(30 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system made of plates and screws. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for conditions like degenerative disc disease, pseudoarthrosis, fractures, and deformities, and it helps provide temporary stabilization until a solid spinal fusion develops, which are all therapeutic purposes.
No
The device is described as an anteriorly placed supplemental fixation device for stabilizing the lumbosacral level until spinal fusion develops, rather than for diagnosing medical conditions.
No
The device description explicitly states it consists of plates, screws, and ancillary products, which are physical 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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a surgical implant system (plates and screws) used to stabilize the spine during fusion surgery. It is a physical device implanted within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic information derived from such tests.
Therefore, based on the provided information, the MEDTRONIC SOFAMOR DANEK PYRAMID® ANTERIOR PLATE Fixation System is a surgical implant, not an In Vitro Diagnostic device.
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, lordosis, and / or kyphosis) associated with pelvic obliquity.
Product codes
KWQ
Device Description
The PYRAMID® ANTERIOR PLATE Fixation System consists of a variety 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 below the bifurcation of the vascular structures, spine, thoracolumbar, lumbar
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
Not Found
Key Metrics
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
PYRAMID® ANTERIOR PLATE Fixation System Summary of Safety and Effectiveness January 2005
- Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
- Richard W. Treharne, PhD Contact: Sr. Vice President, Regulatory Affairs
- Proposed Proprietary Trade Name: PYRAMID® ANTERIOR PLATE Fixation II. System
- Classification Name: Spinal Intervertebral Body Fixation Orthosis, Class II III.
Regulation Number: 21 CFR Sections 888.3050
Code: KWQ
Product Description IV.
The PYRAMID® ANTERIOR PLATE Fixation System consists of a variety 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.
The Medtronic Sofamor Danek PYRAMID® ANTERIOR PLATE Fixation System is intended for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
The purpose of this 510(k) submission is to include modified screws to the PYRAMID® ANTERIOR PLATE Fixation System.
V. Indications
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) anoogento engin >> Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) I bouccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida,
1
or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity
Substantial Equivalence VI.
Documentation was provided which demonstrated the PYRAMID" ANTERIOR PLATE Fixation Documentation was provided with the PYRAMID® ANTERIOR PLATE Fixation System components previously cleared in K013665.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
FEB 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K050117
K050117
Trade Name: PYRAMID™ Anterior Plate Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: January 14, 2005 Received: January 18, 2005
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the device in indicati we have reviewed your bection 9 ro(if) premium 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 encrosary to tegans actment date of the Medical Device Amendments, or to commerce program to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices that have occh recuire approval of a premarket approval application (PMA). and Cosmetic 71ct) that to neviews subject to the general controls provisions of the Act. The r ou may, merciore, market the act include requirements for annual registration, listing of general controls provisions 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 If your device to such additional controls. Existing major regulations affecting your device can thay be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov loand nrther announcements concerning your device in the Federal Register.
3
Page 2 - Richard W. Treharne, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibsudited by our device complies with other requirements of the Act that I DA has made a acterimistions administered by other Federal agencies. You must of any I cut al statures and regulations and limited to: registration and listing (21 Compry with an the Hot 6 requirements) 01); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) by sound of Sections 531-542 of the Act); 21 CFR 1000-1050. product thanation control po begin marketing your device as described in your Section 510(k) I mis ictier with anow you to ogin mailing of substantial equivalence of your device to a legally premaince notineation. The 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 desire specific as not any and (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 other general informational 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 A. Mellarson
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
Page __ of _ January 2005
510(k) Number (if known): K050117
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices