BASIS SPINAL SYSTEM
K050484 · Medtronic Sofamor Danek, Inc. · KWP · May 4, 2005 · Orthopedic
Device Facts
| Record ID | K050484 |
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| Device Name | BASIS SPINAL SYSTEM |
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| Applicant | Medtronic Sofamor Danek, Inc. |
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| Product Code | KWP · Orthopedic |
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| Decision Date | May 4, 2005 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 888.3050 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended 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. 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.
Device Story
BASIS Spinal System is a spinal fixation implant set comprising titanium/titanium alloy hooks, screws, and rods. Used by surgeons in clinical settings to stabilize the spine; components are rigidly locked into patient-specific configurations to address spinal pathologies including stenosis, deformity, and trauma. System provides mechanical support to facilitate fusion or stabilization. No software or electronic components involved.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Materials: medical grade titanium and titanium alloy. Components: hooks, screws, rods. Configuration: rigid locking mechanism. Energy source: none (mechanical). Connectivity: none. Sterilization: not specified.
Indications for Use
Indicated for patients requiring spinal fixation for spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), trauma (fracture/dislocation), pseudarthrosis, tumor, or failed previous fusion. Posterior, non-cervical use for screws/hooks; anterolateral thoracic/lumbar or anterior cervical use for other components (excluding hooks).
Regulatory Classification
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.
Predicate Devices
- CD HORIZON Spinal System (K042025)
- CD HORIZON Spinal System (K020709)
- CD HORIZON Spinal System (K981676)
Related Devices
- K060081 — BASIS SPINAL SYSTEM · Medtronic Sofamor Danek · Feb 13, 2006
- K071905 — POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) · Lanx, LLC · Dec 28, 2007
- K111457 — CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek · Sep 15, 2011
- K072339 — NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM · Nuvasive, Inc. · Oct 19, 2007
- K980484 — AESCULAP SPINE SYSTEM EVOLUTION · Aesculap, Inc. · Oct 2, 1998
Submission Summary (Full Text)
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# 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.
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### 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).
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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
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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
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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_________________________________________________________________________________________________________________________________________________________________
