(216 days)
Not Found
No
The summary describes a physical implant and associated instrumentation for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for anterior cervical interbody fusion procedures in patients with cervical degenerative disc disease (DDD), which is a medical condition. It is used to treat a disease and improve patient health, fitting the definition of a therapeutic device.
No
This device is an intervertebral body fusion device, which is an implant used for surgical treatment, not for diagnosing a condition.
No
The device description explicitly states that the device consists of physical implants (spacers made from PEEK and tantalum) and instrumentation for implantation. This indicates it is a hardware device, not software-only.
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 for spinal fusion, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as an interbody fusion device made of PEEK polymer and tantalum, designed for surgical implantation. This is consistent with a medical device used in surgery, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies mentioned are related to the mechanical properties and stability of the implant (compression, shear, torsion, expulsion, subsidence), which are relevant for a surgical device, not an IVD.
Therefore, the Vu c POD Intervertebral Body Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c·POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.
Product codes
ODP
Device Description
The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu c POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (C2-C3 to C7-T1 disc levels)
Indicated Patient Age Range
skeletally mature patients
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
Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu crPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K082801, K081614, K080588, K091088, K072981, K091873
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KIO13G3
DEC 1 6 2010
510(k) Summary
| Manufacturer: | Theken Spine, LLC
1800 Triplett Blvd
Akron, OH 44306 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Theken Spine Vu c•POD Intervertebral Body Fusion Device |
| Contact: | Glenn Stiegman
Vice President, Regulatory Affairs
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
Office: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | November 24, 2010 |
| Classification: | §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Code: | ODP |
Indications For Use:
The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c·POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.
Device Description:
The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu c POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
1
Predicate Device(s):
The Vu c POD Intervertebral Body Fusion Device was shown to be substantially equivalent to previously cleared devices, including the US Spine Phantom PLUS Cage System (K082801), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cervical Cage (K091088), Synthes Spine Zero-P Cervical Cage (K072981), and SpineArt Tryptik® Cervical Cage (K091873).
Summary of Technological Characteristics:
The Vu c POD Intervertebral Body Fusion Device, in comparison to relevant predicate devices, has been shown to have the same indications for use, design, material of manufacture, and function.
Performance Standards:
Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu crPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices.
Conclusion:
Sufficient information, including extensive testing, has been presented to demonstrate the Vu c POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices with the same indications, intended use, and technological features.
Pg 2 of 2
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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 depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Theken Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Glenn Stiegman Vice President, Regulatory Affairs 1331 H Street NW, 12th Floor Washington, District of Columbia 20005
DEC 1 6 2010
Re: K101363
1
Trade/Device Name: Vu c.POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 02, 2010 Received: December 03, 2010
Dear Mr. Stiegman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Mr. Glenn Stiegman
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); 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. Milkus
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K101363
Device Name: Integra Spine Vu coPOD Intervertebral Body Fusion Device
The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Integra Spine Manta Ray or the Integra Spine Tether systems.
V Prescription Use (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millhusan
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K10/363