Xenco Medical Cervical Interbody System

K160313 · Xenco Medical, LLC · OVE · Oct 21, 2016 · Orthopedic

Device Facts

• Record ID: K160313
• Device Name: Xenco Medical Cervical Interbody System
• Applicant: Xenco Medical, LLC
• Product Code: OVE · Orthopedic
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as an intervertebral fusion device with bone graft, cervical: Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system). When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover): Xenco Medical Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xenco Medical Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

Device Story

The Xenco Medical Cervical Interbody System is an intervertebral body fusion device designed for cervical spine surgery. It consists of an interbody spacer, which is packed with autogenous bone graft to facilitate fusion. The system is used in two configurations: as a spacer requiring supplemental anterior plate fixation, or as a stand-alone construct including an integrated plate, bone screws, and a locking cover. The device is implanted by a surgeon via an open, anterior approach in a clinical/hospital setting. It provides structural support to the disc space to promote spinal fusion in patients with degenerative disc disease. By stabilizing the vertebral segment, the device aims to alleviate discogenic neck pain and restore spinal alignment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Intervertebral body fusion device; includes interbody spacer, plate, bone screws, and locking cover. Designed for anterior cervical implantation. Materials and specifications are consistent with standard orthopedic interbody fusion devices.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic neck pain confirmed by history/radiography) at one level (C3-C7) of the cervical spine. Requires 6 weeks of prior non-operative treatment. Used with autogenous bone graft via open anterior approach. May be used with supplemental fixation or as a stand-alone construct with provided plate, screws, and locking cover.

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.

Submission Summary (Full Text)

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

October 21, 2016

Xenco Medical, LLC Gustavo Prado, Ph.D. Vice President of R&D 9930 Mesa Rim Road San Diego, California 92121

Re: K160313

Trade/Device Name: Xenco Medical Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, ODP Dated: September 27, 2016 Received: September 28, 2016

Dear Dr. Prado:

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 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.

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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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## Indications for Use

510(k) Number (if known) K160313

Device Name Xenco Medical Cervical Interbody System

#### Indications for Use (Describe) When used as an intervertebral fusion device with bone graft, cervical:

Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):

Xenco Medical Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xenco Medical Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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