(58 days)
Not Found
Not Found
No
The description focuses on the mechanical components and intended use for spinal fixation, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as an "implant" for "temporary stabilization of the anterior spine," directly interacting with the body to address medical conditions like degenerative disc disease, trauma, and tumors. This function aligns with the definition of a therapeutic device.
No
The device is an anterior cervical plate system intended for surgical fixation and temporary stabilization of the cervical spine, not for diagnosing medical conditions.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The X-Spine ACP System is described as a system of titanium alloy plates and bone screws intended for anterior screw fixation to the cervical spine. These are physical implants used in surgery.
- Intended Use: The intended use is for the temporary stabilization of the anterior spine during spinal fusion. This is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates this is a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The X-Spine ACP 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 Anterior Compact Plate (ACP) 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 clear 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
Prescription Use
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)
Performance data were submitted to characterize the X-Spine ACP 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).
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
| JUL 3 0 2004 | 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: | May 28, 2004 |
| Proposed Proprietary | |
| Trade Name: | Anterior Compact Plate (ACP) System |
| Classification Name: | Orthopedics, 888.3060, Class II |
| FDA Product Code | |
| Classification: | KWQ |
| Device Description: | The X-Spine Anterior Compact Plate (ACP) 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 clear | |
| and non-sterile. | |
| Intended Use: | The X-Spine ACP 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. | |
| Predicate Device: | Synthes CSLP System |
| Performance Data: | Performance data were submitted to characterize the X-Spine ACP System. |
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1
Image /page/1/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
X-Spine Systems, Inc. C/o Ms. Janet M. Webb MEDVantage, Inc. 121 W. Chestnut Street, #3506 Chicago, Illinois 60610
Re: K041469
Trade/Device Name: X-Spine Systems Anterior Compact Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 28, 2004 Received: June 2, 2004
Dear Ms. Webb:
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 I ca may , more 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. Janet M. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your a counting of substantial equivalence of your device to a legally premated predicated 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 If you dome of Compliance at (301) 594-4659. 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 other general miornitudes 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/dsma/dsmamain.html
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: X-Spine Systems Anterior Compact Plate System
Indications for Use:
The X-Spine ACP 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 × Over-The-Counter Use __ or (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)
Mark N. Millerson
510(k) Number.
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