(121 days)
Not Found
No
The document describes a mechanical spinal screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various instabilities, deformities, and conditions of the spine, which aligns with the definition of a therapeutic device designed to treat medical conditions.
No
Explanation: The VyLink™ Spinal Screw System is a pedicle screw system used for immobilization and fusion of spinal segments. It is an implantable device used in treatment, not for diagnosing conditions.
No
The device description clearly lists physical components such as screws, rods, and hooks, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The VyLink™ Spinal Screw System is a surgical implant designed to provide structural support and stabilization to the spine and sacroiliac joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The text clearly describes a system of screws, rods, and hooks used in surgical procedures for spinal and sacroiliac joint fusion and stabilization. This falls under the category of surgical implants or orthopedic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VyLink™ Spinal Screw System is a pedicle screw system 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacraliliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.
The VyLink™ Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis and/or kyphosis), tumor, and previous- failed fusion (pseudarthrosis).
The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.
The 06.5mm and larger screws may be used for sacroiliac joint fusion. The VyLink™ Spinal Screw System when used in the sacroiliac joint is intended for sacroiliac joint fusion for the following conditions:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ, OUR
Device Description
The VyLink™ Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, MIS screws, cannulated screws, fenestrated screws, hooks, reduction hooks, set screws, and transverse connectors.
The VyLink™ Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; L5-S1 vertebra; noncervical spine; sacroiliac joint
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)
No new performance testing has been performed on the subject VyLink™ Spinal System. The subject VyLink™ Spinal System has similar design, materials, sizes, indication of use & biocompatibility as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
October 13, 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.
Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee. Florida 32308
Re: K231744
Trade/Device Name: VyLinkTM Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ, OUR Dated: September 15, 2023 Received: September 15, 2023
Dear Jordan Hendrickson:
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 QS 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 mediation-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,
Colin
O'neill-sFDA
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
510(k) Number (if known) K231744
Device Name VyLink™ Spinal Screw System
Indications for Use (Describe)
The VyLink™ Spinal Screw System is a pedicle screw system 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacraliliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.
The VyLink™ Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous- failed fusion (pseudarthrosis).
The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.
The 06.5mm and larger screws may be used for sacroiliac joint fusion. The VyLink™ Spinal Screw System when used in the sacroiliac joint is intended for sacroiliac joint fusion for the following conditions:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
Vy Spine™, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 Telephone: 866-489-7746 850-597-8571 Fax: Contact: Jordan Hendrickson Operations Manager 510k Number: Common or Usual Name: Spinal Fixation Device Proposed Proprietary or Trade Name: VyLink™ Spinal Screw System Classification Name: Smooth or threaded metallic bone fixation fastener (per 21 CFR 888.3040) Spinal Interlaminal Fixation Orthosis (per 21 CFR 888.3050) Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 888.3060) Spondylolisthesis Spinal Fixation Device System and Pedicle Screw System (per CFR 888.3070) Product Code: NKB, KWP, KWQ, OUR
Substantial Equivalence
The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate VyLink™ Spinal Screw System (K213750) and the additional predicate device SI-BONE iFuse Bedrock Granite Implant System (K222774). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and strength.
Device Description
The VyLink™ Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, MIS screws, cannulated screws, fenestrated screws, hooks, reduction hooks, set screws, and transverse connectors.
The VyLink™ Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.
29 Sep 2023
5
Indications for Use Statement
The VyLink™ Spinal Screw System is a pedicle screw system 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective vidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and ailed previous fusion (pseudarthrosis).
he VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral oine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Vhen used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacral/iliac screw ixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or slocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous ailed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
Vhen used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Crew System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous usion in skeletally-mature patients.
he VyLink™ Spinal Screw System, when used with staples and two rods as an anterior oracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or slocation), spinal stenosis, deformities (scoliosis and/or kyphosis), tumor, and previousiled fusion (pseudarthrosis).
The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.
he Ø6.5mm and larger screws may be used for sacroiliac joint fusion. The VyLink™ Spinal crew System when used in the sacroiliac joint is intended for sacroiliac joint fusion for the ollowing conditions:
Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
Non-Clinical Testing
No new performance testing has been performed on the subject VyLink™ Spinal System. The subject VyLink™ Spinal System has similar design, materials, sizes, indication of use & biocompatibility as the predicate devices.
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K231744 Page 3 of 3
Technological Modifications
The subject VyLink™ Spinal System has the same or similar material, design, sizes, indication of use & biocompatibility as the predicate devices.
Additional indications are being added to the VyLink™ Spinal System.
Conclusion
The subject VyLink™ Spinal System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.