Endoskeleton TCS Interbody Fusion Device

K191565 · Titan Spine, Inc. · OVE · Aug 6, 2019 · Orthopedic

Device Facts

• Record ID: K191565
• Device Name: Endoskeleton TCS Interbody Fusion Device
• Applicant: Titan Spine, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Aug 6, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

Device Story

Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion system; implants feature hollow centers for bone graft material; superior/inferior surfaces utilize nanoLOCK™ (MMN™) acid-etched surface treatment for bone fixation. System includes optional titanium alloy locking plate to prevent integrated screw back-out. Device used in cervical spine surgery by surgeons; placed across disc space. Construct functions as stand-alone system when used with integrated screws; requires supplemental fixation if screws are not used. Plate design includes holding feature for inserter tool. Benefits include stabilization of disc space to facilitate fusion in DDD patients.

Clinical Evidence

Bench testing only. Testing included locking plate resistance to screw push-out and retention force of the plate holder.

Technological Characteristics

Materials: Medical grade titanium alloy (Ti-6Al-4V-EL). Surface treatment: nanoLOCK™ (MMN™) acid-etched (on IBD only). Form factor: Interbody spacer with optional locking plate. Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one disc level from C2 to T1, following 6 weeks of failed non-operative treatment. Used with autograft or allograft cancellous bone.

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

• Titan Spine Endoskeleton® TCS Interbody Fusion Device (K142940, K153122, K173535, K183557)
• Life Spine Pro-Link Ti Stand Alone Cervical Spacer System (K180642)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.

August 6, 2019

Titan Spine, Inc. % Christine Scifert Exec VP MRC/X, LLC 6075 Poplar Ave Memphis, Tennessee 38119

Re: K191565

Trade/Device Name: Endoskeleton® TCS Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 17, 2019 Received: July 19, 2019

Dear Christine Scifert:

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191565

#### Device Name

Endoskeleton® TCS Interbody Fusion Device

#### Indications for Use (Describe)

The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------|
| <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
| <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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#### 510(k) Summary

Endoskeleton® TCS Interbody Fusion Device July 17, 2019

| Company: | Titan Spine, Inc.<br>6140 West Executive Drive, Suite A Mequon,<br>WI 53092, USA |
|--------------------------------|-------------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | 3006340236 |
| Primary Contact: | Christine Scifert<br>Phone: [phone] |
| Company Contact: | Kelly McDonnell<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Endoskeleton® TCS Interbody Fusion Device |
| Common Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | 87- Orthopedic |
| Product Code: | OVE |
| Predicate Devices: | Primary Predicate: |
| | Titan Spine Endoskeleton® TCS Interbody Fusion Device - K142940, K153122,<br>K173535, & K183557 |
| | Secondary Predicate:<br>Life Spine Pro-Link Ti Stand Alone Cervical Spacer System - K180642 |

# Device Description:

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces have been acid etched through a previously cleared process called nanoLOCK™ (MMN™) to improve fixation to the adjacent bone.

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The purpose of this special 510(k) submission is to add a plate to the Endoskeleton® TCS System. The ENDOSKELETON® TCS Plate Device (Plate) is compatible with the ENDOSKELETON® TCS Interbody Fusion Device product family. The design incorporates a locking screw to secure the Interbody Fusion Device and is engaged after the placed on the anterior face of the ENDOSKELETON® TCS Interbody Fusion Device to resist the integrated screws from backing out. The system includes a holding feature on the Plate to mate with the inserter to facilitate placement onto the ENDOSKELETON® TCS Interbody Fusion Device implant. Use of this plate is an enhancement to the existing Endoskeleton® TCS system and, as such, is optional with the Endoskeleton® TCS Interbody Fusion Device and does not qualify as supplemental fixation. The subject plate does not include nanoLOCK® (MMN™) surface treatment, as it does not interface with the bone.

The construct is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-EL)) and may be provided either sterile. The subject Endoskeleton® TCS Plate is only provided sterile by gamma irradiation.

## Indication for Use:

The ENDOSKELETON® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/or corticocancellous bone. The device is a stand-alone system when used with ENDOSKELETON® TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

#### Substantial Equivalence:

The subject Endoskeleton® TCS IBD is substantially equivalent to the following:

Primary Predicate: Titan Spine - Endoskeleton® TCS Interbody Fusion Device (K142940, S.E. 01/28/2015; K153122, 12/14/2015; S.E. K173535, S.E. 02/13/2018; and K183557; S.E. 02/11/2019).

Secondary Predicate: Life Spine Pro-Link Ti Stand Alone Cervical Spacer System (K180642, S.E. 05/10/2018)

The subject Endoskeleton® TCS Plate is manufactured from titanium (Ti6Al4V ELI) and is intended to be used as an intervertebral body fusion device only in conjunction with the Endoskeleton® TCS IBDs and Integrated Screws, similar to the predicate devices. The subject plate also shares similar indications for use, geometry, and construction with the predicate devices

Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

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#### Performance Testing:

Performance bench testing, including locking plate resistance to screw push-out and retention force of the plate holder, was performed to demonstrate substantial equivalence.

#### Conclusion:

Based upon the information contained in this submission and the similarities of the subject and predicate devices, the subject Endoskeleton® TCS Interbody Fusion Deviceis substantially equivalent to the predicate devices.