(50 days)
K213935 Osseus Fusion Systems PISCES™-SA Standalone ALIF Interbody System, K191391, K222270 Globus Medical Inc. HEDRON™ Lumbar Spacers, K081849 Blackstone Medical Pillar SA PEEK Spacer System, K132790 Zimmer Spine InFix Anterior Lumbar System, K210090, K223418 DeGen Medical Impulse AM™ Interbody Fusion System
Not Found
No
The summary describes a physical interbody fusion device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "lumbar interbody fusion device intended for use in patients with degenerative disc disease" and acts as an "adjunct to fusion", directly implying its role in treating a medical condition and restoring function.
No
This device is a lumbar interbody fusion device, which is an implant used for surgical treatment, not for diagnosing conditions.
No
The device description clearly states it is a physical lumbar interbody fusion device made of titanium, with integrated screws. It is a hardware implant, not software.
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 surgical implant used in spinal fusion procedures. It is a physical device implanted into the body to provide structural support and facilitate bone fusion.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical and structural within the body.
Therefore, the Solar™ Lumbar Interbody Fusion System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 radiographic studies. In addition, 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:
When used with three (3) screws, interbody devices with a lordotic angle 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-M™ 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 disc disease (DD), 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-MIM 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, PHM
Device Description
The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for posterior and transforaminal 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. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1), thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to show equivalency:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic compression shear testing per ASTM F2077
- Subsidence testing via ASTM F2267
- Expulsion testing
- Wear debris characterization per ASTM F1877
The results of these studies show the subject DeGen Medical Solar™ Lumbar Interbody Fusion System is substantially equivalent to the 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.
K213935 Osseus Fusion Systems PISCES™-SA Standalone ALIF Interbody System, K191391, K222270 Globus Medical Inc. HEDRON™ Lumbar Spacers, K081849 Blackstone Medical Pillar SA PEEK Spacer System, K132790 Zimmer Spine InFix Anterior Lumbar System, K210090, K223418 DeGen Medical Impulse AM™ Interbody Fusion System
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 16, 2023
DeGen Medical % Justin Gracyalny, MSE Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K231199
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: April 27, 2023 Received: April 27, 2023
Dear Mr. 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K231199
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 radiographic studies. In addition, 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:
When used with three (3) screws, interbody devices with a lordotic angle 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-M™ 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 disc disease (DD), 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-MIM 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows the logo for DeGen Medical. The logo features a stylized graphic of three curved lines emanating from a central point, with each line ending in a circle. The lines are blue, and the circles are a darker shade of blue. Below the graphic, the text "DeGen" is written in a bold, sans-serif font, also in blue. Below "DeGen", the word "Medical" is written in a smaller font.
510(k) Summary of Safety and Effectiveness
| Date | June 14, 2023 |
|---|---|
| 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 | K213935 Osseus Fusion Systems PISCES™-SA Standalone ALIF |
| Interbody System | |
| Additional | |
| Predicates | K191391, K222270 Globus Medical Inc. HEDRON™ Lumbar Spacers |
| K081849 Blackstone Medical Pillar SA PEEK Spacer System | |
| K132790 Zimmer Spine InFix Anterior Lumbar System | |
| K210090, K223418 DeGen Medical Impulse AM™ Interbody Fusion System | |
| Device | |
| Description | The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for posterior and transforaminal 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. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use. |
| Indications for | |
| Use | Solar-ST™ (Standalone, With Integrated Fixation) and Solar-A™ (Non- |
| Standalone, With Integrated Fixation) | |
| The Solar-ST™ (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 radiographic studies. In addition, these | |
| patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the | |
| involved level(s). These patients should be skeletally mature and have had | |
| at least six (6) months of non-operative treatment. Solar-ST™ and Solar-A™ | |
| ALIF Spacers are to be filled with autograft bone and/or allogenic bone | |
| graft composed of cancellous and/or corticocancellous bone. | |
| • Solar-ST™ Used With Screws: | |
| 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. | |
| 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-A™: | |
| 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-M™ 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 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-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). | |
| Technological | |
| Characteristics | Hyperlordotic interbody devices (≥20° lordosis) must be used with at least |
| anterior supplemental fixation. | |
| 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. | |
| 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. | |
| Performance | |
| Testing | The following tests were performed to show equivalency: |
| ● Static and dynamic compression testing per ASTM F2077 | |
| ● Static and dynamic compression shear testing per ASTM F2077 | |
| ● Subsidence testing via ASTM F2267 | |
| ● Expulsion testing | |
| ● Wear debris characterization per ASTM F1877 | |
| 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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