(182 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "vertebral body replacement device" used to replace a "collapsed, damaged or unstable vertebral body due to tumor or trauma," which directly addresses and treats a medical condition.
No
The device description clearly states it is a "vertebral body replacement device" intended for surgical implantation, not for diagnosis.
No
The device description explicitly states it is a vertebral body replacement device manufactured from titanium alloy, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The STGC-Lordotic is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to provide structural support in the thoracolumbar spine due to tumor or trauma. This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
The information provided clearly describes a surgical implant, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.
Product codes
MQP
Device Description
STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: performance testing, engineering analysis and dimensional analysis. Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043.
Clinical data were not submitted in this premarket notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Cardinal Spine, LLC % Kevin Thomas, Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K142030
Trade/Device Name: STGC-Lordotic Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 22, 2014 Received: December 23, 2014
Dear Dr. Thomas:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Kevin Thomas, Ph.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142030
Device Name STGC-Lordotic
Indications for Use (Describe)
STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.
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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510(k) Summary Cardinal Spine, LLC STGC-Lordotic K142030
December 22, 2014
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Cardinal Spine, LLC
12307 Old LaGrange Road, Suite 105
Louisville, KY 40245 |
|-------------------|-----------------------------------------------------------------------------------|
| Telephone: | +1 (502) 777-4788 |
| Fax: | +1 (502) 245-5768 |
| Official Contact | Natasha Lonnon
Vice President |
Representative/Consultant Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: kthomas@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | STGC-Lordotic |
|---|---|
| Common Name: | Vertebral body replacement device |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Regulations: | |
| Product Code: | 21 CFR 888.3060, Class II |
| MQP | |
| Classification Panel | |
| Reviewing Branch | Orthopedic and Rehabilitation Devices Panel |
| Anterior Spine Devices Branch (ASDB) |
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INDICATIONS FOR USE
STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.
DEVICE DESCRIPTION
STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: performance testing, engineering analysis and dimensional analysis. Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043.
Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICE
Cardinal Spine, LLC has submitted information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, STGC-Lordotic is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
STGC, Cardinal Spine LLC, K121176,
MaxFuse VBR System. Pioneer Surgical Technology, Inc., K131724, and
Surgical Titanium Mesh System, DePuy AcroMed, K003043.
The primary predicate device is K121176.
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The intended use, design, materials, and functional characteristics of the STGC-Lordotic and the predicate device STGC are substantially the same. The subject device and the predicate device STGC encompass a similar range of physical dimensions, and have similar design characteristics. The subject device and the predicate device MaxFuse VBR System also encompass a similar range of physical dimensions including the lordosis intrinsic to the devices. Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.
The subject and predicate devices all are intended to be used to provide support after resection or removal of a damaged, collapsed, or unstable vertebral body due to tumor, fracture, or other disease. The subject device and predicate devices are placed within the area of removed or resected spine and are functionally complemental internal fixation. The subject device and the predicate devices are intended to be used with bone graft.
CONCLUSION
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Overall, STGC-Lordotic has the following similarities to the predicate devices:
- has the same intended use, ●
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials, and ●
- is to be sterilized using the same processes. ●