SATELLITE SPINAL SYSTEM
Device Facts
| Record ID | K051320 |
|---|---|
| Device Name | SATELLITE SPINAL SYSTEM |
| Applicant | Medtronic Sofamor Danek |
| Product Code | NVR · OR |
| Decision Date | Sep 9, 2005 |
| Decision | SESU |
| Submission Type | Traditional |
| Device Class | Class 3 |
| Attributes | Therapeutic |
Indications for Use
The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
Device Story
SATELLITE™ Spinal System consists of cobalt chrome spheres; implanted into disc space between L3-S1 vertebrae. Device provides temporary stabilization to facilitate intervertebral body fusion; used in conjunction with bone graft. Designed for surgical implantation by physicians to hold bone parts in alignment during healing process. Safety and effectiveness for motion-sparing or non-fusion procedures not established.
Technological Characteristics
Cobalt chrome spheres; internal fixation device; dimensions/form factor designed for intervertebral disc space insertion (L3-S1).
Indications for Use
Indicated for patients requiring stabilization and intervertebral body fusion at spinal levels L3-S1. Used as an internal fixation device to hold bone parts in alignment during healing in conjunction with bone graft.
Regulatory Classification
Identification
Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.
Predicate Devices
- Harmon Spinal Sphere (Austenal Company)
Submission Summary (Full Text)
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A final rule classifying spinal spheres for use in intervertebral fusion procedures, a preamendments, unclassified device type, into class III (premarket approval), was published on March 30, 2023. See here: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinalspheres-for-use-in-intervertebral-fusion. Concurrently, FDA published a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures. See here: https://www.federalregister.gov/documents/2023/03/30/2023-06565/effective-date-of-requirement-for-premarket-approvalapplications-for-spinal-spheres-for-use-in.
Please refer to the aforementioned final rule and final order for current regulatory requirements for this device type.
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## SATELLITE™ SPINAL SYSTEM 510(k) Summary - K051320 August 2005
| I. | Company: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, TN 38132<br>(901) 396-3133 | SEP - 9 2005 |
|----|----------|--------------------------------------------------------------------------------------|--------------|
| | Contact: | Richard W. Treharne<br>Sr. Vice President, Regulatory Affairs | |
- Proprietary Trade Name: SATELLITE™ Spinal System II.
- Classification Name: Spinal Device III.
- Regulation Number: Preamendment Device IV.
## Product Description V.
The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
## Indications VII
The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
## Substantial Equivalence VIII
- Documentation was provided which demonstrated the SATELLITE™ Spinal System to be substantially equivalent to a legally recognized preamendment device, namely the Harmon Spinal Sphere manufactured by the Austenal Company of New York, NY.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - U.S.A." are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2005
Richard W. Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
Re: K051320
Trade/Device Name: SATELLITE Spinal System Regulation Number: Pre-amendment Regulatory Class: Unclassified Product Code: NVR Dated: May 18, 2005 Received: May 20, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must be prominently displayed in all labeling, including pouch, box and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name:
The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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Page 2 - Richard W. Treharne, Ph.D.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K051320
Device Name: SATELLITE™ Spinal System
Indications for Use:
The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
Prescription Use X (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)
Mark A. Wilkerson
Division Sign-Off) Division of General, Restorative and Neurological Device
510(k) Number K051321
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