(82 days)
Not Found
No
The summary describes a physical spinal implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a spinal system indicated for use as an intervertebral body fusion device to treat degenerative disc disease and spinal deformities, which directly addresses a medical condition to restore function.
No
The device is an intervertebral body fusion device and is used to facilitate fusion in the lumbar spine, not to diagnose a condition.
No
The device description clearly states it consists of "additive manufactured titanium cages" and is an "intervertebral body fusion device," indicating it is a physical implant, not software.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the ARTiC-L™ and ARTiC-XL™ 3D Ti Spinal Systems are implants used in surgical procedures to facilitate fusion in the lumbar spine. They are physical devices inserted into the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its purpose is structural support and fusion.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-LIM 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/ or demineralized allograft bone marrow aspirate. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-XLIM 3D Ti Spinal System with TiONIC TM technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/ or demineralized allograft bone with bone marrow aspirate.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The ARTiC-L™ 3D Ti Spinal System with TiONICTM technology consists of additive manufactured titanium cages of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The articulating device assembly allows for placement of implant while remaining attached to inserter. The open geometry of the implants allows them to be packed with autograft bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone (e.g., minimally manipulated allograft such as Grafton™ DBM DBF, etc.) Demineralized bone must be used with bone marrow aspirate. The device is not intended to be used as a stand-alone implant. Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar 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
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)
MRI Safety Evaluation was previously completed in accordance with: ASTM F2052:2015: Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment ASTM F2213:2006 (R11): Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment ASTM F2119:2007(R13): Standard test method for evaluation of MR image artifacts from passive implants ASTM F2182:2002a, 2011, 2011a: Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging.
Design Validation: A minor change was included in the surgical technique, but this only involves the inclusion of demineralized allograft bone mixed with bone marrow aspirate and does not impact implant or instrument design.
Clinical Outcomes: Clinical outcomes on the usage of demineralized allograft bone combined with bone marrow aspirate were provided to support this application.
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
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2019
Medtronic Sofamor Danek USA, Inc Emmarie Halteman Associate Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K190959
Trade/Device Name: ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology, ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 11, 2019 Received: June 13, 2019
Dear Emmarie Halteman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190959
Device Name
ARTiC-L™ 3D Ti Spinal System with TiONIC ™ Technology and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology
Indications for Use (Describe)
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-LIM 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/ or demineralized allograft bone marrow aspirate. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-XLIM 3D Ti Spinal System with TiONIC TM technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/ or demineralized allograft bone with bone marrow aspirate.
| 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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510(k) Summary Medtronic Sofamor Danek ARTiC-L™ 3D Ti and ARTiC-XL™ 3D Ti Spinal System with TiONIC ™ Technology
| April 2019 | |
|---|---|
| Submitter | Medtronic Sofamor Danek USA |
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901) 396-3133 | |
| Fax: (901) 346-9738 | |
| Contact(s) | Emmarie Halteman |
| Associate Regulatory Affairs Specialist | |
| Direct Telephone – 901-399-2216 | |
| Date Prepared | April 10th, 2019 |
| Common Name | ARTiC-L™ 3D Ti Spinal System with TiONICTM Technology |
| ARTiC-XL™ 3D Ti Spinal System with TiONICTM Technology | |
| Regulatory Class | Class II |
| Regulation Number | 888.3030 |
| Regulation Name | Intervertebral Body Fusion Device with Bone Graft |
| Device Product | MAX |
| Classification Code | MAX |
| Predicate Devices | K171689 ARTiC-L™ 3D and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ |
| Technology (SE 10/05/17) | |
| These predicate devices have not been subject to a design related recall | |
| Description of Device | The ARTiC-L™ 3D Ti Spinal System with TiONICTM technology consists of additive |
| manufactured titanium cages of various widths, lengths, heights, and lordotic angles to | |
| accommodate patient anatomy. These devices can be inserted between two lumbar or | |
| lumbosacral vertebral bodies to give support and correction during lumbar interbody | |
| fusion surgeries. The articulating device assembly allows for placement of implant while | |
| remaining attached to inserter. The open geometry of the implants allows them to be | |
| packed with autograft bone graft and/or allogenic bone graft comprised of cancellous | |
| and/or corticocancellous bone, and/or demineralized allograft bone (e.g., minimally | |
| manipulated allograft such as Grafton™ DBM DBF, etc.) Demineralized bone must be | |
| used with bone marrow aspirate. The device is not intended to be used as a stand-alone | |
| implant. | |
| Stainless steel and titanium implants are not compatible. They must not be used together | |
| in a construct. As with all orthopedic implants, in no case may the implants be re-used. | |
| No warranties, express or implied, are made. Implied warranties of merchantability and | |
| fitness for a particular purpose or use are specifically excluded. | |
| Indications for Use: | The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as |
| an intervertebral body fusion device in skeletally mature patients with degenerative disc | |
| disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed | |
| by patient history and radiographic studies) at one or two contiguous levels of the lumbar | |
| spine (L2-S1). Additionally, the ARTiC-L™ 3D Ti Spinal System with TiONIC™ | |
| technology can be used in patients diagnosed with spinal deformities as an adjunct to | |
| fusion. These patients should be skeletally mature and have undergone 6 months of non- | |
| operative treatment prior to surgery. These implants are used to facilitate fusion in the | |
| lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous | |
| and/or corticocancellous bone graft, and/or demineralized allograft bone with bone | |
| marrow aspirate. When used as an interbody fusion device, these implants are intended | |
| for use with supplemental internal fixation systems. | |
| The ARTiC-XL™ 3D Ti Spinal System with TiONICT™ Technology is indicated for use | |
| as an intervertebral body fusion device in skeletally mature patients with degenerative disc | |
| disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed | |
| by patient history and radiographic studies) at one or two contiguous levels of the lumbar | |
| spine (L2-S1). Additionally, the ARTiC-XL™ 3D Ti Spinal System with TiONIC TM | |
| technology can be used in patients diagnosed with spinal deformities as an adjunct to | |
| fusion. These patients should be skeletally mature and have undergone 6 months of non- | |
| operative treatment prior to surgery. These implants are used to facilitate fusion in the | |
| lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous | |
| and/or corticocancellous bone graft, and/or demineralized allograft bone with bone | |
| marrow aspirate. | |
| Comparison of | |
| Technological | |
| Characteristics with | |
| the Predicate Devices | ARTiC-L™ 3D Ti and ARTiC-XL™ 3D Ti Spinal System devices have the same |
| fundamental scientific technology; indications for use, intended use, design, material | |
| levels of attachment as the predicate devices. The predicate and subject devices are | |
| intended for stabilization use and to promote bone fusion during the normal healing | |
| process following surgical correction of disorders of the spine. Both the ARTiC-L™ 3D | |
| Ti and ARTiC-XL™ 3D Ti Spinal System devices were originally cleared for use with | |
| autogenous bone and/or allogenic bone graft comprised of cancellous and/or cortico- | |
| cancellous bone graft. The subject application provides published clinical outcomes to | |
| support the use of demineralized allograft bone with bone marrow aspirate. | |
| Performance Data | MRI Safety Evaluation |
| MRI Safety Evaluation was previously completed in accordance with: | |
| ASTM F2052:2015: Standard test method for measurement of magnetically induced | |
| displacement force on passive implants in the magnetic resonance environment ASTM F2213:2006 (R11): Standard test method for measurement of magnetically | |
| induced torque on medical devices in the magnetic resonance environment ASTM F2119:2007(R13): Standard test method for evaluation of MR image artifacts | |
| from passive implants ASTM F2182:2002a, 2011, 2011a: Standard test method for measurement of radio | |
| frequency induced heating on or near passive implant during magnetic resonance | |
| imaging | |
| Design Validation | |
| A minor change was included in the surgical technique, but this only involves the | |
| inclusion of demineralized allograft bone mixed with bone marrow aspirate and does not | |
| impact implant or instrument design. | |
| Clinical Outcomes | |
| Clinical outcomes on the usage of demineralized allograft bone combined with bone | |
| marrow aspirate were provided to support this application. | |
| Conclusion | Based upon the supporting documentation provided in the pre-market notification, the |
| subject ARTiC-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti Spinal System are safe | |
| and effective as the predicate ARTiC-L™ 3D Ti Spinal System and the ARTiC-XL™ 3D | |
| Ti Spinal System found in K171689, when demineralized allograft bone combined with | |
| bone marrow aspirate is used. |
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