(193 days)
No
The device description focuses on patient-specific design based on imaging data and additive manufacturing, but does not mention the use of AI or ML for this process. The performance studies are standard mechanical and usability tests, not AI/ML performance evaluations.
Yes
The device is described as "lumbar interbody fusion devices" and "intervertebral body fusion device" intended for treating conditions such as degenerative disc disease and spondylolisthesis, which aims to alleviate symptoms for patients.
No
The device is described as an "interbody fusion device" and an "intervertebral body fusion device" intended for surgical implantation to facilitate fusion, not to diagnose a condition.
No
The device is a physical implant (lumbar interbody fusion device) that is patient-specific, designed using imaging data. While software is used in the design process, the device itself is a hardware implant.
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-S™ PSI, Solar-A™ PSI, Solar-M™ PSI, and Impulse™ PSI Spacers are lumbar interbody fusion devices intended for surgical implantation in the spine to facilitate fusion in patients with degenerative disc disease and other spinal conditions. They are physical implants, not devices that analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any analysis of biological specimens, diagnostic testing, or any function related to determining a medical condition based on in vitro analysis.
Therefore, this device falls under the category of a surgical implant or medical device used in a surgical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Solar-S™ PSI (Anterior, Standalone, With Integrated Fixation) and Solar-A™ PSI Spacers (Anterior, Non-Standalone, With Integrated Fixation)
The Solar-STM PSI (Standalone) and Solar-ATM PSI (Non-Standalone, With Integrated Fixation) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) of the lumbosacral spine (L1-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-STM PSI and Solar-ATM PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
• Solar-STM PSI Used with Screws or Tusks:
When used with three (3) screws, Solar-STM PSI Spacers 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 one or more levels.
Hyperlordotic interbody devices (>20° lordosis) used with screws or tusks, must always be used with supplemental fixation, and may be used at one or more levels.
When used with supplemental fixation, all Solar-STM PSI Spacers used with screws or tusks may be used at one or more levels.
• Solar-ATM PSI:
These devices are intended to be used at one or more levels 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 PSI Spacers (Anterior, Without Integrated Fixation)
Solar-MTM PSI 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), spondylolisthesis, 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 had at least six (6) months of non-operative treatment. Solar-M™ PSI 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.
Impulse™ PSI Spacers (Posterior / Transforaminal)
The DeGen Medical Impulse™ PSI is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or more levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse™ PSI is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, PHM
Device Description
The DeGen Medical Patient-Specific Implant (PSI) System is a series of patient specific lumbar interbody spacers intended for use in anterior (Solar™ PSI) or posterior / transforaminal (Impulse™ PSI) lumbar fusion procedures. The Impulse™ PSI spacers are available in two configurations: Impulse™ PSI and Impulse™ Hyperlordotic PSI. The Solar™ PSI patient specific spacers are available in three configurations; Solar-S™ (integrated fixation), Solar-A™ (anterolateral, with integrated fixation), and Solar-M™ (monolithic, without integrated fixation). The Solar™ PSI implants incorporate integrated fixation in the form of screws manufactured from Ti-6AL-4V ELI titanium alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ PSI spacers must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use. Impulse™ and Solar™ PSIs are additively manufactured from Puri-Ti™ unalloyed titanium.
The Impulse™ and Solar™ PSIs are designed individually for each patient using patient imaging data (X-Ray, MRI, CT). Variable dimensions include anterior and posterior heights, bone graft window, lordosis, coronal angle, length, and width. When provided with an adequate CT scan, implants may also include patient-matched endplates. All implants are provided in their final geometry and are not intended to be altered or reshaped at the time of surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, MRI, CT
Anatomical Site
lumbosacral spine (L1-S1), thoracic spine (T1-T12), thoracolumbar junction (T12-L1)
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)
Non-clinical testing was performed to demonstrate the DeGen Medical Patient-Specific Implant (PSI) System is substantially equivalent to other predicate devices in accordance with the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007.
The following tests were leveraged from the predicate devices (K240326, K223418) as the subject device PSIs did not create a new mechanical worst case configuration:
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
To validate the patient specific nature of the subject device PSIs, the following testing was also performed:
Intra- and inter-designer variability evaluation
Objective cadaveric study of the usability, form and fit, and accuracy of the patient specific topographical implants
All testing showed that the subject device PSIs are able to be designed and manufactured using the specified work instructions and the manufactured device is able to successfully implement the surgical plan.
