(184 days)
K 122850
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for use in treating Degenerative Disc Disease of the cervical spine by facilitating fusion, which is a therapeutic purpose.
No.
The device is an intervertebral body fusion device used for treatment, not diagnosis. While its use is for a condition confirmed by "radiographic studies," the device itself does not perform diagnostics.
No
The device description clearly states the device is made of HA PEEK and includes physical components like ridged teeth and tantalum markers. It is an implantable hardware device.
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 about a person's health.
- Device Description and Intended Use: The Talos®-C (HA) Cervical Intervertebral Body Fusion Device is an implantable medical device designed to be surgically placed in the cervical spine to facilitate fusion in patients with degenerative disc disease. It is a physical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic testing performed on samples outside the body.
Therefore, the Talos®-C (HA) Cervical Intervertebral Body Fusion Device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.
Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one level from C2-T1
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)
Tests according to ASTM 2077 and ASTM 2267 were performed on the Talos®-C (HA) Cervical IBF Devices to establish equivalency to the predicate device. The tests include static compression, compression shear and torsion tests, dynamic compression, compression shear and torsion tests, as well as subsidence testing. Simulated aging was performed on Talos®-C (HA) IBF Devices, which then were subjected to additional dynamic compression and torsion tests in accordance with ASTM 2077. The Talos®-C (HA) is equal in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
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.
K 122850
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2015
Meditech Spine, LLC Mr. Jason Gromek Director of Engineering 1447 Peachtree Street, Northeast, Suite 440 Atlanta, Georgia 30309
Re: K142345
Trade/Device Name: Talos -C (HA) Cervical Intervertebral Body Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 20, 2015 Received: January 22, 2015
Dear Mr. Gromek:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
meditech spir
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
Indications for Use Form
510(k) Number (if known): K142345
Device Name: Talos®-C (HA) Cervical Intervertebral Body Fusion Devices
Indications for Use:
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.
Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
meditech spine, IIc
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
510(k) Summary
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Talos®-C (HA) Cervical Intervertebral Body Fusion Devices. Summary prepared on the 18th of February, 2015.
| A. Sponsor/Manufacturer: | Meditech Spine, LLC | |
|---|---|---|
| Registration Number: | 3009405289 | |
| Jason Gromek, Director of Engineering | ||
| 1447 Peachtree St NE Suite 440 | ||
| Atlanta, GA 30309 | ||
| 678-974-5287 Phone | ||
| 404-759-2104 Fax |
- B. Trade Name: Talos®-C (HA) Cervical Intervertebral Body Fusion Devices Common Name: Spinal Implant Classification Name: Intervertebral body fusion device (21 CFR 888.3080 Class II, Product Code ODP)
- Predicate Device: K 122850: Meditech Advisors, LLC Talos®-C Cervical ﻥ Intervertebral Body Fusion Devices
D. Device Description:
The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.
ت Intended Use:
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.
Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.
4
meditech spine, IIc
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos® -C (HA) Cervical IBF Devices are also to be used with supplemental fixation.
-
F. Technological Characteristics:
The technological characteristics of the Talos®C (HA) Cervical IBF Devices are the same as the predicate device, except for the material. The new material is hydroxyapatite filled polyetheretherketone (HA PEEK). HA is a naturally occurring mineral in bone and is widely used in the orthopedic field. -
G. Non-clinical Testing:
Tests according to ASTM 2077 and ASTM 2267 were performed on the Talos®-C (HA) Cervical IBF Devices to establish equivalency to the predicate device. The tests include static compression, compression shear and torsion tests, dynamic compression, compression shear and torsion tests, as well as subsidence testing. Simulated aging was performed on Talos®-C (HA) IBF Devices, which then were subjected to additional dynamic compression and torsion tests in accordance with ASTM 2077. The Talos®-C (HA) is equal in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness. -
H. Conclusion:
The testing completed as well as a comparison of the technological characteristics have demonstrated that the Talos®-C (HA) Cervical IBF Devices are substantially equivalent to the predicate device.