SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. April 30, 2020 SpineEX, Inc. Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 Re: K200816 Trade/Device Name: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 27, 2020 Received: March 30, 2020 Dear Mr. Wright: 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, Brent Showalter, Ph.D. Acting 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) K200816 #### Device Name SpineEX Sagittae® Lateral Lumbar Interbody Fusion System #### Indications for Use (Describe) The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. 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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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Submitter's Name: | SpineEX, Inc. | |----------------------------|------------------------------------------------------------------------------------------| | Submitter's Address: | 4046 Clipper Court<br>Fremont, CA 94538 | | Submitter's Telephone: | 510-573-6165 | | Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>719-351-0248<br>nwright@empiricaltech.com | | Date Summary was Prepared: | 27-Mar-2020 | | Trade or Proprietary Name: | SpineEX Sagittae® Lateral Lumbar Interbody Fusion<br>Devices | | Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar | | Classification: | Class II per 21 CFR §888.3080 | | Product Code: | MAX | | Classification Panel: | Division of Orthopedic Devices | # DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively. ## INDICATIONS FOR USE The SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The indications for use for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are identical to the previously cleared SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices under K181531 and K190193. {4}------------------------------------------------ # TECHNICAL CHARACTERISTICS The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: - . Indications for use - Materials of manufacture - Structural support mechanism ● - Principles of operation ## Table 5-1 Predicate Devices | 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate | |------------------|--------------------------------------------------------------|---------------|-----------| | K181531, K190193 | SpineEX Sagittae® Lateral Lumbar<br>Interbody Fusion Devices | SpineEX, Inc. | Primary | # PERFORMANCE TESTING SUMMARY Minor design modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices cleared under K181531 and K190193 have been evaluated mechanically through performance testing per ASTM F2077. # CONCLUSION The subject modified SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are very similar to previously cleared SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The subject has identical uses, indications, technological characteristics, and principles of operation as the predicate device. The modifications raise no new types of safety or efficacy questions. The overall technology characteristics lead to the conclusion that SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is substantially equivalent to the predicate device.