(100 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is used to treat degenerative disc disease and acts as an adjunct to fusion, directly addressing a medical condition.
No
Explanation: The device is an intervertebral body fusion device used as an adjunct to fusion for treating degenerative disc disease, not for diagnosing it. Its description focuses on its physical components and intended use in surgery, rather than diagnostic capabilities.
No
The device description clearly states it is comprised of PEEK-OPTIMA® LT cages and an optional titanium spin plate, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Theken Spine Vu aPOD Intervertebral Body Fusion Device is an implantable medical device designed to be surgically placed in the spine to aid in fusion. It is a physical structure, not a tool for analyzing biological samples.
- Intended Use: The intended use is to provide structural support and facilitate bone fusion in patients with degenerative disc disease. This is a therapeutic and structural function, not a diagnostic one.
The device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Theken Spine Vu aPOD Intervertebral Body Fusion Device is 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 interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is 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
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD
Device Description
The Vu aPOD Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which can be used in combination with an optional titanium spin plate. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
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)
Not Found
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.
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K080822 (pg. 1 of 2)
Theken Spine, LLC Vu aPOD Intervertebral Body Fusion Device
7/01/2008
(21 CFR Part 807.92)
| A. Submitter Information | JUL - 2 2008 |
|---|---|
| Submitter's Name: | |
| Address: | Theken Spine, LLC |
| 1800 Triplett Blvd. | |
| Akron, Ohio 44306 | |
| Telephone Number: | |
| Fax Number: | |
| Contact Person: | |
| Date Prepared: | 330-475-8600 |
| 330-773-7697 | |
| Dale Davison | |
| 7/01/2008 | |
| B. Device Information | |
| Trade Name: | Vu aPOD Intervertebral Body Fusion Device |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Spinal Intervertebral Body Fusion Device (per 21 CFR 888.3080) |
| Device Classification: | Class II (per 21 CFR 888.3080) |
| Panel: Orthopedic, Product Code: MAX | |
| Predicate Device: | Theken Surgical, LLC REVEAL VBR System (K050058) |
| DePuy Acromed Lumbar I/F Cage (P960025) | |
| Spinal Elements, Lucent Magnum (K073348) | |
| 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 aPOD Intervertebral Body Fusion Device is comprised of |
| PEEK-OPTIMA® LT cages which can be used in combination | |
| with an optional titanium spin plate. The cages include toothed | |
| spikes on the top and bottom surfaces to engage with the superior | |
| and inferior end plates of neighboring vertebral bodies to resist | |
| rotation and migration. The cage shape and open center allow for | |
| bony in-growth in and around the implant. A single cage is | |
| sufficient to be used at each intervertebral level. | |
| Intended Use: | The Theken Spine Vu aPOD Intervertebral Body Fusion Device is |
| 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 interior of the | |
| spacer component may be packed with autogenous bone graft | |
| material. The Theken Spine Vu aPOD Intervertebral Body Fusion | |
| Device is intended for use with supplemental fixation such as the | |
| Coral Spinal System or the BodyForm Thoracolumbar Fixation | |
| System. |
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K080822 (pg. 2 of 2)
Theken Spine, LLC Vu aPOD Intervertebral Body Fusion Device
C. Substantial Equivalence
The technological characteristics of the Vu aPOD Intervertebral Body Fusion Device are similar to the predicate device REVEAL Vertebral Body Replacement (K050058), Manufactured by Theken Surgical. LLC, the DePuy Acromed Lumbar IF Cage (P960025), and the Spinal Elements Lucent Magnum (K073348)
The subject device similarities include:
- Indications for use
- The same basic design ●
- . 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 aPOD Intervertebral Body Fusion Device is substantially equivalent to the predicate device REVEAL Vertebral Body Replacement (K050058), manufactured by Theken Surgical, LLC, the DePuy Acromed Lumbar VF Cage (P960025), and the Spinal Elements Lucent Magnum (K073348). 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with its wings spread, formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Theken Spine, LLC % Mr. Dale Davison 1800 Triplett Boulevard Akron, OH 44306
SEP 12 2011
Re: K080822
Trade/Device Name: Vu a·POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 15, 2008 Received: June 3, 2008
Dear Mr. Davison:
This letter corrects our substantially equivalent letter of July 2, 2008.
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 (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 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
3
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Mulhausen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):__K080822
Device Name: Vu aPOD Intervertebral Body Fusion Device
Indications For Use:
The Theken Spine Vu aPOD Intervertebral Body Fusion Device is 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 interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is 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
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number /Lo 80422
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