(121 days)
No
The 510(k) summary describes a physical implant and surgical screws, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical properties and wear testing.
Yes
The device is intended for the treatment of cervical disc disease, which involves neck pain and disc degeneration, and is used to facilitate intervertebral body fusion. This clearly indicates a therapeutic purpose.
No
The device is an implant for cervical fusion procedures, used to treat disc degeneration, not to diagnose a condition.
No
The device description clearly states it is comprised of PEEK cages and titanium screws, which are physical hardware components, not software.
Based on the provided information, 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 and Intended Use: The description clearly states that this device is an implantable surgical device (a fusion cage with screws) used in the cervical spine to facilitate bone fusion. It is physically placed within the patient's body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is structural support and promoting bone growth in vivo.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.
Product codes
ODP, OVE
Device Description
The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. 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. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
cervical disc, C2-C3 disc to the C7-T1 disc
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the subject device consisted of static compression, static compression shear, static torsion, static load induced subsidence, static expulsion, dynamic compression, dynamic compression shear and dynamic torsion. All testing was conducted per ASTM F-2077 and ASTM F-2267 guidelines and the device performed as designed and met or exceeded all product specifications. In addition, wear testing was performed in order to determine the characteristics of any particulate wear debris generated during the tests. The result from the wear testing was found to be substantially equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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510(k) Summary (21 CFR Part 807.92)
Submitter Information A.
Submitter's Name: Theken Spine, LLC DEC 16 2010 Address: 1800 Triplett Blvd. Akron, Ohio 44306 Telephone Number: 330-475-8600 Fax Number: 330-773-7697 Contact Person: Dale Davison Date Prepared: 08/16/2010 B. Device Information Trade Name: Cervical Standalone Intervertebral Body Fusion Device Common Name: Cervical Standalone Intervertebral Body Fusion Device Classification Name: Spinal Intervertebral Body Fusion Device (per 21 CFR 888.3080) Device Classification: Class 11 (per 21 CFR 888.3080) Panel: Orthopedic, Product Code: ODP Medtronic Sofamor Danek, PEEK PREVAIL™ Cervical Interbody Predicate Device: Device (K073285) Globus Medical Inc. COALITIONTM Spacer Intervertebral Body Fusion Device (K083389) Material Composition: Polyetherctherketone (PEEK-OPTIMA LT) per ASTM F-2026 Tantalum per ASTM F-560, and Titanium 6AI-4V ELI per ASTM F-136 Subject Device Description: The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. 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. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation. Intended Use: The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.
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The technological characteristics of the Cervical Technological Characteristics: Standalone Intervertebral Body Fusion Device are equivalent to the predicate device COALITION Spacer Intervertebral Body Fusion Device (K083389) manufactured by Globus Medical Inc. These technological characteristics include the same indications for use, design concepts, feature comparisons, and known biocompatible materials. Summary of test data: Mechanical testing of the subject device consisted of static compression, static compression shear, static torsion, static load
induced subsidence, static expulsion, dynamic compression, dynamic compression shear and dynamic torsion. All testing was conducted per ASTM F-2077 and ASTM F-2267 guidelines and the device performed as designed and met or exceeded all product specifications. In addition, wear testing was performed in order to determine the characteristics of any particulate wear debris generated during the tests. The result from the wear testing was found to be substantially equivalent to legally marketed devices.
C. Substantial Equivalence
Theken Spine believes that sufficient evidence exists to reasonably conclude that the Cervical Standalone Intervertebral Body Fusion Device is substantially equivalent to the predicate device COALITION™ Spacer Intervertebral Body Fusion Device (K083389) manufactured by Globus Medical Inc. 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 analysis. All implants o represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.
Substantial equivalence include:
- The same Indications for use ●
- The same basic design ●
- The same operating principle ●
- . The same materials
- The same manufacturing environment
- The same sterilization process .
- The same packaging configurations .
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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 & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
Re: K102323
Trade/Device Name: Cervical Standalone Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: November 12, 2010 Received: November 15, 2010
SEP 1 2 201
Dear Mr. Davison:
This letter corrects our substantially equivalent letter of December 16, 2010.
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
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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Wilkerson
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):
DEC 1 6 2010
Device Name: Cervical Standalone Intervertebral Body Fusion Device
Indications For Use: .
The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.
Prescription Use Over-The-Counter Use AND/OR (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)
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(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102323