(98 days)
The x•POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).
The x•POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.
The x•POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).
The x•POD Adjustable Vertebral Body Replacement is comprised of a cylindrical titanium (Ti-6Al-4V) mechanism with rectangular endplates. The system has fenestrations axially and laterally to maximize bone graft placement. The implants are manufactured in a variety of geometric combinations to better fit each patient's pathology. The anatomically designed endplates are designed to minimize expulsion and rotation of the implant postoperatively. The x•POD Adjustable Vertebral Body Replacement is manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 standards. The x•POD Adjustable Vertebral Body Replacement construct is used individually and is always implanted with the construct oriented vertically.
This is a 510(k) premarket notification for a spinal implant device (x•POD Adjustable Vertebral Body Replacement), not a diagnostic AI device. Therefore, the provided text does not contain information about acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the approval process for this type of medical device.
The approval is based on "substantial equivalence" to legally marketed predicate devices, meaning it has similar intended use, design, and physical characteristics, and performs comparably in mechanical testing, not through clinical performance metrics like sensitivity or specificity.
Therefore, I cannot provide the requested information.
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K070786
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510(k) Summary (21 CFR Part 807.92)
Submitter Information A..
JUN 2 8 2007 Theken Spine, LLC Submitter's Name: 283 E. Waterloo Address: Akron, Ohio 44319 Telephone Number: 330-773-7677 x221 330-773-7697 Fax Number: Dale Davison Contact Person: 15 March 2007 Date Prepared: Device Information B. x•POD Adjustable Vertebral Body Replacement Trade Name: Vertebral Body Replacement Device Common Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR Classification Name: 888.3060) Class II (per 21 CFR 888.3060) Device Classification: Panel: Orthopedic, Product Code: MQP, Panel Code: 87 Theken Surgical, LLC-Reveal VBR System (K050058) Predicate Device: Osteotech, Inc. - VBR (K003155) Osteotech, Inc. - VBR (K012254) Synthes (USA) - Synex Spacer System Titanium Alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3 Material Composition: The x•POD Adjustable Vertebral Bodv Replacement Device Description: is comprised of a cylindrical titanium (Ti-6Al-4V) mechanism with rectangular endplates. The system has fenestrations axially and laterally to maximize bone graft placement. The implants are manufactured in a variety of geometric combinations to better fit each patient's pathology. The anatomically designed endplates are designed to minimize expulsion and rotation of the implant postoperatively. The x·POD Adjustable Vertebral Body Replacement ાં ર manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 standards. The x•POD Adjustable Vertebral Body Replacement construct is used individually and is always implanted with the construct oriented vertically.
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Intended Use:
The x•POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).
The x•POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.
The x•POD Adiustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).
C. Substantial Equivalence
The technological characteristics of the x-POD Adjustable Vertebral Body Replacement are similar to the following predicate devices:
REVEAL VBR System manufactured by Theken Spine, LLC (K050058, SE 05/17/05). VBRTM manufactured by Osteotech, Inc (K003155, SE 01/04/2001). VBR™ manufactured by Osteotech, Inc (K012254, SE 11/16/2001). Synex Spacer System manufactured by Synthes (USA) (K003836, SE 05/29/2001).
Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have the same precautions and contraindications for use, and have the same potential for complications. Based on the design concept, the use of established materials, mechanical testing, indications for use, pre-production quality assurance planning and engineering andysis, Theken Spine believes that the x.POD Adjustable Vertebral Body Replacement is substantially equivalent to existing legally marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 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 body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Theken Spine % Mr. Dale Davison Vice President of Engineering 283 East Waterloo Road Akron, Ohio 44319
JUN 2 8 2007
Re: K070786
Trade/Device Name: x•POD Adjustable Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 21, 2007 Received: May 22, 2007
Dear Mr. Davison:
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.
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Page 2 – Mr. Dale Davison
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Radiological Health
Sincerely yours.
Enclosure
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Indications for Use
510(k) Number (if known): ___K070786
Device Name: x•POD Adjustable Vertebral Body Replacement
Indications For Use:
The x·POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).
The x·POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.
The x·POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number: /2070786
Page 1 of 1 -
N/A