The results of these studies show the subject DeGen Medical Patient-Specific Implant (PSI) 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.
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.
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
October 29, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
DeGen Medical % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock, Georgia 30188
Re: K241077
Trade/Device Name: DeGen Medical Patient Specific Implant (PSI) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX. OVD. PHM Dated: September 30, 2024 Received: September 30, 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"
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 -5 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) K241077
Device Name
DeGen Medical Patient-Specific Implant (PSI) System
Indications for Use (Describe)
Solar-S™ PSI (Anterior, Standalone, With Integrated Fixation) and Solar-A™ PSI Spacers (Anterior, Non-Standalone, With Integrated Fixation)
The Solar-STM PSI (Standalone) and Solar-A™ PSI (Non-Standalone, With Integrated Fixation) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) of the lumbosacral spine (L1-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™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
• Solar-STM PSI Used with Screws or Tusks:
When used with three (3) screws, Solar-SIM PSI Spacers 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 one or more levels.
Hyperlordotic interbody devices (>20° lordosis) used with screws or tusks, must always be used with supplemental fixation, and may be used at one or more levels.
When used with supplemental fixation, all Solar-S™ PSI Spacers used with screws or tusks may be used at one or more levels.
· Solar-ATM PSI:
These devices are intended to be used at one or more levels 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 PSI Spacers (Anterior, Without Integrated Fixation)
Solar-M™ PSI 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), spondylolisthesis, 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 had at least six (6) months of non-operative treatment. Solar-M™ PSI Spacers are to be filled with autograft 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 screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
ImpulseTM PSI Spacers (Posterior / Transforaminal) The DeGen Medical Impulse™ PSI is an intervertebral body fusion device intended for use in skeletally mature patients
4
with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or more levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse™ PSI is indicated to be used with autograft comprised of cancellous and for corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
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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5
Image /page/5/Picture/1 description: The image shows the logo for DeGen Medical. The logo features a stylized graphic of three blue circles connected by curved lines, resembling a network or a medical symbol. Below the graphic, the text "DeGen" is written in a bold, blue font, with the word "Medical" appearing in a smaller, gray font underneath.
| Date | October 21, 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 | DeGen Medical Patient-Specific Implant (PSI) System |
| Common Name | Intervertebral body fusion device |
| Code– | |
| Classification | MAX, OVD, PHM |
| 21 CFR 888.3080 : Class II | |
| Primary | |
| Predicate | K240326 DeGen Medical Solar™ Lumbar Interbody Fusion System |
| Additional | |
| Predicates | K223418 DeGen Medical Impulse AM™ Interbody Fusion System |
| K182158 Medicrea International S.A. UNiD Patient-matched PLIF cage | |
| Reference | |
| Devices | K173982 Globus Medical Inc. FORTIFY® Corpectomy Spacers |
| Device | |
| Description | The DeGen Medical Patient-Specific Implant (PSI) System is a series of patient specific lumbar interbody spacers intended for use in anterior (Solar™ PSI) or posterior / transforaminal (Impulse™ PSI) lumbar fusion procedures. The Impulse™ PSI spacers are available in two configurations: Impulse™ PSI and Impulse™ Hyperlordotic PSI. The Solar™ PSI patient specific spacers are available in three configurations; Solar-S™ (integrated fixation), Solar-A™ (anterolateral, with integrated fixation), and Solar-M™ (monolithic, without integrated fixation). The Solar™ PSI implants incorporate integrated fixation in the form of screws manufactured from Ti-6AL-4V ELI titanium alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ PSI spacers must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use. Impulse™ and Solar™ PSIs are additively manufactured from Puri-Ti™ unalloyed titanium. |
The Impulse™ and Solar™ PSIs are designed individually for each patient using patient imaging data (X-Ray, MRI, CT). Variable dimensions include anterior and posterior heights, bone graft window, lordosis, coronal angle, length, and width. When provided with an adequate CT scan, implants may also include patient-matched endplates. All implants are provided in their final geometry and are not intended to be altered or reshaped at the time of surgery |
| Indications for
Use | Solar-STM PSI (Anterior, Standalone, With Integrated Fixation) and Solar-
ATM PSI Spacers (Anterior, Non-Standalone, With Integrated Fixation)
The Solar-STM PSI (Standalone) and Solar-ATM PSI (Non-Standalone,
