(178 days)
Not Found
No
The summary describes a physical medical device (lumbar interbody fusion system) and its mechanical properties and intended use. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is a lumbar interbody fusion device intended for use in patients with degenerative disc disease, disc herniation, spondylolisthesis, and deformity to achieve fusion, which is a therapeutic purpose.
No
Explanation: The device described is a lumbar interbody fusion device, which is an implant used for surgical treatment of degenerative disc disease, not for diagnosis. Its purpose is to facilitate fusion between vertebrae.
No
The device description clearly states it is a physical implant made of titanium, with integrated fixation components like screws and tusks. It is intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device intended for surgical implantation in the spine to promote fusion between vertebrae. It is a physical implant used in a surgical procedure.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
- Performance Studies: The performance studies described are mechanical tests (compression, shear, pushout) to demonstrate the structural integrity and equivalence to predicate devices, not diagnostic performance based on biological samples.
Therefore, the Solar™ Lumbar Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Solar-S™ (Standalone, With Integrated Fixation) and Solar-A™ (Non-Standalone, With Integrated Fixation) The Solar-STM (Standalone) and Solar-A™ (Non-Standalone) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-A™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
• Solar-STM Used With Screws or Tusks:
When used with three (3) screws, interbody devices with a lordotic angle ≤ 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.
When used with three (3) tusks, interbody devices must always be used with supplemental fixation and may be used at 1 or 2 levels.
Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
• Solar-ATM:
These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Solar-MTM ALIF Spacers (Without Integrated Fixation)
Solar-M™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolilsthesis, deformity (degenerative scoliosis or kyphosis), and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have has at least six (6) months of non-operative treatment. Solar-M™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.
Product codes
MAX, OVD, PHM
Device Description
The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for anterior lumbar fusion procedures. The Solar™ system includes various widths, depths, and heights. The Solar™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature a porous surface to mitigate subsidence and expulsion. The standalone (Solar-S™), anterolateral (Solar-A™), and monolithic (Solar-M™) configurations feature an anterior face with threaded holes and slots to rigidly connect to an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. The DeGen Medical Solar™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ and Solar-A™ incorporate integrated fixation in the form of screws manufactured from Titanium-6AL-4V ELI Alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have
§ 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.
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July 29, 2024
DeGen Medical, Inc. % Justin Gracyalny, MSE Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Hwv Suite 120 Woodstock, Georgia 30188
Re: K240326
Trade/Device Name: Solar™ Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, PHM Dated: July 19, 2024 Received: July 19, 2024
Dear Justin Gracyalny:
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).
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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,
Brent Showalter -S
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
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Indications for Use
510(k) Number (if known) K240326
Device Name Solar™ Lumbar Interbody Fusion System
Indications for Use (Describe)
Solar-S™ (Standalone, With Integrated Fixation) and Solar-ATM (Non-Standalone, With Integrated Fixation) The Solar-STM (Standalone) and Solar-A™ (Non-Standalone) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-A™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
· Solar-STM Used With Screws or Tusks:
When used with three (3) screws, interbody devices with a lordotic angle ≤ 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.
When used with three (3) tusks, interbody devices must always be used with supplemental fixation and may be used at 1 or 2 levels.
Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
· Solar-ATM:
These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Solar-MTM ALIF Spacers (Without Integrated Fixation)
Solar-M™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolilsthesis, deformity (degenerative scoliosis or kyphosis), and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have has at least six (6) months of non-operative treatment. Solar-M™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from a point on the left side of the image. Each line terminates in a blue circle. Below the graphic is the text "DeGen" in a blue sans-serif font, and below that is the word "Medical" in a gray sans-serif font.
