(26 days)
Not Found
No
The device description and intended use focus on mechanical fixation components (plates, screws, bolts, nuts) for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are mechanical testing, not related to algorithmic performance.
Yes.
This device is intended to provide temporary stabilization for spinal fusion and is indicated for various medical conditions of the spine, fulfilling the definition of a therapeutic device.
No
The device is described as an anterior lateral supplemental fixation system intended for temporary stabilization until spinal fusion develops, not for diagnosing conditions.
No
The device description explicitly states that the system consists of physical components such as plates, screws, bolts, and nuts, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation. It is used in vivo (within the body) to provide temporary stabilization for spinal fusion.
- Device Description: The device consists of physical components like plates, screws, bolts, and nuts, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is implanted inside the body.
N/A
Intended Use / Indications for Use
The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration 1. of the disc confirmed by history and radiographic studies).
-
- Pseudoarthrosis.
-
- Spondylolysis.
-
- Spondylolisthesis.
- న. Fracture.
-
- Neoplastic disease.
-
- Unsuccessful previous fusion surgery.
-
- Lordotic deformities of the spine.
-
- Idiopathic thoracolumbar or lumbar scoliosis.
-
- Deformity (i.e., scoliosis, lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
- Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH
Device Description
The XANTUSTM Anterior Lateral Supplemental Fixation System consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. XANTUSTM Anterior Lateral Supplemental Fixation System anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with XANTUSTM Anterior Lateral Supplemental Fixation System. These components include the ZPLATE-ATL™ Anterior Fixation System screws and the DYNA-LOK® Spinal System nut. Refer to those package inserts for proper specific instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterolateral intervertebral bodies from T1 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functionality & Mechanical testing was performed on the Subject XANTUS™ Anterior Lateral Safety Testing: Supplemental Fixation System which determined it to be substantially equivalent to the predicate XANTUS™ Anterior Lateral Supplemental Fixation System. The XANTUS™ Anterior Lateral Supplemental Fixation System is Conclusion: substantially equivalent to K014267, the XANTUSTM Anterior Lateral Supplemental Fixation 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.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
K022070 1/2
JUL 2 2 2002
Medtronic Sofamor Danek XANTUS™Anterior Lateral Supplemental Fixation System 510(k) Summary June 2002
| Submitter: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Treharne |
| Trade Name: | XANTUSTM Anterior Lateral Supplemental Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II |
| Predicate Device(s): | The XANTUSTM Anterior Lateral Supplemental Fixation System
is substantially equivalent to K014267, Medtronic Sofamor Danek
XANTUSTM Anterior Lateral Supplemental Fixation System, which was
cleared on January 25, 2002. |
| Device Description: | The XANTUSTM Anterior Lateral Supplemental Fixation System consists of a
variety of shapes and sizes of plates, screws, bolts, and nuts, as well as
ancillary products and instrument sets. XANTUSTM Anterior Lateral
Supplemental Fixation System anterior implant components can be locked into
a variety of configurations, with each construct being tailor-made for the
individual case. Implant components from other previously cleared Medtronic
Sofamor Danek Spinal Systems can be used in conjunction with XANTUSTM
Anterior Lateral Supplemental Fixation System. These components include the
ZPLATE-ATL™ Anterior Fixation System screws and the DYNA-LOK®
Spinal System nut. Refer to those package inserts for proper specific
instructions for use. |
| Intended Use: | |
The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
00036
1
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. Unsuccessful previous fusion surgery. 7. 8. Lordotic deformities of the spine. Idiopathic thoracolumbar or lumbar scoliosis. 9. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with 10. deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) 11. associated with pelvic obliquity. Functionality & Mechanical testing was performed on the Subject XANTUS™ Anterior Lateral Safety Testing: Supplemental Fixation System which determined it to be substantially equivalent to the predicate XANTUS™ Anterior Lateral Supplemental Fixation System. The XANTUS™ Anterior Lateral Supplemental Fixation System is Conclusion: substantially equivalent to K014267, the XANTUSTM Anterior Lateral Supplemental Fixation System .
KO22070p%
2
Image /page/2/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 an abstract symbol featuring three stylized human profiles facing right, with flowing lines above them that resemble wings or ribbons.
JUL 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
K022070 Re:
Trade/Device Name: XANTUS™ Anterior Lateral Supplemental Fixation System Regulatory Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP, MNH Dated: June 18, 2002 Received: June 26, 2002
Dear Dr. Treharne:
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. Iisting 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 –
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K622670 510(k) Number (if known): _
Device Name: XANTUS™ Anterior Lateral Supplemental Fixation System
Indications for Use:
The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration 1. of the disc confirmed by history and radiographic studies).
-
- Pseudoarthrosis.
-
- Spondylolysis.
-
- Spondylolisthesis.
- న. Fracture.
-
- Neoplastic disease.
-
- Unsuccessful previous fusion surgery.
-
- Lordotic deformities of the spine.
-
- Idiopathic thoracolumbar or lumbar scoliosis.
-
- Deformity (i.e., scoliosis, lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
- Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Prescription Use OR Over-the-counter Use
(Per 21 CFR 801.109)
(Optional 1-2-96)