(135 days)
Not Found
No
The summary describes a mechanical spinal implant made of titanium and its intended use and mechanical testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma and restore biomechanical integrity, which are therapeutic actions.
No
The device is described as a "vertebral body replacement device" and an "intervertebral body fusion device," indicating its function is therapeutic (replacement/fusion) rather than diagnostic.
No
The device description explicitly states it is a spinal implant fabricated from titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the XYcor™ Spinal Implant is a vertebral body replacement device used in surgical procedures on the spine. It is a physical implant designed to restore structural integrity.
- Device Description: The device is described as a spinal implant fabricated from titanium. This is a physical medical device, not a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Focus on Mechanical Properties: The performance studies described focus on mechanical testing (compressive, torsional loading, resistance to subsidence and expulsion), which are relevant to the physical function of an implant, not a diagnostic test.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The XYcor™ Spinal Implant is an in vivo (inside the body) device used for structural support.
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 XYcor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation for vertebral body replacement. The supplemental internal fixation systems that may be used with the XYcor™ 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 screwrod/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.
The XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).
Product codes
MOP, MQP
Device Description
The XY cor™ Spinal Implant is a spinal implant fabricated from titanium that can be used as a vertebral body replacement device or an intervertebral body fusion device. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XYcor™ Spinal Implant V2-25 before and after deployment is of comparable size and shape to the other sizes of the XY cor™ implant.
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 V2-25 and the results are presented. The XYcor™ Spinal Implant V2-25 demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. Mechanical testing performed on the XY cor™ Spinal Implant supports its use as a vertebral body replacement device.. 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)
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
JAN - 9 2009
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
Contact person:
Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 (513) 961-8200 Phone: Facsimile: (513) 961-2858
August 22, 2008 Date:
XY cor™ Spinal Implant for Minimally Invasive Spinal Surgery Trade Name:
Vertebral body replacement device Common name:
Classification Name: Spinal Intervertebral body fixation orthosis 21 CFR 888.3060,
Product Code: MOP
Identification of a Legally Marketed Predicate Device
As a Vertebral Body Replacement Device, the XY cor™ Spinal Implant V2-25 small size is substantially equivalent to the XYcor™ standard and large sizes marketed by Vertebration, 510(k) Premarket Notification Number: K070082, FDA Product Code MQP.
General Description
The XY cor™ Spinal Implant is a spinal implant fabricated from titanium that can be used as a vertebral body replacement device or an intervertebral body fusion device. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XYcor™ Spinal Implant V2-25 before and after deployment is of comparable size and shape to the other sizes of the XY cor™ implant.
Intended Use
Page 1 of 2
1
The XYcor™ 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 XYcor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation for vertebral body replacement. The supplemental internal fixation systems that may be used with the XYcor™ 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 screwrod/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.
The XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).
Performance Data
Mechanical testing was performed on the XY cor™ Spinal Implant V2-25 and the results are presented. The XYcor™ Spinal Implant V2-25 demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. Mechanical testing performed on the XY cor™ Spinal Implant supports its use as a vertebral body replacement device.. The results did not raise any issues on the safety or effectiveness of the device.
Basis of Substantial Equivalence
The XY cor™ Spinal ImplantV2-25 is substantially equivalent to the other sizes of the XYcor™ Spinal Implant manufactured by Vertebration under 510(k) Premarket Notification Number K070082, FDA Product Code MQP, and regulation 21CFR§888.3060 (spinal intervertebral body fixation orthosis) in material, intended use, basic design concept, size of the footprint, and biomechanical properties.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three legs, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vertebration, Inc. % Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 310 Terrace Avenue, Suite 201 Cincinnati, OH 45220
Re: K082466
Trade/Device Name: XY cor Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 2, 2009 Received: January 5, 2009
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 - Barbara S. Fant, Pharm.D.
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 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 McMullen
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): K082466
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-LS) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectory procedures) due to tumor or trauma (i.e., fracture). The XY corPM Spinal implant is designed to restore the biomechanical integrity of the anterior, THC A respired to 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 for vertebral body replacement. The supplemental interpal fixation systems that may be used with the XY cor™ Spinal Implant include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fraation 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 smiling smi-rigid or flexible rod-screw systems.
The XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression deviaes, and posterior pedicle screw and rod systems).
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED .
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use
(Division Sign-Off)
Division of General, Restorati
Division of General, Restorative, and Neurological Devices
510(k) Number L082461