(30 days)
Not Found
No
The summary describes a passive implantable device made of titanium alloy for vertebral body replacement and fracture treatment. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for use in the thoracolumbar spine to replace a diseased vertebral body, achieve anterior decompression, restore height, and treat fractures, which are all therapeutic interventions designed to treat a medical condition.
No
The provided text describes the GEO Structure as a vertebral body replacement device used to treat spinal conditions like tumors and fractures. Its function is to replace diseased vertebral bodies, restore height, and maintain spinal integrity. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description explicitly states it is a vertebral body replacement device manufactured from titanium alloy, indicating it is a physical implant, not software.
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 vertebral bodies in the spine for structural support and decompression. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed within the body. This is consistent with a medical device, not an IVD which typically involves testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on in vitro testing.
Therefore, the GEO Structure is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) to replace 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 GEO structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure is 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)
MQP
Device Description
The GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.
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 LS)
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)
Data regarding the functional performance of the proposed GEO Structure has been generated and indicates that the proposed GEO Structure meets or exceeds all functional requirements and supports its suitability for use.
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.
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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).
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§ 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.
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510(k) SUMMARY
SUBMITTED BY
2/6/02
Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
January 4, 2002
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Vertebral Body Replacement Common/Usual Name: Vertebral Body Replacement Product Classification: Class II Proprietary Name: GEOTM Structure
PREDICATE DEVICE
The predicate device is the GEO™ Structure (K010530).
INDICATIONS-FOR-USE
The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) to replace a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GEO structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
DEVICE DESCRIPTION
The GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.
DISCUSSION OF NONCLINICAL TESTS
Data regarding the functional performance of the proposed GEO Structure has been generated and indicates that the proposed GEO Structure meets or exceeds all functional requirements and supports its suitability for use.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, with wavy lines below them. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the design, with "SERVICES" at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Ms. Lynn M. Rodarti Manager, Clinical and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K020048
Trade/Device Name: GEO™ Structure Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 4, 2002 Received: January 7, 2001
Dear Ms. Rodarti:
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.
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Page 2 - Ms. Lynn Rodarti
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
R. Martin Milken
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K 02 0048
Page 1 of 1
510(k) Number (if known):
GEO Structure Device Name:
Indications-For-Use:
The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) to replace 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 le admore a collapsed vertebral body. The GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure is designed to restore the biomechanical integrity of the anterior middle and posterior spinal column even in the absence of fusion for a prolonged period.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Millican
Division Sign-Off) (Division Sigi-Ori)
Division of General, Resions Divisiourological Devices 1620048
510(k) Number .
Prescription Use (PER 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-
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