X-Pac Expandable Lumbar Cage System

K201145 · Expanding Innovations, Inc. · MAX · Sep 10, 2020 · Orthopedic

Device Facts

• Record ID: K201145
• Device Name: X-Pac Expandable Lumbar Cage System
• Applicant: Expanding Innovations, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as 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). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

Device Story

The X-Pac Expandable Lumbar Cage System is an intervertebral body fusion device used in lumbar spinal surgery. The system consists of an expandable cage implant and associated surgical instruments. The implant is placed via a transforaminal approach following a discectomy to provide structural stability and facilitate spinal fusion when used with autogenous bone graft. The cage features superior and inferior surface protrusions to grip vertebral endplates and resist expulsion. It allows for intraoperative adjustment in both parallel and lordotic configurations to accommodate patient anatomy. The device is used by surgeons in a clinical/OR setting. The system is intended for use with FDA-cleared supplemental fixation systems. The primary benefit is the restoration of disc height and stabilization of the spinal segment in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Performance testing included mechanical verification and validation in accordance with ASTM F2077 (compression and compressive shear), ASTM F2267 (subsidence), and expulsion testing to demonstrate substantial equivalence.

Technological Characteristics

Implants manufactured from medical grade titanium alloy (ASTM F136, ASTM F1295). Expandable cage design with parallel and lordotic adjustment capabilities. Single-use implants; reusable surgical instruments. Both require cleaning and steam sterilization. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease at one or two contiguous lumbar levels (L2-S1) with discogenic back pain, failing 6 months of non-operative treatment; may include up to Grade 1 spondylolisthesis or retrolisthesis.

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

• X-Pac Expandable Lumbar Cage System (K152539)
• X-Pac Expandable Lumbar Cage System (K160856)
• Endoskeleton TT (K083714)

Submission Summary (Full Text)

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September 10, 2020

Expanding Innovations, Inc. % Ms. Nancy Lincé Regulatory Affairs Consultant Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 95483

Re: K201145

Trade/Device Name: X-Pac Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 7, 2020 Received: August 10, 2020

Dear Ms. Lincé:

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,

Brent Showalter, Ph.D. 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) K201145

Device Name

Expanding Innovations X-Pac Expandable Lumbar Cage System

Indications for Use (Describe)

The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion.

The system is intended for use in patients with degenerative disc disease (defined as 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). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

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

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### A. Name, Address, and Phone Number of Applicant

Expanding Innovations, Inc. 110 Pioneer Way, Suite I Mountain View, CA 94041 Phone: [phone]

#### B. Contact Person

Nancy Lincé Regulatory Affairs Consultant Lincé Consulting, LLC

#### C. Date Prepared

August 7, 2020

#### D. Device Name and Classification

| Trade Name: | Expanding Innovations X-Pac Expandable Lumbar Cage System |
|-------------------------|-----------------------------------------------------------|
| Common Name: | Intervertebral Body Fusion Device |
| Classification<br>Name: | Intervertebral Body Fusion Device-Lumbar |
| Regulation #: | 21 CFR§888.3080 |
| Product Code: | MAX |

#### E. Primary Predicate Device

The Expanding Innovations X-Pac Expandable Lumbar Cage System is substantially equivalent to the previously cleared X-Pac Expandable Lumbar Cage System, K152539 and K160856.

#### ட் Additional Predicate Device

Titan Spine Inc., Endoskeleton TT, K083714

#### G. Device Description

The X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and

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are placed via the transforaminal approach. The device is available in different sizes and footprints, to accommodate varying patient anatomy, and is designed to allow for intraoperative adjustment in both the parallel and lordotic configurations. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295. The Expanding Innovations X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this Special 510(k).

#### H. Indications for Use / Intended Use

The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion.

The system is intended for use in patients with degenerative disc disease (defined as 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). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

#### l. Technological Comparison

The technological characteristics of the Expanding Innovations X-Pac Expandable Lumbar Cage System implants are substantially equivalent to the predicate in terms of intended use, indications for use, overall design, function, technology, materials, and performance.

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#### J. Performance Data

A risk assessment, including mechanical testing, was conducted to confirm that the new cage sizes not introduce new issues of safety or effectiveness. The new cage sizes successfully underwent performance testing including verification and validation testing and mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms; ASTM F2267 for subsidence testing; and expulsion testing. The mechanical performance tests were based on well-recognized test methods for interbody fusion devices, including those outlined in Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Test results demonstrate substantial equivalence to the predicate device.

#### K. Basis for Substantial Equivalence

The modified X-Pac Expandable Lumbar Cage System is identical to the predicate with respect to intended use, indications for use, overall design, function, technology, materials, and performance as well as procedural steps, surgical instrumentation, and product labeling. The information provided supports the substantial equivalence of the modified X-Pac Expandable Lumbar Cage System to the legally marketed predicate devices.