ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology

K190959 · Medtronic Sofamor Danek USA, Inc. · MAX · Jul 3, 2019 · Orthopedic

Device Facts

• Record ID: K190959
• Device Name: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Additive manufactured titanium intervertebral body fusion cages; various widths, lengths, heights, and lordotic angles. Implanted between lumbar/lumbosacral vertebral bodies to provide support and correction during fusion surgery. Articulating assembly allows placement while attached to inserter. Open geometry packed with autograft, allograft (cancellous/corticocancellous), or demineralized allograft with bone marrow aspirate. Used in OR by surgeons; requires supplemental internal fixation. Benefits include spinal stabilization and facilitation of bone fusion.

Clinical Evidence

No new clinical trials conducted. Evidence provided via published clinical outcomes supporting the use of demineralized allograft bone with bone marrow aspirate in spinal fusion procedures.

Technological Characteristics

Additive manufactured titanium cages. MRI safety evaluated per ASTM F2052, F2213, F2119, and F2182. Not compatible with stainless steel implants. Non-standalone; requires supplemental internal fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain, confirmed by history/radiography) at 1-2 contiguous lumbar levels (L2-S1) or spinal deformities as an adjunct to fusion. Requires 6 months of failed non-operative treatment. Contraindicated for stand-alone use; must be used with supplemental internal fixation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ARTiC-L™ 3D and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology (K171689)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] |
| | Fax: [phone] |
| 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<br>for use with supplemental internal fixation systems. |
| | The ARTiC-XL™ 3D Ti Spinal System with TiONICT™ Technology is indicated for use<br>as an intervertebral body fusion device in skeletally mature patients with degenerative disc<br>disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed<br>by patient history and radiographic studies) at one or two contiguous levels of the lumbar<br>spine (L2-S1). Additionally, the ARTiC-XL™ 3D Ti Spinal System with TiONIC TM<br>technology can be used in patients diagnosed with spinal deformities as an adjunct to<br>fusion. These patients should be skeletally mature and have undergone 6 months of non-<br>operative treatment prior to surgery. These implants are used to facilitate fusion in the<br>lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous<br>and/or corticocancellous bone graft, and/or demineralized allograft bone with bone<br>marrow aspirate. |
| Comparison of<br>Technological<br>Characteristics with<br>the Predicate Devices | ARTiC-L™ 3D Ti and ARTiC-XL™ 3D Ti Spinal System devices have the same<br>fundamental scientific technology; indications for use, intended use, design, material<br>levels of attachment as the predicate devices. The predicate and subject devices are<br>intended for stabilization use and to promote bone fusion during the normal healing<br>process following surgical correction of disorders of the spine. Both the ARTiC-L™ 3D<br>Ti and ARTiC-XL™ 3D Ti Spinal System devices were originally cleared for use with<br>autogenous bone and/or allogenic bone graft comprised of cancellous and/or cortico-<br>cancellous bone graft. The subject application provides published clinical outcomes to<br>support the use of demineralized allograft bone with bone marrow aspirate. |
| Performance Data | MRI Safety Evaluation<br>MRI Safety Evaluation was previously completed in accordance with:<br>ASTM F2052:2015: Standard test method for measurement of magnetically induced<br>displacement force on passive implants in the magnetic resonance environment ASTM F2213:2006 (R11): Standard test method for measurement of magnetically<br>induced torque on medical devices in the magnetic resonance environment ASTM F2119:2007(R13): Standard test method for evaluation of MR image artifacts<br>from passive implants ASTM F2182:2002a, 2011, 2011a: Standard test method for measurement of radio<br>frequency induced heating on or near passive implant during magnetic resonance<br>imaging |
| | Design Validation<br>A minor change was included in the surgical technique, but this only involves the<br>inclusion of demineralized allograft bone mixed with bone marrow aspirate and does not<br>impact implant or instrument design. |
| | Clinical Outcomes<br>Clinical outcomes on the usage of demineralized allograft bone combined with bone<br>marrow aspirate were provided to support this application. |
| Conclusion | Based upon the supporting documentation provided in the pre-market notification, the<br>subject ARTiC-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti Spinal System are safe<br>and effective as the predicate ARTiC-L™ 3D Ti Spinal System and the ARTiC-XL™ 3D<br>Ti Spinal System found in K171689, when demineralized allograft bone combined with<br>bone marrow aspirate is used. |

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