(98 days)
Not Found
No
The summary describes a physical implant device made of PEEK or HA PEEK, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "Intervertebral Body Fusion Device" used for "anterior cervical interbody fusion" in patients with specific spinal conditions. Its intended use is to facilitate fusion and provide stability in the spine, which directly fits the definition of a therapeutic device designed to treat a medical condition.
No
This device is a fusion device (intervertebral body fusion device) designed to facilitate the fusion of vertebrae in the spine, not to diagnose medical conditions. It is used after diagnosis by imaging studies.
No
The device description clearly states that the device is made of physical materials (PEEK and HA PEEK) and is an implantable intervertebral body fusion device, which is a hardware component.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Talos®-C Cervical Intervertebral Body Fusion Devices are implants made of PEEK or HA PEEK, designed to be surgically inserted into the spine to facilitate fusion. Their intended use is for treating cervical disc degeneration and instability by providing structural support and space for bone graft.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient. The device is a physical implant.
Therefore, the Talos®-C Cervical Intervertebral Body Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Device or anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion and with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and or craft to faciliate fusion. Non-operative treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach.
Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
Talos®-C(HA) Cervical Intervertebral Body Fusion Devices
The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fuss are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. Non-operative tratment pror to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) Veeks. Talos®-C(HA) Cervices are to be implemented via an open anterior approach approach.
Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperloriotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® C 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, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.
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, titanium 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
radiographs, CT, MRI
Anatomical Site
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)
Testing according to ASTM F2077-11 and ASTM 2267-04 was performed on the previously cleared Talos®-C and Talos®-C (HA) Cervical IBF Devices. The tests included static compression, compression shear and torsion tests, dynamic compression shear and torsion tests, as well as subsidence testing bending. Finite Element Analysis and engineering analysis were performed on the subject devices to confirm that a new worst-case is not presented in the proposed devices. Talos®-C and Talos®-C (HA) Cervical IBF Devices are superior in mechanical function and properties to the cleared device.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2020
Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, Georgia 30309
Re: K201506
Trade/Device Name: Talos -C Cervical Intervertebral Body Fusion System, Talos -C (HA) Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 12, 2020 Received: August 13, 2020
Dear Mr. Dunaway:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K201506
Device Name
Talos®-C Cervical Intervertebral Body Fusion System Talos®-C (HA) Cervical Intervertebral Body Fusion System
Indications for Use (Describe) Talos®-C Cervical Intervertebral Body Fusion Devices
The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Device or anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos@-C Cervical Intervertebral Body Fusion and with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and or craft to faciliate fusion. Non-operative treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach.
Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
Talos®-C(HA) Cervical Intervertebral Body Fusion Devices
The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fuss are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. Non-operative tratment pror to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) Veeks. Talos®-C(HA) Cervices are to be implemented via an open anterior approach approach.
Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperloriotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a stylized letter 'M' logo. The 'M' is formed by two rounded rectangles, one in a darker shade of blue and the other in a lighter shade of blue, intersecting each other. To the bottom right of the 'M' is a solid blue circle, completing the logo.
510(k) Summary
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Talos®-C and Talos®-C(HA) Cervical Intervertebral Body System
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A. Sponsor/Manufacturer: Meditech Spine, LLC
Registration Number: 3009405289 Bruce Dunaway, Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, GA 30309 678-974-5287 Phone 404-759-2104 Fax -
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-B. Trade Name: C (HA) Cervical Intervertebral Body Fusion System Common Name: Spinal Implant Intervertebral Body Fusion Device (21 CFR 888.3080 Class II,Product Classification Code ODP) Name:
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C. Predicate Device: K150788 (Talos®-C and Talos®-C (HA) Devices) (Primary) K173347 Actilif C FLX (Additional) K163491 CoRoent Small (Additional)
D. Purpose of Submission:
The Purpose of this submission is to expand product offering of the Talos®-C Cervical Intervertebral Body Devices and the Talos®C (HA) Cervical Intervertebral Body Devices to include two additional lordotic angles on all footprints greater than 12mm x 12mm (including the introduction of an 18mm x 15mm footprint). Additionally, the revision of the Indication for Use to expand usage from "one level" to "multiple contiguous levels".
- E. Device Description:
The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The
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Image /page/4/Picture/1 description: The image shows a logo with a stylized letter 'M'. The 'M' is formed by two rounded shapes, one vertical and one angled, overlapping each other. The vertical shape is a lighter shade of blue, while the angled shape is a darker shade of blue. To the right of the 'M' is a solid dark blue circle, positioned slightly below the center of the 'M'.
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, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.
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, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.
- F. Indication for Use:
Talos®-C Cervical Intervertebral Body Fusion Devices
The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos® -C Cervical Intervertebral Body Fusion Devices are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach.
Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic devices (lordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices
The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices
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Image /page/5/Picture/1 description: The image shows a logo with a stylized letter "M". The "M" is formed by two overlapping shapes, one in a lighter shade of blue and the other in a darker shade of blue. To the right of the "M" is a solid dark blue circle. The logo has a modern and minimalist design.
are intended to be used with supplemental fixation. The Talos-C® (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. Nonoperative 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 implemented via an open anterior approach.
Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic devices (lordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
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G. Technological Characteristics:
The following fundamental technological characteristics of the Talos®-C (HA) Cervical IBF Devices are identical to the cleared device: -
-Intended Use: See IFU
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-Material: PEEK / HA PEEK
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-Implant Markers: Tantalum / Titanium
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-Design: Rectangular, teeth on inferior and superior surfaces, insertion feature
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-Sterilization / Packaging: Gamma
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-Instrumentation: See Surgical Technique
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H. Non-clinical Testing:
Testing according to ASTM F2077-11 and ASTM 2267-04 was performed on the previously cleared Talos®-C and Talos®-C (HA) Cervical IBF Devices. The tests included static compression, compression shear and torsion tests, dynamic compression shear and torsion tests, as well as subsidence testing bending. Finite Element Analysis and engineering analysis were performed on the subject devices to confirm that a new worst-case is not presented in the proposed devices. Talos®-C and Talos®-C (HA) Cervical IBF Devices are superior in mechanical function and properties to the cleared device.
- I. Conclusion:
The identical intended use and consistency between the fundamental scientific technology between the Talos®-C and Talos®-C (HA) Cervical IBF Devices allows that both are substantially equivalent to the cleared device.