(110 days)
No
The 510(k) summary describes a mechanical vertebral body replacement device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "Vertebral Body Replacement" indicated to "replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma" and "restore the biomechanical integrity" of the spinal column, which are therapeutic actions.
No
The device is a vertebral body replacement, indicated for surgical implantation to restore spinal integrity, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of physical components (PEEK concave cages, titanium spacer) intended for surgical implantation, indicating it is a hardware medical device.
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 designed to replace a vertebral body in the spine. This is a therapeutic device used in vivo (within the body), not a diagnostic device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description details the physical components of the implant (cages, spacer, spikes) and how they function mechanically within the spine. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Vu e.POD Vertebral Body Replacement is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vu e.POD 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 (ie. fracture).
The Vu e.POD 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. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.
The Vu e.POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical. LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).
Product codes
MQP
Device Description
The Vu e•POD Vertebral Body Replacement is comprised of PEEK concave cages with fenestrations and radii on all sides and toothed spikes used in combination with a titanium spacer component. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu e•POD Vertebral Body Replacement may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the construct oriented vertically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Theken Surgical, LLC CPOD/LPOD VBR System (K032064), Theken Surgical, LLC REVEAL VBR System (K050058)
Reference Device(s)
Theken Surgical, LLC, BodyForm Thoracolumbar Fixation System (K983622), Theken Surgical, LLC, Coral Spinal System (K041592)
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
Vu e•POD Vertebral Body Replacement
K07/031
4/9/2007
| | 510(k) Summary
(21 CFR Part 807.92) |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. Submitter Information | |
| Submitter's Name:
Address: | Theken Spine, LLC
283 E. Waterloo
Akron, Ohio 44319 |
| Telephone Number:
Fax Number:
Contact Person:
Date Prepared: | 330-773-7677 x221
330-773-7697
Dale Davison
4/9/07
JUL 30 2007 |
| B. Device Information | |
| Trade Name: | Vu e•POD Vertebral Body Replacement (VBR) System |
| Common Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (per 21 CFR
888.3060) |
| Device Classification: | Class II (per 21 CFR 888.3060)
Panel: Orthopedic, Product Code: MQP, Panel Code: 87 |
| Predicate Device: | Theken Surgical, LLC CPOD/LPOD VBR System (K032064)
Theken Surgical, LLC REVEAL VBR System (K050058) |
| Material Composition: | Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026
Tantalum per ASTM F-560
Titanium 6Al-4V ELI per ASTM F-136 |
| Subject Device Description: | The Vu e•POD Vertebral Body Replacement is comprised of
PEEK concave cages with fenestrations and radii on all sides and
toothed spikes used in combination with a titanium spacer
component. The cages and spacer can be locked together into a
variety of geometric configurations to fit each individual patient's
pathology. The toothed spikes of the concave cages engage with
the superior and inferior end plates of the neighboring vertebral
bodies to resist rotation and migration. The Vu e•POD Vertebral
Body Replacement may be used individually or in a pair depending
on the surgical need, however, the device is always implanted with
the construct oriented vertically. |
| Intended Use: | The Vu e•POD Vertebral Body Replacement is indicated for use in
the thoracolumbar spine (T1-L5) to replace a collapsed, damaged,
or unstable vertebral body due to tumor or trauma (e.g., fracture). |
| | The Vu e•POD 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.
Bone graft material is recommended to be packed into the interior
openings of the device prior to implantation. |
| | The Theken Vu e•POD Vertebral Body Replacement is intended to
be used with supplemental internal spinal fixation systems, such as
the Theken Surgical, LLC, BodyForm Thoracolumbar Fixation |
:
1
System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).
C. Substantial Equivalence
The technological characteristics of the Vu e•POD Vertebral Body Replacement are similar to the predicate device CPOD / LPOD Vertebral Body Replacement System (K032064), manufactured by Theken Surgical, LLC and cleared by the FDA on February 20, 2004 and REVEAL Vertebral Body Replacement, (K050058), Manufactured by Theken Surgical, LLC and clear by the FDA on May 17, 2005
The subject device similarities include:
- . The same indications for use
- . The same basic design
- . The same operating principle
- . The same materials
- Implanted using the same surgical techniques and equipment type ●
- . Used in conjunction with the same supplemental fixation
- The same manufacturing environment .
- . The same sterilization process
- The same packaging configurations .
Theken Spine believes that sufficient evidence exists to reasonably conclude that the Vu e.POD Vertebral Body Replacement is substantially equivalent to the predicate device REVEAL Vertebral Body Replacement (K050058), manufactured by Theken Surgical, LLC and cleared by the FDA on May 17, 2005. This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis. All implants are used to treat the same conditions, have the same precautions and contraindications for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.
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 depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and white. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Theken Spine, LLC % Mr. Dale Davison 283 East Waterloo Road Akron, Ohio 44319
JUL 3 0 2007
Re: K071031
Trade/Device Name: Vu e•POD Vetebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 10, 2007 Received: April 11, 2007
Dear Mr. Dale 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.
3
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 p vrheted 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/cdrb/industry/support/index.html.
Sincerely yours,
Kabara Buchup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO7103)
Device Name: Vu e.POD Vetebral Body Replacement
Indications For Use:
The Vu e.POD 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 (ie. fracture).
The Vu e.POD 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. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.
The Vu e.POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical. LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
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)
Harbare Buchw
Division of General, Restorative, and Neurological Devices
510(k) Number K07103
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