(170 days)
No
The document describes a physical implantable device for spinal stabilization and fusion, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as an internal fixation device intended for holding bone parts in alignment while they heal and to promote intervertebral body fusion. This indicates a structural and supportive function rather than an active therapeutic action.
No
The device is an implantable surgical device designed to provide stabilization and promote fusion between vertebral bodies. Its purpose is therapeutic (alignment and healing of bone parts), not diagnostic.
No
The device description clearly states it consists of physical components (CoCrMo spheres) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Spinal Stabilizing Sphere System is an implantable internal fixation device inserted between vertebral bodies to provide stabilization and promote fusion. This is a surgical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Spinal Stabilizing Sphere System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Spinal Stabilizing 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. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.
Product codes
NVR
Device Description
The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full and trimmed), which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc space from 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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Harmon Spinal Sphere- Preamendment (Austenal Company), Fernstrom SKF Ball- Preamendment (unknown), Satellite™ Spinal System- K051320 (Medtronic Sofamor Danek)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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K063139
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Image /page/1/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is written in a bold, sans-serif font with a unique design where the letters are interconnected and partially enclosed in rectangular shapes. Below "BIOMET", the words "ORTHOPEDICS, INC." are written in a smaller, simpler sans-serif font.
510(k) Summary
Preparation Date: October 13, 2006
Applicant/Sponsor: Biomet Spine
Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist
Proprietary Name: Spinal Stabilizing Sphere System
Common Name: Spinal Sphere
Unclassified - NVR (preamendment device) Classification Name:
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Harmon Spinal Sphere- Preamendment (Austenal Company); Fernstrom SKF Ball- Preamendment (unknown); Satellite™ Spinal System- K051320 (Medtronic Sofamor Danek)
Device Description: The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full and trimmed), which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
Intended Use: The Spinal Stabilizing 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. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.
Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Spinal Stabilizing Sphere System are similar to or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except for Satellite™ (Medtronic Sofamor Danek)
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
D
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 574.267.6639
574.207.8137
E-MAIL biomet@biomet.com
APR - 4 2007
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corporation c/o Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
APR - 4 2007
Re: K063139
Trade/Device Name: Spinal Stabilizing Sphere System Regulatory Class: Unclassified Product Code: NVR Dated: March 26, 2007 Received: March 27, 2007
Dear Ms. Sandborn Beres:
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 - Ms. Patricia Sandborn Beres
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,
Miriam C. Provost
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO 63139 510(k) Number (if known):
Device Name: Spinal Stabilizing Sphere System
Indications For Use:
The Spinal Stabilizing 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. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063139
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