(59 days)
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Not Found
No
The description focuses on the mechanical components and intended use of a spinal plating system, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for temporary stabilization during the development of cervical spinal fusion in patients with various spinal conditions, indicating a therapeutic purpose.
No
The X-Spine SCP System is a surgical implant (anterior cervical plates and bone screws) used for temporary stabilization of the anterior spine during fusion, not for diagnosing conditions. Its intended use describes treatment of various spinal conditions, not their identification.
No
The device description explicitly states that the system includes titanium alloy anterior cervical plates and bone screws, which are hardware components.
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, or tissue) to provide information about a person's health.
- Device Description: The X-Spine SCP System is described as a system of titanium alloy plates and screws intended for anterior screw fixation to the cervical spine. This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for temporary stabilization of the anterior spine during spinal fusion. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly indicates that this is a surgical implant used directly on the patient's body, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
The X-Spine SCP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The X-Spine Spider Cervical Plating (SCP) System includes titanium alloy anterior cervical plates and bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The implant components are provided clean and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, levels C2 to C7
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data were submitted to characterize the X-Spine SCP System.
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.
Synthes CSLP 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).
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§ 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
Spider Cervical Plating System 510(k) Application
OCT 2 1 2005
PREMARKET NOTIFICATION 510(K) SUMMARY
| Company: | X-Spine Systems
7026 Corporate Way, #212
Centerville, OH 45459-4288
Telephone: 800/903-0640
Fax: 866/481-0740 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | David Kirschman, MD |
| Date: | August, 19, 2005 |
| Proposed Proprietary
Trade Name: | Spider Cervical Plating (SCP) System |
| Classification Name: | Orthopedics, 888.3060, Class II |
| FDA Product Code
Classification: | KWQ |
| Device Description: | The X-Spine Spider Cervical Plating (SCP) System includes
titanium alloy anterior cervical plates and bone screws. The plate
attaches to the anterior portion of the vertebral body of the cervical
spine, levels C2 to C7. The implant components are provided clean
and non-sterile. |
Intended Use:
The X-Spine SCP System is intended for anterior screw fixation to the cervical The system is indicated for use in the temporary stabilization of the spine. anterior spine during the development of cervical spinal fusion 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), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Synthes CSLP System Predicate Device:
Performance Data: Performance data were submitted to characterize the X-Spine SCP System.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stripes representing the feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Kirschman, MD X-Spine Systems, Inc. 7026 Corporate Way, #212 Centerville, Ohio 45459-4288
Re: K052292
Trade/Device Name: Spider Cervical Plating (SCP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 23, 2005 Received: August 30, 2005
Dear Dr. Kirschman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regions the Medical Device Amendments, or to conimered prior to May 20, 2017 (1 accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains 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 ir your device 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 1 that FDA has made a determination that your device complies with other requirements of the Act that i Drival statutes and regulations administered by other Federal agencies. You must or any I 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- David Kirschman, MD
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/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): __ Kos 22 1 2
Device Name: X-Spine Systems Spider Cervical Plating System
Indications for Use:
The X-Spine SCP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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),
- Spondylolisthesis, .
- Trauma (i.e., fractures or dislocations), .
- Tumors, ●
- Deformity (defined as kyphosis, lordosis, or scoliosis)
- Pseudoarthrosis, and/or
- Failed previous fusions.
| Prescription Use | X | or | Over-The-Counter Use |
|---|---|---|---|
| (21 CFR 801 Subpart D) | (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)
2
(Division Sign-Off Division of General, Restorative. and Neurological Devices
510(k) Number_KOSZZ92