(68 days)
Not Found
No
The 510(k) summary describes a system of mechanical implants (screws, hooks, rods) and instruments for spinal fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device, BASIS™ Spinal System, is intended for spinal fixation to treat various spinal conditions like stenosis, spondylolisthesis, and fractures, which directly alleviate or treat a disease/condition.
No
The device description clearly states that BASIS™ Screws and Hooks are used for posterior, non-cervical fixation and consist of implant components like hooks, screws, and rods, intended for surgical treatment of specified spinal conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the BASIS™ Spinal System consists of physical components like hooks, screws, and rods made from medical grade titanium and titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for posterior, non-cervical fixation and anterolateral thoracic/lumbar, or anterior cervical system for various spinal conditions. This involves surgical implantation and mechanical support of the spine.
- Device Description: The device is described as consisting of hooks, screws, and rods made from medical grade titanium and titanium alloy. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, analyzers, or test kits.
Therefore, the BASIS™ Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BASIS™ Screws and Hooks: The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.
BASIS™ Components: 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.
Product codes
KWP, KWQ, MNH, MNI
Device Description
The BASIS™ Spinal System consists of a variety of shapes and sizes of hooks, screws and rods as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. BASIS™ hooks are intended for posterior use only. The BASIS™ Spinal System implant components are made from medical grade titanium and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical, anterolateral thoracic/lumbar, anterior cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
MAY - 4 2005
BASISTM Spinal System Summary of Safety and Effectiveness April 2005
-
Medtronic Sofamor Danek, Inc. USA Company: I. 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): III. Classification Name: Spinal Interlaminal Fixation Orthosis, Pedicle Screw Spinal System, Spinal Intervertebral Body Fixation Orthosis (per 21 CFR Sections 888.3050, 888.3060, and 888.3070) Product Codes: KWP, KWQ, MNH, and MNI
IV. Product Description
The BASIS™ Spinal System consists of a variety of shapes and sizes of hooks, screws and rods as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
BASIS™ hooks are intended for posterior use only.
The BASIS™ Spinal System implant components are made from medical grade titanium and 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.
1
Indications V.
BASIS™ Screws and Hooks
The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; 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.
Substantial Equivalence VI.
Documentation was provided which demonstrated the BASIS™ Spinal System to be substantially equivalent to the following systems: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
MAY - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132
Re: K050484
Trade/Device Name: BASIS™ Spinal System Regulation Number: 21 CFR 888.3070, 888.3060, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MNI, KWQ, KWP, MNH Dated: February 22, 2005
Received: February 25, 2005
Dear Dr. Treharne:
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. 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
3
Page 2 – Mr. Richard W. Treharne
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse finding of substantial equivalence of your device to a legally premation in the 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 If you desire specific acrioliance at (240) 276-0120 . Also, please note the regulation entitled, connact the Ories of Compunition in (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Hypt Rlwdn
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1 April 2005
510(k) Number (K050484):
BASIS™ Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use
BASIS™ Screws and Hooks
Dribit - berews and Hooks are intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, the following indications: spinal stenesse, are -----------------------------------------------------------------------------------------------------------------------------and/or failed previous fusion.
BASIS™ Components
Except for hooks, when used as an anterolateral thoracic/lumbar, BASIS™ components Except for 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.
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)
Hytl Rurdes
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________