(228 days)
Not Found
No
The summary describes a physical implant made of PEEK for spinal surgery and makes no mention of AI or ML technology.
Yes
The device is indicated for partial replacement of a diseased or fractured vertebral body to decompress the spinal cord and restore height, which are therapeutic interventions.
No
The device is indicated for partial replacement of a diseased vertebral body and treatment of fractures, aiming to restore height and biomechanical integrity of the spinal column. This describes a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly states the device is comprised of polyetheretherketone (PEEK), which is a physical material, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace parts of the vertebral body in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is made of PEEK and is a physical implant. IVDs are typically reagents, kits, or instruments used to analyze samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples or provide diagnostic information. Its function is structural support and replacement.
Therefore, the Small Stature Spacers are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Product codes (comma separated list FDA assigned to the subject device)
MOP
Device Description
The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI ESL PEEK-OPTIMA® Spine System cleared in K061016.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1 to L5), thoracic and lumbar spine, anterior, middle and posterior spinal column
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(k) Summary
Preparation Date: November 8, 2006 JUN 2 5 2007
Applicant/Sponsor: Biomet Spine
Contact Person: Debra L. Bing
Proprietary Name: Small Stature Spacers
Common Name: Vertebral Body Replacement Device
Classification Code/Name: Spinal Intervertebral Fixation Orthosis, 21 CFR 8888.3060
Product Code: MOP
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- ESL® PEEK-OPTIMA® Spine System K061016 .
Device Description:
The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI ESL PEEK-OPTIMA® Spine System cleared in K061016.
Indications for Use:
The Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Summary of Technologies: The technological characteristics of the Small Stature Spacers are the same as, or similar to, the predicate device.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.
All trademarks are property of Biomet, Inc., except PEEK-OPTIMA®, which is the property of Invibio Biomaterial Solutions.
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Image /page/1/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Spine % Biomet Manufacturing Corporation Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K063393
Trade/Device Name: Small Stature Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 18, 2007 Received: May 21, 2007
Dear Ms. Alexander:
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.
2
Page 2 - Ms. Susan Alexander
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 marketed predicate device 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Harbazo Muchup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K063393 510(k) Number (if known):
Device Name: Small Stature Spacers
Indications For Use:
The Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Prescription Use YES (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)
Qabare Buerup
(Division Sign-Of Division of General, Restorative, and Neurological Devices
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510(k) Number K063393