(120 days)
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Not Found
No
The provided text describes a physical intervertebral body fusion device made of PEEK-OPTIMA®. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The device relies on mechanical properties and radiographic markers for positioning, not intelligent analysis.
Yes
The device is used to facilitate fusion in patients with Degenerative Disc Disease, which is a therapeutic intervention.
No
The device is an intervertebral body device used for fusion in patients with degenerative disc disease, not for diagnosing conditions. Its purpose is treatment, not diagnosis.
No
The device description explicitly states the device is made of PEEK-OPTIMA® and describes physical configurations and features (ridged teeth, tantalum markers), indicating it is a physical implant, not software.
Based on the provided text, the Talos™ IBF Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Talos™ IBF Device is an implantable medical device designed to be surgically placed in the lumbar spine. It does not analyze or test biological samples.
- The intended use is for surgical implantation to facilitate spinal fusion. This is a therapeutic intervention, not a diagnostic test.
- The device description details the physical characteristics of an implant. It describes the material, configurations, sizes, and features for surgical placement and radiological confirmation.
The mention of "radiographic studies" in the intended use refers to the diagnostic imaging used to confirm the patient's condition (Degenerative Disc Disease) before the device is implanted, not a function of the device itself.
N/A
Intended Use / Indications for Use
The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos™ IBF devices are intended to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment.
Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, and the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
Product codes
MAX
Device Description
The Talos™ IBF Device is made of PEEK-OPTIMA®. Talos™ IBF Device is available in four The configurations: Talos™-P, Talos™-T, Talos™-L, and Talos™-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos™-P and Talos™-L are rectangular devices and the Talos™-T and Talos™-A 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 allow the Talos™ IBF radiological confirmation for proper positioning.
The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and Talos™ IBF devices are intended radiographic studies. to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment. Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, while the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, lumbosacral spine (L2-S1)
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was conducted per ASTM F 2077-03 and ASTM F 2267-04.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
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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PREMARKET NOTIFICATION 510(K) SUMMARY
Company:
Telephone
| Company Name | Meditech Advisors, LLC |
|---|---|
| Street address | 878 Briarcliff Rd, Unit A-2 |
| City, State, Zip | Atlanta, GA 30306 |
| Code |
404-879-0993
JUL 1 5 2009
Company Contact: Eric Flickinger
Common Name Interbody fusion device
Trade Name: Talos™ Intervertebral Body Fusion (IBF) Device
Classification/Code: Class II, MAX, 888.3080
Device Description: The Talos™ IBF Device is made of PEEK-OPTIMA®. Talos™ IBF Device is available in four The configurations: Talos™-P, Talos™-T, Talos™-L, and Talos™-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos™-P and Talos™-L are rectangular devices and the Talos™-T and Talos™-A 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 allow the Talos™ IBF radiological confirmation for proper positioning.
The Talos™ IBF Device is an intervertebral body device Intended Use: intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and Talos™ IBF devices are intended radiographic studies. to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment. Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, while the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
Performance Data: Talos™ IBF devices conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices, June 12, 2007. Mechanical testing was conducted per ASTM F 2077-03 and ASTM F 2267-04.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2009
Meditech Advisors, LLC c/o Ms. Janet Webb President 950 N. Michigan Ave., Suite 2202 Chicago, Illinois 60611
Re: K090707
Trade/Device Name: Talos Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 29, 2009 Received: June 2, 2009
Dear Ms. Webb:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA); it may be subject to such 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); 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.
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Page 2 - Ms. Janet Webb
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Buchen
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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Talos™ IBF 510(k) Application
Indication for Use Statement
510(k) Number : KO90707
Device Name: Talos™ Intervertebral Body Fusion Device
Indications for Use:
The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos™ IBF devices are intended to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment.
Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, and the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
Prescription Use × (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K 890702 510(k) Number_