(164 days)
K01:665, K022070
No
The summary describes a mechanical spinal fixation device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "anteriorly placed supplemental fixation device" and its intended use is to "help provide temporary stabilization until a solid spinal fusion develops" for various medical conditions of the spine. These functions indicate it is used to treat or alleviate a disease or injury.
No
Explanation: The device is an anteriorly placed supplemental fixation device used to provide temporary stabilization until a solid spinal fusion develops. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the components are made of titanium alloy, indicating a physical hardware device.
Based on the provided text, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is a supplemental fixation device for the spine. It is surgically implanted to provide temporary stabilization during spinal fusion.
- Lack of Diagnostic Function: The device's purpose is mechanical support and stabilization, not the analysis of biological samples for diagnostic purposes.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.
When properly used, this system will ielp 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) Neo )lastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scolio is, lordosis, and/or kyphosis) associated with deficient posterior elements such as t at resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : 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; L1-L5 region
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)
Substantial Equivalence: Documents tion, including mechanical test results, provided V. 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 (K01:665, 12/29/2002) and the XANTUS® Anterior Lateral Supplemental Fixation System (K022070, SE 07/22/02).
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.
K01:665
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.
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
NOV - 1 2007
MEDTRONIC Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System 510(k) Summary May 2007
| I. | Company: | Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
(901) 396-3133 |
|-----|----------------------|---------------------------------------------------------------------------------------------------|
| | Contact: | Christine Sciert, Regulatory Affairs Group Director |
| II. | Product Name: | PYRAMID® +4 Anterior Lumbar Plate System |
| | Classification Name: | Spinal Interaminal Fixation Orthosis |
| | Class II | Product Code: KWQ |
| | 21 CFR: | 888.3060 |
- III. Description: The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.
- IV, Indications for Use: The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.
When properly used, this system will ielp 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) Neo )lastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scolio is, lordosis, and/or kyphosis) associated with deficient posterior elements such as t at resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.
1
- Substantial Equivalence: Documents tion, including mechanical test results, provided V. 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 (K01:665, 12/29/2002) and the XANTUS® Anterior Lateral Supplemental Fixation System (K022070, SE 07/22/02).
2
PYRAMID® +4 ANTERIOR I UMBAR PLATE System 510(k) APPLICATION
NOTICE
The enclosed materials and descriptions contain information, which is trade secure or confidential under 21 CFR 20,61 and not disclosable to the public under the Freedom of Information Act (FOIA). If you are not able to assure us that the enclosed information will not be disclosed to the public, we request that this submission be handled by FDA in accordance with 21 CFR 20.44 relating to presubmission reviews. Consequently, until you hear otherwise from us, we ask that you keep our application for this device confidential. We consider this premarket notification confidential information. If we disclose this application to anyone except consultants or employe es, we will notify the FDA.
Submitter Information I .
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: 901-396-3133 Telefax: 901-346-9738 Contact; Christine Scifert Director, Regulatory Affairs
Manufacturing Facilities
Warsaw Orthopedic, Inc. (also known as) Medtronic Sofamor Danek Manufacturing, Inc. 2500 Silveus Crossing Warsaw, Indiana 46582 Telephone: 219-267-6826
Medtronic Puerto Rico Operations Co., med Rel Road 909, KM.0.4 Barrio Mariana Humacao, PR 00792
Device Name
Common or Usual Name: Metallic B