(117 days)
Not Found
No
The summary describes a physical implantable device (spinal spheres) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an orthopedic implant designed to promote intervertebral body fusion and provide stabilization, acting as an internal fixation device. While it aids healing, it is not described as providing therapy or treatment in the traditional sense of a therapeutic device (e.g., pain relief, disease treatment beyond mechanical support).
No
The device is an implantable system designed to provide stabilization and promote intervertebral body fusion, not to diagnose a condition.
No
The device description clearly states the device consists of physical spheres manufactured from CoCrMo or PEEK-OPTIMA, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Spinal Sphere System Function: The description clearly states the Spinal Sphere System is an implantable device intended to be inserted between vertebral bodies to provide stabilization and promote fusion. It is a physical device used within the body, not for testing samples outside the body.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Spinal Sphere 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. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.
Product codes (comma separated list FDA assigned to the subject device)
NVR
Device Description
The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK-OPTIMA. The device may be implanted from L3 to S1 to provide temporary stabilization in order to help promote fusion. The spheres are available in a variety of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L3 to S1
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)
Not Found
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.
Satellite™ Spinal System (Medtronic Sofamor Danek, K051320 and K060415)
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.
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
N/A
0
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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073274
510(k) Summary
MAR 1 7 2008
| 510(k) Summary - Spinal Sphere System | |
|---|---|
| Preparation Date: | November 20, 2007 |
| Submitted By: | Life Spine |
| 2401 W. Hassell Road, Suite 1535 | |
| Hoffman Estates, IL 60169 | |
| Telephone: 847-884-6117 | |
| Fax: 847-884-6118 | |
| Contact: | Rebecca M. Brooks |
| Life Spine | |
| 2401 W. Hassell Road, Suite 1535 | |
| Hoffman Estates, IL 60169 | |
| Telephone: 847-884-6117 | |
| Fax: 847-884-6118 | |
| Proprietary Trade Name: | Spinal Sphere System |
| Classification Name: | Intervertebral Fusion Device With Bone Graft, Solid- |
| Sphere, Lumbar | |
| Product Code: | NVR |
| Predicate Device: | Satellite™ Spinal System (Medtronic Sofamor Danek, |
| K051320 and K060415) |
Device Description:
The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK-OPTIMA. The device may be implanted from L3 to S1 to provide temporary stabilization in order to help promote fusion. The spheres are available in a variety of sizes.
Intended Use of the Device:
The Spinal Sphere 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. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.
Substantial Equivalence:
The Spinal Sphere System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Life Spine % Rebecca M. Brooks Project Coordinator 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169
MAR 1 7 2008
K073274 Trade/Device Name: Spinal Sphere System Regulation Number: Pre-amendment Regulation Name: N/A Regulatory Class: Unclassified Product Code: NVR Dated: February 28, 2008 Received: February 29, 2008
Dear Ms. Brooks:
Re:
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, of a similar point size, and in bold print:
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 - Ms. Rebecca M. Brooks
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
VCGILL
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ 0732 74
Device Name: Spinal Sphere System
The Spinal Sphere 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. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.
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)
Neil R.P. Oyler fix mem
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073274