(25 days)
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is described as a "supplemental fixation construct" intended to "provide temporary stabilization until a solid spinal fusion develops" for various spinal conditions, directly addressing a medical problem.
No
Explanation: The device is a 'Fixation System' used for 'temporary stabilization until a solid spinal fusion develops,' indicating it is a therapeutic or supportive device, not one for diagnosis.
No
The device description explicitly states it consists of plates, screws, ancillary products, and instrument sets made of titanium alloy, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "supplemental fixation device for the lumbosacral level" used to "provide temporary stabilization until a solid spinal fusion develops." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details plates, screws, and instruments made of titanium alloy, designed to be implanted. This aligns with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by 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; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.
Product codes
KWQ
Device Description
The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting of a variety of shapes and sizes of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral level
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)
Mechanical testing was performed on the Subject PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the Predicate PYRAMID™ ANTERIOR PLATE Fixation System
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO21226e p½
MAY 1 3 2002
Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System 510(k) Summary April 2002
| Submitter: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Treharne |
| Trade Name: | PYRAMID™ ANTERIOR PLATE Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II |
| Predicate Device(s): | The PYRAMID™ ANTERIOR PLATE Fixation System is substantially
equivalent to K013665, Medtronic Sofamor Danek PYRAMID™ ANTERIOR
PLATE Fixation System, which was cleared on January 29, 2002. |
| Device Description: | The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental
fixation construct consisting of a variety of shapes and sizes of plates, and
screws, as well as ancillary products and instrument sets. The PYRAMID™
ANTERIOR PLATE Fixation System implant components can be locked into a
variety of configurations, with each construct being tailor-made for the
individual case. The implant components are made of titanium alloy (Ti-6A1-
4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and
titanium implant components must not be used together in a construct. |
| Intended Use: | The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation
System is indicated for use as an anteriorly placed supplemental fixation
device for the lumbosacral level below the bifurcation of the vascular
structures.
When properly used, this system will help provide temporary stabilization until
a solid spinal fusion develops. Specific indications include: 1) Degenerative
disc disease (as defined by 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; 7)
Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9)
Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis,
lordosis, and/or kyphosis) associated with deficient posterior elements such as
that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) |
1
|COR1226 p2/
Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.
Functionality & Safety Testing:
Mechanical testing was performed on the Subject PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the Predicate PYRAMID™ ANTERIOR PLATE Fixation System
Conclusion:
The PYRAMID™ ANTERIOR PLATE Fixation System is substantially equivalent to K013665, the PYRAMID™ ANTERIOR PLATE Fixation System .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes, possibly representing human figures or elements of health and well-being.
MAY 1 3 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
Re: K021226
Trade/Device Name: PYRAMID™ Anterior Plate Fixation System Regulatory Number: 21CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 17, 2002 Received: April 18, 2002
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Richard W. Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 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, (2017) 594-4639 - Radikens at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsible (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N. Mibena
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
4
510(k) Number (if known): CO2 & LD2 & L
Device Name: PYRAMID™ ANTERIOR PLATE Fixation System
Indications for Use:
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by 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; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, 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)
OR
Prescription Use (Per 21 CFR 801.109) Optional 1-2-96)
Mush N. Milkersen
ision of General, Restorative and Neurological Devices
510(k) Number K021226
Over-the-counter Use