(104 days)
No
The 510(k) summary describes a mechanical implant (cervical plate system) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The performance studies focus on mechanical testing and substantial equivalence to predicate devices.
Yes
The device is described as a "Cervical Plate System" intended for "anterior interbody fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions" for various medical conditions, indicating a direct therapeutic role in treating physiological conditions.
No
This device is a cervical plate system intended for temporary stabilization and fusion of the cervical spine, not for diagnosing conditions.
No
The device description explicitly states it is comprised of non-sterile, single-use, titanium alloy components, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior interbody fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used directly within the body.
- Device Description: The description details a "cervical plate system" comprised of "titanium alloy components" that "attaches to the vertebral body by means of self tapping and self drilling cervical screws." This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body for structural support.
N/A
Intended Use / Indications for Use
The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 through C7 levels
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)
Testing in accordance with ASTM F1717 was performed and demonstrated that the Reduced Stature VERTEBRON SCP™ Cervical Plate System is substantially equivalent to the DOC Cervical Stabilization System (K982443), ORION Anterior Cervical Plate (K973854), Synthes CSLP (K971883, K000536), ABC Cervical Plate (K974706), EBI VueLock Anterioer Cervical Plate (K010003, K023133) and VERTEBRON SCP™ Cervical Plate System (K040003 and K043181) which have received market clearance by the FDA.
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.
K982443, K973854, K971883, K000536, K974706, K010003, K023133
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
KD51815
Summary of Safety and Effectiveness VIII.
| SUBMITTER: | VERTEBRON Inc.
400 Long Beach Blvd.
Stratford, CT 06615
(203) 380-9340 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luis Nesprido
Regulatory Affairs, Manager |
| DATE PREPARED: | September 2005 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis (888.3060) |
| COMMON NAME: | Cervical Plating System |
| PROPRIETARY NAME: | VERTEBRON SCP™ Cervical Plate System |
| PREDICATE DEVICES: | VERTEBRON SCP™ Cervical Plate System - K040003 and
K043181 |
| DEVICE DESCRIPTION: | The Reduced Stature VERTEBRON SCP™ Cervical Plate System
is comprised of non-sterile, single-use, titanium alloy components.
The VERTEBRON SCP™ Cervical Plate System attaches to the
vertebral body by means of self tapping and self drilling cervical
screws. This system's design is intended to stabilize the spinal
operative site during the fusion process of a bone graft in the disc
space. This submission adds a reduced stature cervical plate. |
| INTENDED USE: | The VERTEBRON SCP™ Cervical Plate System is intended for
non pedicle fixation for the following indications: degenerative disc
disease (defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic
studies); spondylolisthesis; trauma (i.e., fracture or dislocation);
spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or
lordosis); tumor; pseudoarthrosis; and failed previous fusion in
skeletally mature patients. The VERTEBRON SCP™ Cervical
Plate System is intended for non cervical pedicle fixation for the
following indications: spondylolisthesis; trauma (i.e., fracture or
dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis,
and/or lordosis); tumor; pseudoarthrosis; and failed previous
fusion in skeletally mature patients. |
| MATERIALS: | The material used is titanium Alloy material that conforms to
ASTM F136. |
| Substantial Equivalence: | Testing in accordance with ASTM F1717 was performed and
demonstrated that the Reduced Stature VERTEBRON SCP™
Cervical Plate System is substantially equivalent to the DOC
Cervical Stabilization System (K982443), ORION Anterior Cervical |
Page 1 of 2
Plate (K973854), Synthes CSLP (K971883, K000536), ABC
050
1
1051815
Cervical Plate (K974706), EBI VueLock Anterioer Cervical Plate (K010003, K023133) and VERTEBRON SCP™ Cervical Plate
System (K040003 and K043181) which have received market clearance by the FDA.
Page E f ?
051
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, representing healing and medicine. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2005
Luis Nesprido Regulatory Affairs Manager Vertebron, Inc. 400 Long Beach Boulevard Stratford, Connecticut 06615
Rc: K051815
Trade/Device Name: VERTEBRON SCP™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 15, 2005 Received: September 22, 2005
Dear Mr. Nesprido:
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.
3
Page 2- Luis Nesprido
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
V. Indications for Use
ર૦રીશોડ 510(k) Number (if known):
Device Name:
VERTEBRON SCP™ Cervical Plate System
Indications For Use:
The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
× Prescription Use: (Per 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS 1815