(101 days)
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
No
The summary describes a mechanical spinal implant and its intended use, materials, and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a spinal implant intended to replace a damaged vertebral body, restoring biomechanical integrity and being used for trauma (fracture) or tumor, which are therapeutic interventions.
No
This device is a spinal implant intended for vertebral body replacement, which is a therapeutic function, not a diagnostic one. It is used to replace a damaged or unstable vertebral body due to tumor or trauma.
No
The device description explicitly states the device is a "vertebral body replacement device fabricated from titanium," indicating it is a physical implant, 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 description clearly states that the XYcor™ Spinal Implant is a "vertebral body replacement device" intended for surgical implantation in the spine to replace damaged or removed vertebrae. This is a device used within the body for structural support and restoration.
The information provided about the device's mechanical testing, intended use in surgery, and comparison to other spinal implants further confirms its nature as an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant 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.
The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.
Product codes (comma separated list FDA assigned to the subject device)
MOD, MQP
Device Description
The XYcor™ Spinal Implant is a vertebral body replacement device fabricated from titanium. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XY cor™ Spinal Implant prior to deployment is of comparable size and shape to the DEVEX™ System and, after deployment, is of comparable size to the InFix® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (T3-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was performed on the XY cor™ Spinal Implant and the results are presented. The XYcor™ Spinal Implant demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.
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
5. 510(k) Summary as required by 21 CFR 807.92(c)
| 510(k) Owner: | Vertebration, Inc.
3375 Brentwood Court
Powell, OH 43065
Phone: (614) 437-2027
Facsimile: (614) 437-2034 | APR 20 2007 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact person: | Barbara S. Fant, Pharm.D.
Clinical Research Consultants, Inc.
310 Terrace Avenue
Suite 201
Cincinnati, OH 45220
Phone: (513) 961-8200
Facsimile: (513) 961-2858 | |
| Date: | January 5, 2007 | |
| Trade Name: | XYcorTM Spinal Implant for Minimally Invasive Spinal Surgery | |
| Common name: | Vertebral body replacement device | |
| Classification Name: | Spinal Intervertebral body fixation orthosis
21 CFR 888.3060 | |
| Product Code: | MOD | |
Identification of a Legally Marketed Predicate Device
The XY cor™ Spinal Implant is substantially equivalent to the InFix® System marketed by Abbott Spine, 510(k) Premarket Notification Number: K031672, FDA Product Code MQP. Secondly, it is substantially equivalent to the SYNEX™ System manufactured by Synthes Spine, 510(k) Premarket Notification Number: K003836, FDA Product Code MQP; and, to the DEVEX™ System manufactured by DePuy Spine; 510(k) Premarket Notification Number: K023835, FDA Product Code MQP.
General Description
The XYcor™ Spinal Implant is a vertebral body replacement device fabricated from titanium. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XY cor™ Spinal Implant prior to deployment is of comparable size and shape to the DEVEX™ System and, after deployment, is of comparable size to the InFix® System.
Vertebration, Inc. Proprietary and Confidential Information
1
Intended Use
The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant 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.
The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.
Performance Data
Mechanical testing was performed on the XY cor™ Spinal Implant and the results are presented. The XYcor™ Spinal Implant demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.
Basis of Substantial Equivalence
The XYcor™ Spinal Implant is substantially equivalent to INFIX® System manufactured by Abbott Spine under 510(k) Premarket Notification Number K010530, FDA Product Code MQP, and regulation 21CFR888.3060 (spinal intervertebral body fixation orthosis) in material, intended use, basic design concept, size of the footprint, and biomechanical properties. Secondly, it is also substantially equivalent to the SYNEX™ Spacer System manufactured by Synthes Spine under 510(k) Premarket Notification Number K003836, FDA Product Code MQP, and regulation 21CFR&888.3060 (spinal intervertebral body fixation orthosis) in its self-locking mechanism after distraction, and to the DEVEX ™ System manufactured by DePuy Spine under 510(k) Premarket Notification Number K023835, FDA Product Code MQP, and regulation 21CFR§888.3060 (spinal intervertebral body fixation orthosis) in its shape prior to deployment and the posterior approach used in surgical placement.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
APR 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vertebration Incorporated c/o Dr. Barbara Fant 310 Terrace Avenue - Suite 201 Cinncinnati, Ohio 45220
Re: K070082
Trade Name: XYcor™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 19, 2007 Received: March 21, 2007
Dear Dr. Fant:
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 – Dr. Barbara Fant
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Mellekson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
510(k) Number (if known): K070082
Device Name: XYcor™ Spinal Implant
Indications for Use:
.
The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XY cor™ Spinal implant 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.
The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ Spinal Implant include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED . 18 A
| Concurrence of CDRH, Office of Device Evaluation/ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| Prescription Use X | |
| 510(k) Number | K070082 Over-The-Counter Use |
| Vertebration Inc. |
oration, Inc. Proprietary and Confidential Information
1/08/2007