Endoskeleton TCS Interbody Fusion Device

K151596 · Titan Spine, LLC · OVE · Oct 9, 2015 · Orthopedic

Device Facts

• Record ID: K151596
• Device Name: Endoskeleton TCS Interbody Fusion Device
• Applicant: Titan Spine, LLC
• Product Code: OVE · Orthopedic
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain 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 pror to treatment with the device is indicated to be used with autograft bone. The device 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.

Device Story

Anterior cervical intervertebral body fusion device; titanium alloy (Ti-6Al-4V-ELI) implant; hollow center for autograft bone; acid-etched superior/inferior surfaces for bone fixation. Used in single-level cervical fusion; stand-alone system when used with integrated screws; requires supplemental fixation if screws are not used. Implanted by surgeons in clinical settings. Modification includes updated screw hex size (T6 to T8) and adjusted screw heights (13–21.35mm). Device provides structural support to disc space to facilitate fusion; benefits patients by stabilizing cervical spine segments affected by degenerative disc disease.

Clinical Evidence

No clinical data; engineering rationale provided.

Technological Characteristics

Medical grade titanium alloy (Ti-6Al-4V-ELI); acid-etched surfaces; stand-alone interbody fusion system with integrated screws; mechanical fixation; non-software device.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one cervical level (C2-T1) who have failed 6 weeks of non-operative treatment. Used with autograft 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 (K142940)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 9, 2015

Titan Spine, LLC. % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove, Bartlett, Tennessee 38133

Re: K151596

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, ODP Dated: September 3, 2015 Received: September 8, 2015

Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known)

K151596

Device Name

Endoskeleton(R) TCS Interbody Fusion Device

#### Indications for Use (Describe)

The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain 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 pror to treatment with the device is indicated to be used with autograft bone. The device 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

> K151596 Page 1 of 1

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### 510(k) Summary

Endoskeleton® System October 6, 2015

| Company: | Titan Spine, LLC<br>6140 West Executive Drive, Suite A<br>Mequon, WI 53092, USA |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | 3006340236 |
| Primary Contact: | Christine Scifert<br>Phone: [phone] |
| Company Contact: | Jane Rodd<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Endoskeleton® TCS Interbody Fusion Device |
| Common Name: | Intervertebral Body Fusion Device with Integrated Fusion Cervical<br>Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | 87- Orthopedic |
| Product Code: | OVE ODP |
| Primary Predicate: | Titan Spine Endoskeleton® TCS (K142940 S.E. January 28, 2015) |

## 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 are acid etched to improve fixation to the adjacent bone.

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The device 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-6AI-4V-ELI).

The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 – 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update.

## Indications for Use:

The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck 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 is indicated to be used with autograft bone. The device 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.

## Substantial Equivalence:

The subject Endoskeleton® TCS IBD is substantially equivalent to Titan Spine's previously cleared Endoskeleton® TCS IBD (K142940 S.E. January 28, 2015).

The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 - 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update. The Indications for Use, materials, and geometry of the IBD devices and the locking collar are identical to the predicate devices. An engineering rationale was provided in lieu of performance testing because these modifications do not impact the overall function of the device and the screw thread length is identical to the predicate. The change in height is due to a small increase in the height of the screw, which does not impact testing. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.