510(k) Summary of Safety and Effectiveness
| Date | July 26, 2024 |
|---|---|
| Sponsor | DeGen Medical |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Justin Gracyalny, MSE | |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Solar™ Lumbar Interbody Fusion System |
| Common Name | Intervertebral body fusion device |
| Code- | |
| Classification | MAX, OVD, PHM |
| 21 CFR 888.3080 : Class II | |
| Primary | |
| Predicate | K231199 DeGen Medical Solar™ Lumbar Interbody Fusion System |
| Additional | |
| Predicates | K213935 Osseus Fusion Systems PISCES™-SA Standalone ALIF |
| Interbody System | |
| Device | |
| Description | The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion |
| device for anterior lumbar fusion procedures. The Solar™ system includes | |
| various widths, depths, and heights. The Solar™ device is comprised of a single | |
| component that is additively manufactured. The superior and inferior endplates | |
| feature a porous surface to mitigate subsidence and expulsion. The standalone | |
| (Solar-S™), anterolateral (Solar-A™), and monolithic (Solar-M™) | |
| configurations feature an anterior face with threaded holes and slots to rigidly | |
| connect to an instrument for surgical insertion. Superior and inferior faces | |
| feature a central aperture to constrain bone graft. The DeGen Medical Solar™ | |
| spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The | |
| Solar-S™ and Solar-A™ incorporate integrated fixation in the form of screws | |
| manufactured from Titanium-6AL-4V ELI Alloy per ASTM F136 or tusks | |
| additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ | |
| Lumbar Interbody Spacer must be used with three (3) integrated screws and the | |
| spacer must have 20° lordosis) used with screws must | |
| always be used with supplemental fixation and may be used at 1 or 2 levels. |
• Solar-ATM:
These devices are intended to be used with supplemental fixation systems
that have been cleared for use in the lumbosacral spine (e.g., posterior
pedicle screw and rod systems, anterior plate systems, anterior screw and
rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used
with at least anterior supplemental fixation.
Solar-MTM ALIF Spacers (Without Integrated Fixation)
Solar-MTM ALIF Spacers are lumbar interbody fusion devices indicated at
one or more levels of the thoracic spine (T1-T12), thoracolumbar junction
(T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients
with the following indications: degenerative disc disease (DDD), disc
herniation (with myelopathy and/or radiculopathy), spondylolilsthesis,
deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed
previous fusion (pseudarthrosis). DDD is defined as discogenic back pain
with degeneration of the disc confirmed by history and radiographic
studies. These patients should be skeletally mature and have has at least six
(6) months of non-operative treatment. Solar-MTM ALIF Spacers are to be
filled with autograft bone and/or allogenic bone graft composed of
cancellous and/or corticocancellous bone. These devices are intended to be
used with supplemental fixation systems that have been cleared for use in |
| the thoracolumbosacral spine (e.g., posterior pedicle screw and rod
systems, anterior plate systems, anterior screw and rod systems).
Hyperlordotic interbody devices (≥20° lordosis) must be used with at least
anterior supplemental fixation. | |
| Technological
Characteristics | There are no technological differences between the subject and predicate
device. The technological design features of the subject implants were
compared to the predicates in intended use, indications for use, design, function
and technology and it was demonstrated that they are substantially equivalent. |
| Performance
Testing | Non-clinical testing was performed to demonstrate the DeGen Medical
Solar™ Lumbar Interbody Fusion System is substantially equivalent to
other predicate devices in accordance with "Guidance for Industry and
FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and Class
II Special Controls Guidance Document: Intervertebral Body Fusion
Device, June 12, 2007.
The following tests were performed to show equivalency:
Dynamic compression testing per ASTM F2077 Static and dynamic compression shear testing per ASTM F2077 Axial Tusk Pushout Testing
The results of these studies show the subject DeGen Medical Solar™
Lumbar Interbody Fusion System is substantially equivalent to the predicate
device. |
| Conclusions | Based on the indications for use, technological characteristics, performance
testing, and comparison to the predicate device, the subject DeGen Medical
Solar™ Lumbar Interbody Fusion System is as safe and as effective as the
legally marketed predicate. |
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510(k) Summary of Safety and Effectiveness
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