(71 days)
No
The device description and intended use focus on mechanical components for spinal fixation and do not mention any AI or ML capabilities.
Yes
The device is described as a "Fixation System" intended to provide "temporary stabilization until a solid spinal fusion develops" for various medical conditions, including degenerative disc disease, fractures, and deformities. These uses fall under the definition of therapy.
No
The device is described as a "supplemental fixation device" and an "anterior fixation device" used to provide "temporary stabilization until a solid spinal fusion develops." Its function is mechanical support and stabilization, not to diagnose a condition.
No
The device description clearly states it consists of physical components like plates and bone screws made of titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is a surgical implant used for spinal fixation. It is a physical device implanted into the body to provide structural support and stabilization.
- Lack of Biological Sample Analysis: There is no mention of this device being used to analyze biological samples or provide diagnostic information based on such analysis.
Therefore, this device falls under the category of a surgical implant/device rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior lateral above the bifurcation (L1-L5) 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 subject device represents an expansion of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. This system consists of a series of 3-hole and 4-hole plates as well as bone screws in a variety of sizes. The 3-hole plates are intended for use as an anterior fixation device while the 4-hole plates are intended for use as an anterior lateral fixation device. The system incorporates a locking mechanism to prevent the bone screws from backing out by covering the bone screw heads. Like its predicate counterpart, the subject device is intended for use as an anterior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons with options in the placement of the device to avoid interference with the vasculature, while still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral level (L5-S1), (L1-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)
Documentation, including mechanical test results, provided has demonstrated that the PYRAMID® +4 Anterior Lumbar Plate System is substantially equivalent to similar previously cleared devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PYRAMID® Anterior Plate Fixation System (K013665), PYRAMID ® +4 Anterior Lumbar Plate System (K071416)
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
APR 3 0 2008
MEDTRONIC Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System 510(k) Summary January 2008
| I. | Company: | Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
(901) 396-3133 |
|-----|--------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | Contact: | Lila Joe
Associate Regulatory Affairs Specialist |
| II. | Product Name: PYRAMID® +4 Anterior Lumbar Plate System | |
Product Name: PYRAMID® +4 Anterior Lumbar Plate System 11. Classification Name: Spinal Intervertebral Body Fixation Orthosis Class II Product Code: KWQ 21 CFR: 888.3060
- Description: The subject device represents an expansion of the PYRAMID® +4 III. ANTERIOR LUMBAR PLATE System. This system consists of a series of 3-hole and 4-hole plates as well as bone screws in a variety of sizes. The 3-hole plates are intended for use as an anterior fixation device while the 4-hole plates are intended for use as an anterior lateral fixation device. The system incorporates a locking mechanism to prevent the bone screws from backing out by covering the bone screw heads. Like its predicate counterpart, the subject device is intended for use as an anterior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons with options in the placement of the device to avoid interference with the vasculature, while still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.
- Indications for Use: The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR IV. LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior lateral above the bifurcation (L1-L5) 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)
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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.
- V. Substantial Equivalence: Documentation, including mechanical test results, provided has demonstrated that the PYRAMID® +4 Anterior Lumbar Plate System is substantially equivalent to similar previously cleared devices such as the PYRAMID® Anterior Plate Fixation System (K013665, SE 12/29/2002) and PYRAMID ® +4 Anterior Lumbar Plate System (K071416, SE 11/1/2007).
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2008
Medtronic Sofamor Danek USA, Inc. % Ms. Michelle Willis 1800 Pyramid Place Memphis, TN 38132
Re: K080429
Trade/Device Name: PYRAMID® +4 Anterior Lumbar Plate System Regulation Number: 21 CFR 888.306 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 11, 2008 Received: April 14, 2008
Dear Ms. Willis:
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, 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.
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Page 2 - Ms. Michelle Willis
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
k 080429 510(k) Number (if known):
Device Name:_PYRAMID® +4 Anterior Lumbar Plate System
Indications for Use:
The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior lateral above the bifurcation (L1-L5) 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 _ X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE TF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Oglan for axm
Cl. ORR
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l. Restorati Division of Gener and Neurological
510(k) Number KD80042