(114 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of HA PEEK, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical testing and endotoxin levels, not algorithmic performance.
Yes
The device is intended to treat Degenerative Disc Disease, which is a medical condition, making it a therapeutic device.
No
The device is an intervertebral body fusion device used for treatment of degenerative disc disease, not for diagnosis. While its use is tied to diagnosis of DDD, it is a treatment device.
No
The device description clearly states it is made of a polymer (HA PEEK) and is an implantable intervertebral body device, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Talos® Lumbar (HA) PEEK IBF device is an implantable medical device designed to be surgically placed in the lumbar spine to treat degenerative disc disease. It is a physical device used in vivo (within the body) for structural support and fusion.
- Lack of Diagnostic Testing: The description focuses on the device's material, design, intended use for surgical implantation, and mechanical testing. There is no mention of it performing any tests on biological samples or providing diagnostic information.
- Input: The input mentioned is "Radiographic studies," which are imaging techniques used to assess the spine, not biological samples for diagnostic testing.
Therefore, the Talos® Lumbar (HA) PEEK IBF device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Talos® Lumbar (HA) PEEK 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® Lumbar (HA) PEEK IBF devices are intended to be used with autograft and/ or allograft comprised of cancellous and/or corticocancellous bone graft.
The Talos® Lumbar (HA) PEEK IBF Device is to be used in patients who have had six months of non- operative treatment.
Talos® Lumbar (HA) PEEK IBF devices are to be implanted via a direct posterior, transforaminal, laterior or anteriolateral approach in the lumbosacral spine. The Talos®-P WB (HA), Talos®-TL (HA), Talos®-T (HA), Talos®-L (HA), and Talos®-A (HA) are intended to be used with supplemental fixation.
Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.
Product codes
MAX
Device Description
The Talos® Lumbar (HA) PEEK IBF Devices are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The Talos® Lumbar (HA) PEEK IBF Device is available in six configurations: Talos®-P (HA), Talos®-P WB (HA), Talos®-T (HA), Talos®-TL (HA), Talos®-L (HA), and Talos®-A (HA). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-P (HA), Talos®-P WB (HA), Talos® –TL (HA) and Talos® –L are rectangular devices. The Talos® –T (HA) and Talos® – A (HA) 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 anatomy. In addition, tantalum or titanium markers at the opposite ends are offered which allow radiological confirmation for proper IBF positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2-S1, lumbosacral spine
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)
Non-clinical Testing: Testing per ASTM F2077 (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear) and ASTM F2267 (Subsidence) was performed on the Talos® Lumbar (HA) PEEK IBF devices to establish equivalency to the predicate device. Confirmation was achieved that the Talos® Lumbar (HA) PEEK IBF devices are substantially equivalent in safety and efficacy to the predicate device. In addition, bacterial endotoxin testing (BET) has been performed. BET as specified in ANSI/AAMI ST-72:2011 confirm an endotoxin limit less than 20EU per 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.
0
Public Health Service
Image /page/0/Picture/2 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 three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected, and they form a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
June 2, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Meditech Spine, LLC Bruce Dunaway Chief Design Engineer 1447 Peachtree Street NE Suite 440 Atlanta, Georgia 30309
Re: K170395
Trade/Device Name: Talos® Lumbar (HA) PEEK IBF Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 4, 2017 Received: March 8, 2017
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. 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 of medical device
1
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 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/ResourcesforYou/Industry/default.htm. 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
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/Resourcesfor You/Industry/default.htm.
Sincerely,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170395
Device Name Talos® Lumbar (HA) PEEK IBF Devices
Indications for Use (Describe)
The Talos® Lumbar (HA) PEEK 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® Lumbar (HA) PEEK IBF devices are intended to be used with autograft and/ or allograft comprised of cancellous and/or corticocancellous bone graft.
The Talos® Lumbar (HA) PEEK IBF Device is to be used in patients who have had six months of non- operative treatment.
Talos® Lumbar (HA) PEEK IBF devices are to be implanted via a direct posterior, transforaminal, laterior or anteriolateral approach in the lumbosacral spine. The Talos®-P WB (HA), Talos®-TL (HA), Talos®-T (HA), Talos®-L (HA), and Talos®-A (HA) are intended to be used with supplemental fixation.
Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ----------------------------------------------- |
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3
meditech spi
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
510(k) Summarv
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Talos® Lumbar (HA) PEEK IBF.
| 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 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Trade Name: | Talos® Lumbar (HA) PEEK IBF Devices |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral body fusion device (21 CFR 888.3080 Class II,
Product Code MAX) |
| C. Predicate Devices: | K 150788: Meditech Spine, LLC Talos® Intervertebral Body Fusion
Devices (Primary)
K090707: Meditech Advisors, LLC Talos® Intervertebral Body
Fusion Devices (Additional) |
D. Device Description:
The Talos® Lumbar (HA) PEEK IBF Devices are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The Talos® Lumbar (HA) PEEK IBF Device is available in six configurations: Talos®-P (HA), Talos®-P WB (HA), Talos®-T (HA), Talos®-TL (HA), Talos®-L (HA), and Talos®-A (HA). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-P (HA), Talos®-P WB (HA), Talos® –TL (HA) and Talos® –L are rectangular devices. The Talos® –T (HA) and Talos® – A (HA) 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 anatomy. In addition, tantalum or titanium markers at the opposite ends are offered which allow radiological confirmation for proper IBF positioning.
- E. Intended Use:
Talos® Lumbar (HA) PEEK IBF Devices are intervertebral body devices 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.
4
meditech spine, IIc
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos® Lumbar (HA) PEEK IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The Talos® Lumbar (HA) IBF PEEK Device is to be used in patients who have had six months of non- operative treatment.
Talos® Lumbar (HA) PEEK IBF Devices are to be implanted via a direct posterior, transforaminal, lateral, or anterior approach in the lumbosacral spine. The Talos®-A (HA), Talos®-L (HA), Talos®-P (HA), Talos®-P WB (HA), Talos®-T (HA) and Talos®-TL (HA) are intended to be used with supplemental fixation.
Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.
-
F. Technological Characteristics:
The technological characteristics of the Talos® Lumbar (HA) PEEK IBF devices are identical to the predicate devices in terms of indications for use and intended use. Size offerings and choices of lordotic angles have been expanded for the Talos® Lumbar (HA) PEEK IBF Devices. The significant difference between the Talos® Lumbar (HA) PEEK IBF Devices and the predicate is in material composition: hydroxyapatite impregnated polyetheretherketone (HA PEEK) vs. polyetheretherketone (PEEK) -
G. Non-clinical Testing:
Testing per ASTM F2077 (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear) and ASTM F2267 (Subsidence) was performed on the Talos® Lumbar (HA) PEEK IBF devices to establish equivalency to the predicate device. Confirmation was achieved that the Talos® Lumbar (HA) PEEK IBF devices are substantially equivalent in safety and efficacy to the predicate device. In addition, bacterial endotoxin testing (BET) has been performed. BET as specified in ANSI/AAMI ST-72:2011 confirm an endotoxin limit less than 20EU per device. -
H. Conclusion:
The Talos® Lumbar (HA) PEEK IBF devices have identical indications for use, intended use, technological characteristics, design, and principles of operation as their predicate devices; as well as similar size and geometric offerings. The differentiating characteristic is the device material, which has been proven to perform equivalently to the predicate device material. The Talos® Lumbar (HA) PEEK IBF devices are substantially equivalent in safety and efficacy to the predicate device.