(271 days)
Not Found
No
The summary describes a physical implant device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is indicated for the treatment of degenerative disc disease and is implanted to facilitate spinal fusion, which are therapeutic medical interventions.
No
The device is an intervertebral body fusion system designed for surgical implantation to facilitate fusion, not for diagnosing conditions.
No
The device description explicitly states that the device is surgically implanted and is made of Titanium 6Al-4V ELI, indicating it is a physical implant and not software.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The FortiVy™ OsteoVy™ Lumbar IBF System is a surgically implanted device used for spinal fusion. It is a physical implant placed within the body.
- Intended Use: The intended use is to facilitate fusion of the spine in skeletally mature patients with degenerative disc disease. This is a surgical treatment, not a diagnostic test performed on a sample.
The description clearly indicates a medical device intended for surgical implantation and treatment, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The FortiVyTM OsteoVyTM Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The FortiVy™ OsteoVy™ Lumbar IBF System is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The FortiVy™ OsteoVy™ Lumbar IBF System device is intended to be used as an intervertebral body fusion device. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The FortiVy™ OsteoVy™ Lumbar IBF System device is available in multiple anatomical shapes and sizes to accommodate various vertebral bodies. These include smaller cylindrical and rectangular shapes, elongated elliptical shapes, and larger hemi-cylindrical shapes. The FortiVy™ OsteoVy™ Lumbar IBF components are additively manufactured using Titanium 6Al-4V ELI conforming to ASTM F3001-14. The FortiVy™ OsteoVy™-Ti NanoVy™-HA Lumbar IBF device has been treated with a 20-40 nanoscale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
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)
Axial compression and compressive shear mechanical testing in both static and dynamic loadings (per ASTM F2077) was performed on the FortiVy™ OsteoVy™ Lumbar IBF components. Subsidence testing (per ASTM F2267) was also conducted. The nonclinical tests demonstrate that the FortiVyTM OsteoVy™ Lumbar IBF is as safe, as effective, and performs as well or better than a legally marketed predicate device.
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.
K233807, K223513, K183049, K193370
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image shows the date March 18, 2025. The month is March, the day is the 18th, and the year is 2025. The date is written in a clear, legible font. The text is black on a white background.
Vy Spine, LLC Jordan Hendrickson Quality Operations Manager 545 W 500 South, Suite 100 Bountiful, Utah 84010
Re: K241783
Trade/Device Name: FortiVyTM OsteoVy™ Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 18, 2025 Received: February 18, 2025
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 (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"
1
(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Katherine D. Kavlock -S
for
Brent Showalter, 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
3
Indications for Use
510(k) Number (if known) K241783
Device Name FortiVyTM OsteoVyTM Lumbar IBF System
Indications for Use (Describe)
The FortiVy™ OsteoVy™ Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The FortiVy™ OsteoVy™ Lumbar IBF System is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
| 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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4
510(k) Summary
17 February 2025
Vy Spine, LLC 545 W 500 South Suite 100 Bountiful, UT 84010 Telephone: 866-489-7746 850-597-8571 Fax:
Contact: Jordan Hendrickson Operations Manager
Common or Usual Name: Intervertebral Body Fusion Device FortiVy™ OsteoVy™ Lumbar IBF System Proposed Proprietary or Trade Name: Class II, Intervertebral Body Fusion Device Classification Name: Regulation Number: 21 CFR 888.3080 Product Code: MAX
Substantial Equivalence
The FortiVy™ OsteoVyIM Lumbar IBF System is substantially equivalent to the primary predicate device LumiVy™ Lumbar IBF System (K233807) and the secondary predicate devices UniVy™ Osteo Vy™ Cervical IBF System (K223513), Reliance Lumbar IBF System (K183049) and Nexxt Spine Matrixx System (K193370). The FortiVy™ OsteoVy™ Lumbar IBF System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size, sterility, methods of attachment and use with supplemental fixation.
Device Description
The purpose of this 510(k) submission is to introduce the FortiVy™ OsteoVy™ Lumbar IBF System. The FortiVy™ OsteoVy™ Lumbar IBF System device is intended to be used as an intervertebral body fusion device. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The FortiVy™ OsteoVy™ Lumbar IBF System device is available in multiple anatomical shapes and sizes to accommodate various vertebral bodies. These include smaller cylindrical and rectangular shapes, elongated elliptical shapes, and larger hemi-cylindrical shapes. The FortiVy™ OsteoVy™ Lumbar IBF components are additively manufactured using Titanium 6Al-4V ELI conforming to ASTM F3001-14. The FortiVy™ OsteoVy™-Ti NanoVy™-HA Lumbar IBF device has been treated with a 20-40 nanoscale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
Intended Use/Indications for Use
The FortiVyTM OsteoVyTM Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The FortiVy™ OsteoVyTM Lumbar IBF System is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease
5
(DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
Non-Clinical Testing
Axial compression and compressive shear mechanical testing in both static and dynamic loadings (per ASTM F2077) was performed on the FortiVy™ OsteoVy™ Lumbar IBF components. Subsidence testing (per ASTM F2267) was also conducted.
Technological Modifications
The subject FortiVy™ OsteoVy™ Lumbar IBF System differs from the primary predicate device in terms of utilizing additive manufacturing techniques using Titanium 6A1-4V material. A unique lattice structure mimicking cancellous bone similar to that used in the secondary predicate UniVyTM OsteoVy™ Cervical IBF System device permeates each subject device's footprint.
Technological Characteristics
The subject FortiVy™ OsteoVy™ Lumbar IBF components are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device has equivalent technological characteristics to its predicate devices in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
Conclusions
The nonclinical tests demonstrate that the FortiVyTM OsteoVy™ Lumbar IBF is as safe, as effective, and performs as well or better than a legally marketed predicate device.