(55 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is used to stabilize and buttress bone grafts/intervertebral body fusion devices, which is a therapeutic intervention for degenerative disc disease.
No
Explanation: The device is a surgical implant designed to stabilize bone grafts and intervertebral body fusion devices, not to diagnose a condition.
No
The device description explicitly states that the system is comprised of plates and screws manufactured from titanium alloy, indicating it is a hardware medical device.
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 and Intended Use: The provided text clearly describes a surgical implant system (plates and screws) used for stabilizing the spine during fusion procedures. It is a physical device implanted into the body, not a device that analyzes biological samples.
The information provided describes a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Spinal Elements Buttress Plate System is intended for anterior intravertebral body screw fixation/attachment to one vertebral body of the L1-S1 spine, extending over the adjacent intervertebral space to stabilize and buttress bone grafts/intervertebral body fusion devices following reconstruction for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The system is intended to be used in skeletally mature patients in conjunction with traditional fixation and is not intended for load bearing applications.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Spinal Elements Buttress Plate System is comprised of plates and screws that are used for attachment to the anterior lumbar spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1-S1 spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
§ 888.3060 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.
0
510(k) Summary Spinal Elements Buttress Plate System
510(k) Number KO 81418
JUL 1 4 2008
| Manufacturer Identification
Submitted by: | Spinal Elements, Inc.
2744 Loker Ave. W., Suite 100
Carlsbad, CA 92010
760-607-0121 |
|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kerri DiMartino
Regulatory Affairs Specialist
Spinal Elements, Inc.
2744 Loker Ave. W., Suite 100
Carlsbad, CA 92010
760-607-1816
kdimartino@spinalelements.com |
| Date Prepared: | May 19, 2008 |
| Device Identification
Proprietary Name
Common Name
Device Classification
Proposed Regulatory Class
Device Product Code | Spinal Elements Buttress Plate System
Spinal Intervertebral Body Fixation Orthosis
21 CFR 888.3060: Appliance, Fixation, Spinal,
Intervertebral Body
Class II
KWQ |
Device Description
The Spinal Elements Buttress Plate System is comprised of plates and screws that are used for attachment to the anterior lumbar spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.
Intended Use of the Device
The Spinal Elements Buttress Plate System is intended for anterior intravertebral body screw fixation/attachment to one vertebral body of the L1-S1 spine, extending over the adjacent intervertebral space to stabilize and buttress bone grafts/intervertebral body fusion devices following reconstruction for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The system is intended to be used in skeletally mature patients in conjunction with traditional fixation and is not intended for load bearing applications.
Substantial Equivalence
The Spinal Elements Buttress Plate System is substantially equivalent to predicates, K2M Cayman Buttress Plate System (K080302) and the Synthes TiLPS (K970048), in regard to indications for use, material, general design features, and function.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal Elements, Inc. % Ms. Kerri DiMartino 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010
JUL 1 4 2008
Re: K081418
Trade/Device Name: Spinal Elements Buttress Platc Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 19, 2008 Received: May 20, 2008
Dear Ms. DiMartino:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
2
Page 2 - Ms. Kerri DiMartino
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Spinal Elements Buttress Plate System
Indications for Use:
The Spinal Elements Buttress Plate System is intended for anterior intravertebral body screw fixation/attachment to one vertebral body of the I.1-S1 spine, extending over the adjacent intervertebral space to stabilize and buttress bone grafts/intervertebral body fusion devices following reconstruction for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The system is intended to be used in skeletally mature patients in conjunction with traditional fixation and is not intended for load bearing applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clara Bueno
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number_K081418