(34 days)
No
The device description focuses on mechanical components (hooks, screws, plates, spacers) for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described with indications for use that include treating various medical conditions affecting the spine, such as spondylolisthesis, trauma, spinal stenosis, and curvatures, which aligns with the definition of a therapeutic device.
No
The document describes the BASIS™ Spinal System as an implantable device used for posterior, non-cervical fixation and vertebral body replacement, and it does not mention any diagnostic functions.
No
The device description explicitly lists physical components made of medical grade titanium alloy, such as hooks, screws, bolts, nuts, plates, and vertebral body spacers. This indicates it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for posterior, non-cervical fixation and vertebral body replacement in the spine. These are surgical procedures performed directly on the patient's body.
- Device Description: The device components are described as hooks, screws, bolts, nuts, plates, and vertebral body spacers, which are all physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat structural issues in the spine.
N/A
Intended Use / Indications for Use
The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is used in corpectomy procedures in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Danek BASIS™ Anterior Thoracolumbar Plates, Multi-Axial Screws, or Fixed Angle Screws. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.
Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Posterior surgical implantation. The BASIS™ Anterior Cervical Plates are intended for posterior surgical intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only.
Product codes
KWQ, KWP, MNH, MNI
Device Description
The BASIS™ Spinal System consists of a variety of shapes and sizes of hooks, screws, bolts, nuts, plates, and vertebral body spacers, as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.
BASIS™ hooks are intended for posterior use only.
The BASIS™ Spinal System implant components are made from medical grade titanium alloy. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.
BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the BASIS™ Anterior Thoracolumbar Plate, the BASIS™ Multi-Axial Screws, or the BASIS™ Fixed Angle Screws must be used with the BASIS™ Vertebral Body Spacers.
To achieve best results, do not use any of the BASIS™ components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic implants, none of the BASIS™ components should ever be reused under any circumstances.
The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, thoracolumbar spine (T1-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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 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
K06008
FEB 1 3 2006
BASISTM Spinal System - Crosslink® Plates Summary of Safety and Effectiveness February 2006
- Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
- Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs
- Proposed Proprietary Trade Name: BASIS™ Spinal System II.
- Classification Name(s)/Product Code(s): 888.3050, 888.3060, 888.3070 III. Classification Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Pedicle Screw Spinal System Product Codes: KWQ, KWP, MNH, MNI
Product Description IV.
The BASISTM Spinal System consists of a variety of shapes and sizes of hooks, screws, bolts, nuts, plates, and vertebral body spacers, as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.
BASIS™ hooks are intended for posterior use only.
The BASIS™ Spinal System implant components are made from medical grade titanium alloy. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.
BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the BASIS™ Anterior Thoracolumbar Plate, the BASIS™ Multi-Axial Screws, or the BASIS™ Fixed Angle Screws must be used with the BASIS™ Vertebral Body Spacers.
To achieve best results, do not use any of the BASIS™ components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic implants, none of the BASIS™ components should ever be reused under any circumstances.
The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System.
1
Indications V.
The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., multations: Spondyformanons, washing (11), seudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS Except for noons, when asse the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be when assured as a versory oes to aid in surgical correction and stabilization of the spine. The device is used in corportion procedures would spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Danek BASIS™ Anterior Thoracolumbar Plates, Multi-Axial Screws, or Fixed Angle Screws. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.
Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Posterior surgical implantation. The BASIS™ Anterior Cervical Plates are intended for posici in burged intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only.
Substantial Equivalence VI.
VI. Components to be substantially equivalent to EQUATION™ Fixation System Components previously cleared in K013962.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve and converge at the bottom, resembling a stylized human figure. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.
FEB 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132
Re: K060081
: K060081
Trade/Device Name: BASIS™ Spinal System Frade/Don Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Regulatory - KWP, KWQ, MNH, MNI Dated: January 9, 2006 Received: January 10, 2006
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section > Iv(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device andrested in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally intarced teched as a discal Device Amendments, or to
commerce prior to May 28, 1976, the enactment with the provisions of the Fede commerce prior to May 28, 1976, the elacance with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of IMA) devices that have been reclassified in accordance whe are approval application (IPMA).
and Cosmetic Act (Act) that do not require approval applications of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contra You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requiret mishranding and general controls provisions of the Act merade requirement.
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 If your device is classified (see aove) nito existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additions. Existing mays regal to 898 In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addion, FDA ma be found in the Code of Federal Regarders in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substitition with other requirements of the Act
that FDA has made a determination that your device addres accepcies. You must that FDA has made a determination mac your arrest by other Federal agencies. You must or any Federal statutes and regulations and united to: registration and listing (21
comply with all the Act's requirements, and comply with all the Act S requirements, merdamg, out her mintenents as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Richard W. Treharne, PhD
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1650. product Taulation control provisions (Decisions (Device as described in your Section 5 10(k) I ms letter will anow you to ocgin manuting of substantial equivalence of your device to a legally premarket nother in the PDA midning of backman of the evice 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 advice for Jour ac 10-10-20120. Also, please note the regulation entitled, a Colliact the Office of Complance an (21 t notification" (21CFR Part 807.97). You may obtain Misolanding by relevelee to promantonionship.itities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-204 to Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sor Mark N. Melkerson
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of ____________________________________________________________________________________________________________________________________________________________________ February 2006
510(k) Number (if known):
BASISTM Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use
The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; survatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, EXCEpt for noons, when used as an atter following indications: (1) spinal stenosis, (2) BASIS components are monded for the formities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to when used as a vertebrar body replaceming surgical correction and stabilization of the spine. The be used in corpectonly procedures to the under spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Specifically, DASID - Vertenal Booy of lates, Multi-Axial Screws, or Fixed Angle Screws. Dallek DASIS - Amerior Theraceral Body Spacers are intended to be used with bone graft.
Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Nota Denc. The Drive - The BASIS™ Anterior Cervical Plates are intended for anterior cervical intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only.
X 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
510(k) Number K060081
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