(108 days)
Not Found
No
The summary describes a physical implantable device (intervertebral body fusion device/vertebral body replacement) made of PEEK, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
Explanation: The device is indicated for use in surgical procedures to treat conditions like degenerative disc disease and vertebral body instability due to tumor or trauma to restore biomechanical integrity and facilitate fusion in the spine, which are therapeutic medical interventions.
No
The description explicitly states that the Vu ePOD and Vu LPOD are intervertebral body fusion devices and vertebral body replacement systems, intended to replace body parts (e.g., collapsed vertebral bodies) and restore biomechanical integrity, not to diagnose medical conditions.
No
The device description explicitly states it is comprised of PEEK OPTIMA-LT cages, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to fuse vertebrae or replace vertebral bodies. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics of a surgical cage made of PEEK, designed for implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. The device's function is purely mechanical support and facilitation of fusion.
- Performance Studies: The performance studies focus on mechanical properties and structural integrity, which are relevant for surgical implants, not diagnostic tests.
Therefore, the Vu ePOD and Vu LPOD devices are surgical implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
When used as a vertebral body replacement (VBR) the Vu ePOD and Vu LPOD VBR System 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 ePOD and Vu LPOD VBR System 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 device is indicated for use with autograft or allograft only.
The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are comprised of PEEK OPTIMA-LT cages with fenestrations and radii on all sides and toothed ridges. The toothed ridges of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu ePOD is a straight shaped cage while the Vu LPOD has a curved shape. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices may be used individually or in a pair depending on the surgical need.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1, thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature
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 of the subject device consisted of static axial compression, static compression shear, dynamic axial compression, dynamic compression shear, subsidence and expulsion. Testing was conducted in accordance with ASTM F-2077 and ASTM F-2267. The construct performed as designed and met or exceeded all product specifications.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
510(k) Summary (21 CFR Part 807.92)
Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices
MAX 888.3080 (Class II) - Intervertebral body fusion device
Theken Surgical REVEAL VBR System, K050058
Theken Spine Vu ePOD System, K071031 Theken Spine Vu aPOD System, K080822
MQP 888.3060 (Class II) - Spinal intervertebral body fixation orthosis
Intervertebral body fusion device
A. Submitter Information
| Submitter's Name: | Theken Spine, LLC |
|---|---|
| Establishment Registration #: | 1530901 |
| Address: | 1800 Triplett Blvd. Akron, Ohio 44306 |
| Telephone Number: | 330-475-8600 |
| Fax Number: | 330-773-7697 |
| Contact Person: | Dale Davison |
| Date Prepared: | 9/12/2008 |
JAN - 2 2009
B. Device Information
Trade Name:
Common Name:
Classification:
Predicate Devices:
Device Description:
Summary of Test Data:
Intended Use:
The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are comprised of PEEK OPTIMA-LT cages with fenestrations and radii on all sides and toothed ridges. The toothed ridges of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu ePOD is a straight shaped cage while the Vu LPOD has a curved shape. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices may be used individually or in a pair depending on the surgical need.
Mechanical testing of the subject device consisted of static axial compression, static compression shear, dynamic axial compression, dynamic compression shear, subsidence and expulsion. Testing was conducted in accordance with ASTM F-2077 and ASTM F-2267. The construct performed as designed and met or exceeded all product specifications.
When used as an intervertebral body fusion device the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
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When used as a vertebral body replacement (VBR) the Vu ePOD and Vu LPOD VBR System 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 ePOD and Vu LPOD VBR System 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 device is indicated for use with autograft or allograft only.
The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.
C. Substantial Equivalence
The technological characteristics of the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are similar to the predicate device REVEAL Vertebral Body Replacement (K050058), the Theken Spine Vu ePOD System (K071031) and the Theken Spine Vu aPOD System (K080822).
The subject device similarities include:
- The same indications for use as the Vu aPOD �
- The same basic design as the Vu ePOD and Vu LPOD .
- The same operating principle
- The same materials
- Used in conjunction with 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 ePOD and Vu LPOD Intervertebral Body Fusion Devices are substantially equivalent to the predicate device REVEAL Vertebral Body Replacement (K050058), the Theken Spine Vu ePOD System (K071031) and the Theken Spine Vu aPOD System (K080822). 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 represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. 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. The logo is simple, using a black and white color scheme.
Public Health Service
Food and Drug. Administration 9200 Corporate Boulevard Rockville MD. 20850
Theken Spine, LLC % Mr. Dale Davison 1800 Triplett Blvd Akron, OH 44306
JAN - 2 2009
Re: K082712
Trade/Device Name: Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX, MQP Dated: December 30, 2008 Received: December 31, 2008
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.
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 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/cdrl/industry/support/index.html.
Sincerely yours.
Mark M. Milliman
- 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): K082712
Device Name: Theken Spine Vu ePOD and Vu LPOD System
Indications for Use:
When used as an intervertebral body fusion device, the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
When used as a vertebral body replacement (VBR) the Vu ePOD and Vu LPOD VBR System 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 ePOD and Vu LPOD VBR System 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 device is indicated for use with autograft or allograft only.
The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
MARYANN H. LLOYD FOR M.MELKERSON
Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082712
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