Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

{0}------------------------------------------------ September 28, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. LESspine Innovations % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs. Colorado 80918 ### Re: K232605 Trade/Device Name: Sacrix® Sacroiliac Joint Fusion Device System. Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, PEK, KWO, MRW Dated: August 25, 2023 Received: August 28, 2023 Dear Nathan 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, Colin DA O'neill -S Colin O'Neill, M.B.E. 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) ### K232605 Device Name Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System ndications for Use (Describe) The Sacrix® Sacroillac Joint Fusion Device System is intended for fusion of the sacroillac joint for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudloarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and reoperation for failed fusion or instability following surgery for above indications. The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/ or dislocations: 2) Spondylolisthesis: 3) Spondylolysis: 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {5}------------------------------------------------ # 510(K) SUMMARY | Submitter's Name: | LESspine Innovations | | |--------------------------------|----------------------------------------------------------------------------------------------|--| | Submitter's Address: | 350 Main Street<br>Malden, Massachusetts 02148 | | | Submitter's Telephone: | 978-232-3990 | | | Contact Person: | Nathan Wright MS, RAC<br>Empirical Technologies<br>719-351-0248<br>nwright@empiricaltech.com | | | Date Summary was Prepared: | August 25, 2023 | | | Trade or Proprietary Name: | Sacrix® Sacroiliac Joint Fusion Device System | | | Device Classification Name: | Sacroiliac Joint Fixation | | | Classification & Regulation #: | Class II per 21 CFR §888.3040 | | | Product Code: | OUR | | | Trade or Proprietary Name: | Inspan® ScrewLES Fusion System | | | Device Classification Name: | Spinous Process Plate | | | Classification & Regulation #: | Class II per 21 CFR §888.3050 | | | Product Code: | PEK | | | Trade or Proprietary Name: | Invue® MAX™ + Invue Inset Anterior Cervical Plate System | | | Device Classification Name: | Appliance, Fixation, Spinal Intervertebral Body | | | Classification & Regulation #: | Class II per 21 CFR §888.3060 | | | Product Code: | KWQ | | | Trade or Proprietary Name: | FacetFuse® Screw Fixation System | | | Device Classification Name: | System, Facet Screw Spinal Device | | | Classification & Regulation #: | Unclassified | | | Product Code: | MRW | | | Classification Panel: | Orthopedic - Spinal (DHT6B) | | ## Description of the Device Subject to Premarket Notification: The Sacrix® Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy, Ti-6AI-4V ELI per ASTM F136. Solid and Fenestrated Screws have a cannulated core to allow packing of allograft or autograft material. Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall. The Inspan® ScrewLES Fusion System consists of a variety of sizes of plates, set screws, and associated instruments. The plates are offered in five hub diameters (8 mm in 2 mm increments) and five wing length configurations (35 mm to 47 mm increments). The device height (measured from the base of the central hub to the top of the wing) is fixed across all configurations at 18.85 mm for InSpan® and 13.89 mm for InSpan® Slim. Spikes are present on the sides of the plate that interface with the spinous process to restrain the {6}------------------------------------------------ plate from rotating post-operatively. The components of the Inpan® ScrewLES Fusion System are fabricated from medical grade titanium alloy Ti-6AI-4V ELI per ASTM F136. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System consists of a variety of shapes and sizes of plates, screws, and the associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The one level plates have lengths ranging from 17 mm in 2 mm increments, two level plates range from 33 mm in 2 mm increments, three level plates range from 48 mm to 78 mm in 3 mm increments, and the four-level plates range from 61 mm in 4 mm increments. A lock is integrated in the plate and screw to secure the screw from backout. Ø4.2 mm self-drilling screws and Ø4.5 mm self-tapping screws are offered. All screws are offered in lengths of 12 mm, 16 mm, 18 mm, and 20 mm. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System components are single use and are fabricated from titanium alloy Ti-6AI-4V ELI per ASTM F136. The FacetFuse® Screw Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The FacetFuse® Screw Fixation System offers partially threaded screws. The partially threaded screws are available in Ø4.5 mm diameter screw (in 0.5 mm increments) offered in lengths of 25 mm to 50 mm (in 5 mm increments). The fully threaded screws are available in diameters Ø4.5 mm and Ø5.0 mm in lengths from 20 mm in 5 mm increments. The device is fabricated from titanium alloy Ti-6Al-4V ELI per ASTM F136. The devices are offered with a built in washer or without a washer. The washers are intended to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories. The purpose of this submission is to offer sterile packaged options of each implant. # INDICATIONS FOR USE The Sacrix® Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications. {7}------------------------------------------------ The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm. # TECHNOLOGICAL CHARACTERISTICS The subject and predicate devices have the same technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are the same between the subject and predicates: - . Indications for Use - . Materials of manufacture - . Structural Support Mechanisms - . Design Features The sterile packaging was validated to mitigate any risk of the change in sterilization method. #### Sacrix® Sacroiliac Joint Fusion System Device Predicate Devices | 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type | |-------------|------------------------------------------------|----------------------|----------------| | K150017 | Sacrix® Sacroiliac Joint Fusion Device System | LESspine Innovations | Primary | | K021932 | Synthes 6.5 mm Cannulated Screw | Synthes (USA) | Additional | | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | CoreLink, LLC | Additional | #### Inspan® ScrewLES Fusion System Predicate Devices | 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type | |-------------|------------------------------------|----------------------|----------------| | K213266 | InSpan ScrewLES Fusion System | LESspine Innovations | Primary | #### Invue® MAX™ + Invue Inset Anterior Cervical Plate System Predicate Devices | 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type | |-------------|-----------------------------------------|---------------------|----------------| | K121060 | SpineFrontier Indus™ | LESspine Innovation | Primary | | K093776 | Indus™ Anterior Cervical Plate System | LESspine Innovation | Additional | | K163104 | Terrace™ Anterior Cervical Plate System | CoreLink, LLC | Additional | #### FacetFuse® Screw Fixation System Predicate Devices | 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type | |-------------|---------------------------------------|----------------------|----------------| | K071420 | Chameleon FacetFuse MIS Screw System | LESspine Innovation | Primary | | K211855 | Ion Facet Screw System | SurGenTec, LLC | Additional | | K131471 | Facet FixxTM | Nexxt Spine | Additional | | K012773 | Discovery Facet Screw Fixation System | DePuy AcroMed™, Inc. | Additional | ### PERFORMANCE DATA The Sacrix® Sacroiliac Joint Fusion Device System has previously been tested under its previous clearance in the following test modes: {8}------------------------------------------------ - . Static axial pull out per ASTM F543 - . Static three-point bending per ASTM F2193 - Dynamic three-point bending per ASTM F2193 . The Inspan® ScrewLES Fusion System has previously been tested under its previous clearance in the following test modes: - . Static compression bending per ASTM F1717 - Dynamic compression bending per ASTM F1717 ● - . Torsion testing per ASTM F1717 The Invue® MAX™ + Invue Inset Anterior Cervical Plate System has previously been tested under its previous clearance in the following test modes: - . Static compression bending per ASTM F1717 - Dynamic compression bending per ASTM F1717 . - Torsion testing per ASTM F1717 ● The FacetFuse® Screw Fixation System has previously been tested under its previous clearance to meet the performance standards of ASTM F2193 and ASTM F543. The results of these non-clinical tests showed that each system is substantially equivalent to legally marketed predicate devices. The changes in sterilization and packaging do not affect mechanical performance and require no additional bench testing for this submission. ### CONCLUSION The overall technology characteristics and mechanical performance data lead to the Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue@ MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System are substantially equivalent to the predicate devices.