which is a therapeutic purpose.
No
This device is a spinal fixation system, which is an implant used to stabilize spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is composed of implant devices made from titanium alloy and Cobalt-Chrome, which are hardware components. It also mentions associated instrumentation.
Based on the provided information, the VEOS Spinal Fixation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease or conditions.
- VEOS Spinal Fixation System Function: The VEOS Spinal Fixation System is a surgical implant designed to provide mechanical support and stabilization to the spine. It is used in vivo (within the body) during surgery.
- Intended Use: The intended use clearly states it's for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
- Device Description: The description details the materials and components of the implantable device (screws, rods, connectors) and associated surgical instrumentation. There is no mention of reagents, test strips, or equipment for analyzing biological samples.
Therefore, the VEOS Spinal Fixation System falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1).
The VEOS Spinal Fixation System is intended for noncervical 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, and/or lordosis); tumor: pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VEOS Spinal Fixation System is intended for noncervical 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Pediatric pedicle screw fixation is limited to a posterior approach.
This system is intended to be used with autograft and/or allograft.
Product codes
NKB, KWP
Device Description
The Spineway VEOS Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implants are provided sterile or non-sterile. The implants are to be implanted from the posterior approach. The screws are available as monoaxial reduction screws in multiple diameters and length. Titanium rods are available in two diameters and multiple lengths. CoCr rods are available in one diameter and two length. CoCr rods are only available non-sterile. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided. Screws for MS applications are available as polyaxial cannulated screws in multiple diameters and lengths. Rods for MS applications are available as pre-bent rods and straight rods. Associated instrumentation to complete the procedure is provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine (from T1 to S1)
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
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 structural competence of the VEOS Spinal Fixation System was evaluated by performing a series of tests complying with -ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and -ASTM F1798" Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." Clinical testing was not performed.
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.
K161387, K180179, K954696, K121728
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
October 10, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Spineway % J.D. Webb Consultant The OrthoMedix Group, Inc. 4313 West 3800 South West Haven. Utah 84401
Re: K231658
Trade/Device Name: VEOS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: October 5, 2023 Received: October 6, 2023
Dear J. D. Webb:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, | |||||
|---|---|---|---|---|---|
| EileenDigitally signed by Eileen Cadel -SCadel -SDate: 2023.10.10 16:21:03 -04'00' | Eileen | Digitally signed by Eileen Cadel -S | Cadel -S | Date: 2023.10.10 16:21:03 -04'00' | |
| Eileen | Digitally signed by Eileen Cadel -S | ||||
| Cadel -S | Date: 2023.10.10 16:21:03 -04'00' | ||||
| for | |||||
| 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 |
2
Indications for Use
Submission Number (if known)
Device Name
VEOS Spinal Fixation System
Indications for Use (Describe)
The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1).
The VEOS Spinal Fixation System is intended for noncervical 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, and/or lordosis); tumor: pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VEOS Spinal Fixation System is intended for noncervical 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Pediatric pedicle screw fixation is limited to a posterior approach.
This system is intended to be used with autograft and/or allograft.
| Type of Use (Select one or both, as applicable) |
|---|
| For Instruction Use (Use STF-201 Sales Tax Exemption Certificate) |
| For Resale (Use STF-201 Sales Tax Exemption Certificate) |
| Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
510(k) #: K231658
510(k) Summary
Prepared on: 2023-10-09
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Spineway | |
|---|---|---|
| Applicant Address | 7 allée Moulin Berger Ecully 69130 France | |
| Applicant Contact Telephone | +33614845362 | |
| Applicant Contact | Mr. Maurad Ben Mokhtar | |
| Applicant Contact Email | rd.mbm@spineway.com | |
| Correspondent Name | The OrthoMedix Group, Inc. | |
| Correspondent Address | 4313 West 3800 South West Haven UT 84401 United States | |
| Correspondent Contact Telephone | 512-590-5810 | |
| Correspondent Contact | Mr. J.D. Webb | |
| Correspondent Contact Email | jdwebb@orthomedix.net | |
| Device Name | ||
| 21 CFR 807.92(a)(2) | ||
| Device Trade Name | VEOS Spinal Fixation System | |
| Common Name | Thoracolumbosacral pedicle screw system | |
| Classification Name | Thoracolumbosacral Pedicle Screw System | |
| Regulation Number | 888.3070 | |
| Product Code | NKB | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | NKB |
| K180179 | Firebird Spine System, including the JANUS® Fenestrated Screw | NKB |
| K954696 | Smith Nephew - Rogozinski | KWP |
| K121728 | Tiger Spine System | NKB |
| Device Description Summary | ||
| 21 CFR 807.92(a)(4) | ||
| The Spineway VEOS Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implants are provided sterile or non-sterile. The implants are to be implanted from the |
posterior approach. The screws are available as monoaxial reduction screws in multiple diameters and length.
4
Titanium rods are available in two diameters and multiple lengths. CoCr rods are available in one diameter and two length. CoCr rods are only available non-sterile. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.
Screws for MS applications are available as polyaxial cannulated screws in multiple diameters and lengths. Rods for MS applications are available as pre-bent rods and straight rods.
Associated instrumentation to complete the procedure is provided.
Intended Use/Indications for Use
The VEOS Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronities of the thoracic, lumbar and sacral spine (from T1 to S1).
The VEOS Spinal Fixation System is intended for noncervical 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., scolosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MS instrumentation System is intended for noncervical 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); trauma (i.e., fracture or dislocation); spinal stenosis; curatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pediatic patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatic pedicle screw fixation is limited to a posterior approach.
This system is intended to be used with autograft and/or allograft.
Indications for Use Comparison
The VEOS Spinal Fixation System and the primary predicate have substantially equivalent indications for use.
Technological Comparison
Intended Use:
The VEOS Spinal Fixation System and the provide immobilization and stabilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Material:
The VEOS Spinal Fixation System and the predicle screws are manufactured from Ti6A4V EL. Rods are made from Ti6Al4V ELl or CoCr alloy.
Design/geometry:
The VEOS Spinal Fixation System and the predicates are top loading systems, polyaxial and monoaxial screws. They all include standard and reduction pedicle screws, straight, and pre-bent rods. They also include transverse connectors. The VEOS and Janus screws have cannulations and fenestrations.
Dimensions:
VEOS sizes fit within range of predicate screws.
There are no differences between the VEOS Spinal Fixation System, the Mont Blanc, and Firebird® Spinal Fixation System including JANUS Fenestrated Screws that would affect the substantial equivalence of the devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The structural competence of the VEOS Spinal Fixation System was evaluated by performing a series of tests complying with -ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
5
-ASTM F1798" Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."
Clinical testing was not performed.
Spineway considers the VEOS Spinal Fixation System to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.