With Integrated Fixation) are lumbar interbody fusion devices intended
for use in patients with degenerative disc disease (DDD) of the
lumbosacral spine (L1-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-STM PSI and Solar-ATM PSI Spacers are to be filled with autograft
bone and/or allogenic bone graft composed of cancellous and/or
corticocancellous bone. |
| | • Solar-STM PSI Used with Screws or Tusks:
When used with three (3) screws, Solar-STM PSI Spacers 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 one or more levels. |
| | Hyperlordotic interbody devices (>20° lordosis) used with screws or
tusks, must always be used with supplemental fixation, and may be used
at one or more levels. |
| | When used with supplemental fixation, all Solar-STM PSI Spacers used
with screws or tusks may be used at one or more levels. |
| | • Solar-ATM PSI:
These devices are intended to be used at one or more levels 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 PSI Spacers (Anterior, Without Integrated Fixation)
Solar-MTM PSI 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), spondylolisthesis,
deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed
previous fusion (pseudarthrosis). DDD is defined as discogenic back pain |
| Technological
Characteristics | with degeneration of the disc confirmed by history and radiographic
studies. These patients should be skeletally mature and have had at least
six (6) months of non-operative treatment. Solar-M™ PSI 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.
Impulse™ PSI Spacers (Posterior / Transforaminal)
The DeGen Medical Impulse™ PSI is an intervertebral body fusion device
intended for use in skeletally mature patients with Degenerative Disk
Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis
at one or more levels from L1-S1. DDD is defined as discogenic back pain
with degeneration of the disc confirmed by history and radiographic
studies. The DeGen Medical Impulse™ PSI is indicated to be used with
autograft and/or allograft comprised of cancellous and/or corticocancellous
bone graft to facilitate fusion and are intended to be used with supplemental
fixation systems cleared for use in the lumbar spine. The device is to be
used in patients who have had six months of nonoperative treatment.
The subject is identical in intended use, indications for use, design, function and
technology to the predicate devices.
The primary difference between the subject and predicate devices relates to the
subject device being patient specific while the predicate device is offered in
predetermined sized. This difference is addressed via performance testing and
inclusion of the additional predicate device (K182158). The limits of the subject
device patient specific offerings are within those limits cleared in the predicate
devices (K240326, K223418, K182158) and reference device (K173982).
In conclusion, 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
Patient-Specific Implant (PSI) System is substantially equivalent to
other predicate devices in accordance with the Class II Special
Controls Guidance Document: Intervertebral Body Fusion Device, June
12, 2007.
The following tests were leveraged from the predicate devices (K240326,
K223418) as the subject device PSIs did not create a new mechanical
worst case configuration:
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 To validate the patient specific nature of the subject device PSIs, the
following testing was also performed:
Intra- and inter-designer variability evaluation Objective cadaveric study of the usability, form and fit, and
accuracy of the patient specific topographical implants All testing showed that the subject device PSIs are able to be designed and
manufactured using the specified work instructions and the manufactured
device is able to successfully implement the surgical plan.
The results of these studies show the subject DeGen Medical Patient-
Specific Implant (PSI) 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
Patient-Specific Implant (PSI) System is as safe and as effective as the
legally marketed predicate. |
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Image /page/6/Picture/1 description: The image shows the logo for DeGen Medical. The logo features three blue circles connected by curved lines, resembling a stylized representation of medical technology or innovation. Below the symbol, the text "DeGen Medical" is written in a clear, sans-serif font, with "DeGen" in a larger, bolder typeface than "Medical."
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Image /page/7/Picture/1 description: The image shows the logo for DeGen Medical. The logo features three blue arcs emanating from three blue circles. The arcs are arranged in a cascading fashion, with the largest arc at the bottom and the smallest at the top. Below the graphic is the text "DeGen" in a bold, blue font. Below that is the word "Medical" in a smaller, gray font.
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Image /page/8/Picture/1 description: The image shows the logo for DeGen Medical. The logo features a stylized graphic of three blue arcs emanating from three blue circles, resembling a network or connection symbol. Below the graphic, the text "DeGen" is written in a bold, blue font, and underneath that, the word "Medical" is written in a smaller, gray font.