X-Pac Expandable Lumbar Cage System

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March 24, 2022 Expanding Innovations, Inc % Carolyn Guthrie Director of QA/RA Kapstone Medical, LLC 510 Elliot Street Charlotte, North Carolina 28202 Re: K220655 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: March 4, 2022 Received: March 7, 2022 Dear Ms. Guthrie: 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. 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Sincerely. for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220655 ### Device Name 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Special 510(k) Notification X-Pac Expandable Lumbar Cage System # 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, Phone, and Fax Number of Applicant Expanding Innovations, Inc. 110 Pioneer Way, Suite 1 Mountain View, CA 94041 Phone: (925)-819-2257 #### B. Contact Person Katelyn Jessup Regulatory Affairs Consultant Kapstone Medical, LLC #### C. Date Prepared March 1, 2022 #### Device Name and Classification D. | Trade Name: | X-Pac Expandable Lumbar Cage System | |----------------------|-------------------------------------| | Common Name: | Intervertebral Body Fusion Device | | CFR Classification: | 21 CFR§888.3080 | | Classification Name: | Intervertebral Body Fusion Device | | Product Code: | MAX | #### E. Predicate Device The Expanding Innovations X-Pac Expandable Lumbar Cage System is substantially equivalent to the previously cleared Expanding Innovations X-Pac Expandable Lumbar Cage System, K152539, K160856, K201145 and K203802. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for Expanding Innovations. The logo has the word "Expanding" in blue, with a red dotted line extending from the left side of the "E" to the bottom of the "g". Below "Expanding" is the word "Innovations" in a smaller font, also in blue. #### F. Device Description The Expanding Innovations 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 are placed via the transforaminal approach. The device is available in various sizes and footprints to accommodate varying 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 F1472. 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 surqical instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this Special 510(k). #### Indications for Use / Intended Use G. 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Expanding Innovations. The logo features the word "Expanding" in a bold, blue font, with a series of red dots arching over the word. Below "Expanding" is the word "Innovations" in a smaller, gray font. #### H. 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. #### l. Performance Data A risk assessment, including mechanical testing, was conducted to confirm that the new cage sizes do not introduce new issues of safety or effectiveness. The new cage sizes successfully underwent performance testing including mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms. 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. #### J. 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.