(68 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML terms.
No
The device is a partial vertebral body replacement, which is a structural implant for anatomical support rather than a device for treating a disease or condition.
No
The device is an implant designed to replace a resected or excised vertebral body, not to diagnose a condition.
No
The device description clearly indicates the ROI-T Implant is a physical, crescent-shaped block made of material intended for surgical implantation, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text describes a surgical implant (ROI-T Implant) that is placed inside the body to replace a vertebral body. It is a physical device used in a surgical procedure, not a test performed on a sample.
The information provided clearly indicates a surgical implant for spinal reconstruction, which falls under the category of implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ROI-T Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.
Product codes
MQP
Device Description
The ROI-T Implants are crescent shaped blocks in a variety heights and lordosis angles. The shape of the ROI-T offers more options to the surgeon to adapt to the patient' anatomy.
The ROI-T Implant features a closed graft space and offers superior vascularization of that space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5)
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
Finite Element Analysis results demonstrated that the proposed ROI-T Implant is substantially equivalent to the predicate device ..
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K080569
Page 1 of 2
Image /page/0/Picture/1 description: The image contains the logo "LDR" in bold, black font. To the right of the logo, there is some text in a smaller, lighter font that reads "o possion for anovation". The text is less clear than the logo, but it appears to be a tagline or slogan associated with the LDR brand.
MAY - 7 2008
510(k) Summary LDR Spine ROI-T Implant
1. Owner's Name & Address
LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
Phone: (512) 344-3333 (512) 344-3350 Fax:
2. Contact Person
Noah Bartsch, MS, RAC Manager, Clinical, Regulatory & Quality Affairs LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
Phone: (512) 344-3319 Fax: (512) 344-3350 Email: noahbartsch@ldrspine.com
-
- Date 510(k) Summary Prepared: February 27, 2008
| 4. | Trade Name: | LDR Spine ROI-T Implant |
|---|---|---|
| Common Name: | Spinal Partial Vertebral Body Replacement Device | |
| Classification: | MQP: Spinal Intervertebral Body Fixation Orthosis - Class II | |
| per 888.3060 |
6. Device Description
The ROI-T Implants are crescent shaped blocks in a variety heights and lordosis angles. The shape of the ROI-T offers more options to the surgeon to adapt to the patient' anatomy.
The ROI-T Implant features a closed graft space and offers superior vascularization of that space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.
1
7. Intended Use of the device
The ROI-T is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.
8. Non-Clinical Performance Data
Finite Element Analysis results demonstrated that the proposed ROI-T Implant is substantially equivalent to the predicate device ..
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2008
LDR Spine USA % Mr. Noah Bartsch, M.S., RAC Manager, Clinical, Regulatory and Quality Affairs 4030 West Braker Lane, Suite 360 Austin, TX 78759
Re: K080569
Trade/Device Name: LDR Spine ROI-T Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: April 17, 2008 Received: April 18, 2008
Dear Mr. Bartsch:
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.
3
Page 2 - Mr. Noah Bartsch, M.S., RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K080569
Page lot 1
Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name: LDR Spine ROI-T Implant
Indications for Use:
The ROI-T Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.
X Prescription Use (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. Ogden for MK
Division of General, Restorative. and Neurological Devices
510(k) Number K080569