What is the FDA product code for Spineology Interbody Fusion System?

OQB. It is classified under 21 CFR 888.3085 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Spineology Interbody Fusion System?

De Novo classification (submission type: Direct).

Who can help prepare an FDA De Novo submission like Spineology Interbody Fusion System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA De Novo submissions. See https://innolitics.com/services/regulatory/ or contact https://innolitics.com/contact.

Spineology Interbody Fusion System

Q: Who is the manufacturer of Spineology Interbody Fusion System?

Spineology, Inc. filed the De Novo classification request for Spineology Interbody Fusion System (DEN200010).

DEN200010 · Spineology, Inc. · OQB · Sep 18, 2020 · Orthopedic

Device Facts

Record ID	DEN200010
Device Name	Spineology Interbody Fusion System
Applicant	Spineology, Inc.
Product Code	OQB · Orthopedic
Decision Date	Sep 18, 2020
Decision	DENG
Submission Type	Direct
Regulation	21 CFR 888.3085
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

Device Story

The Spineology Interbody Fusion System (SIFS) is a non-rigid, implantable PET mesh bag designed to contain bone graft (allograft/autograft) within the intervertebral space. The device is inserted into the prepared disc space using specialized instruments (Mesh Holder, Mesh Extender, Fill Tube, Cinch String Cutter) and then packed with graft material. The SIFS construct is used in conjunction with supplemental posterior pedicle screw fixation. The device is intended for use by surgeons in a clinical/OR setting to facilitate spinal fusion in patients with degenerative disc disease. By containing the graft, the device provides a stable environment for bone fusion, potentially reducing pain and improving function for the patient.

Clinical Evidence

Special controls require clinical performance testing to include an assessment of adverse events and intervertebral body fusion rates compared to a clinically acceptable fusion rate.

Technological Characteristics

Non-rigid, implanted spinal device; designed to contain bone graft within an internal cavity. Requires biocompatibility, mechanical durability, and deployment/filling validation. Must be used with supplemental posterior fixation. Specific materials and engineering schematics are subject to special controls.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one lumbar level (L2-S1) who have failed 6 months of conservative care.

Regulatory Classification

Identification

An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must include an assessment of any adverse events observed during clinical use, as well as intervertebral body fusion, and compare this to a clinically acceptable fusion rate. (2) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant, as well as the ability of the device to be inserted, deployed, and filled with bone graft consistently. (3) Device must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components, and device-specific instruments. (5) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (6) Labeling must bear all information required for the safe and effective use of the device, specifically including the following: (i) A clear description of the technological features of the device including identification of device materials, compatible components in the fusion construct, and the principles of device operation; (ii) Intended use and indications for use, including levels of fixation; (iii) Identification of magnetic resonance (MR) compatibility status; (iv) Cleaning and sterilization instructions for devices and instruments that are provided nonsterile to the end user; and (v) Detailed instructions of each surgical step, including device removal.

Related Devices

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K112986 — LATERAL FUSION DEVICE · Integra Spine (Integra Lifesciences) · May 1, 2012
K192132 — SeaSpine Beachside System · SeaSpine Orthopedics Corporation · Dec 3, 2019
K141665 — NuVasive CoRoent System · Nuvasive, Inc. · Mar 13, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ ### DE NOVO CLASSIFICATION REQUEST FOR SPINEOLOGY INTERBODY FUSION SYSTEM #### REGULATORY INFORMATION FDA identifies this generic type of device as: Intervertebral body graft containment device. An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion. NEW REGULATION NUMBER: 21 CFR 888.3085 CLASSIFICATION: Class II PRODUCT CODE: OQB ### BACKGROUND DEVICE NAME: Spineology Interbody Fusion System SUBMISSION NUMBER: DEN200010 DATE DE NOVO RECEIVED: February 19, 2020 #### SPONSOR INFORMATION: Spineology, Inc. 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128 #### INDICATIONS FOR USE The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine. {1}------------------------------------------------ # LIMITATIONS The sale, distribution, and use of the Spineology Interbody Fusion System are restricted to prescription use in accordance with 21 CFR 801.109. PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. ## DEVICE DESCRIPTION ### Implant Description: The Spineology Interbody Fusion System (SIFS) is a lumber intervertebral body fusion device comprised of a PET (polyethylene terephthalate) mesh bag designed to contain compatible allograft and autograft as an adjunct to fusion for the treatment of degenerative disc disease (see Figure 1). The device is placed into the prepared intervertebral disc space and then is packed with bone graft. The resulting SIFS implant is used with posterior supplemental fixation forming the completed SIFS construct (see Figure 2). Image /page/1/Picture/6 description: The image shows two different SIES implants. The left side of the image shows an unfilled SIES implant, while the right side shows a SIES implant filled with a bone graft. Both implants are white and have a mesh-like structure. The filled implant appears to be more rounded and full compared to the unfilled implant. Figure 1: Unfilled SIFS implant (left), SIFS implant filled with bone graft (left) Image /page/1/Picture/8 description: This image shows a SIFS construct with pedicle screw fixation. The construct is made of two blue blocks connected by a silver rod. The screws are inserted into the pedicles of the vertebrae to stabilize the spine. The image is labeled as Figure 2. {2}------------------------------------------------ # Instrument Description: The instruments in Table 1, below, and Class I surgical instruments under 21 CFR 888.4540, product code LXH, are provided to implant the SIFS device in the lumbar spine. | Name | Function | Image | |---------------------|------------------------------------------------------------------------------------------------|----------------------------| | Mesh Holder | delivery of the device to prepared space; also holds fill tubes during graft delivery | Image: Mesh Holder | | Mesh Extender | used for initial device placement into disc space | Image: Mesh Extender | | Fill Tube | used to hold and deliver graft material | Image: Fill Tube | | Cinch String Cutter | used to cut the drawstrings of the device | Image: Cinch String Cutter | Table 1: Instruments reviewed in DEN200010 as part of this device # SUMMARY OF NONCLINICAL/BENCH STUDIES ## BIOCOMPATIBILITY/MATERIALS The Spineology Interbody Fusion System is manufactured from the following materials: | Description | Material | Direct Patient Contact | Contact Duration | |-------------|----------------------------------|---------------------------|-------------------| | Implant | Polyethylene Terephthalate (PET) | Yes | Permanent (>30 d) | | Instruments | Stainless Steel | Yes | Limited (≤24 h) | Biocompatibility evaluation has been completed according to FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" # SHELF LIFE/STERILITY ## Gamma Sterilization: The subject implant and certain instruments are provided sterile to the end user. The sterilization method is gamma radiation at a dose of (b) (4). Sterilization was validated {3}------------------------------------------------ using the VDmax method as per ISO 11137 to ensure that a minimum Sterility Assurance Level (SAL) of 10to is achieved. Sterilized samples real-time aged to 5 years were used to determine the shelf life of the device. Distribution testing (ASTM D4169) and package integrity testing (bubble leak test, ASTM F2096), and seal strength testing (ASTM F88/F88M) were used to validate the sterile shelf life of the device. Non-clinical performance testing of the implant was used to assess the performance shelf life of the device. The testing confirmed a 5-year shelf-life. # Ethylene Oxide Sterilization: Certain subject instruments are provided sterile to the end user via ethylene oxide. This method has been validated in accordance with ISO 11135 to ensure that a minimum a Sterility Assurance Level (SAL) of 10-6 is achieved. Sterilized samples real-time aged to 5 years were used to determine the shelf life of the device. Distribution testing (ASTM D4169) and package integrity testing (bubble leak test, ASTM F2096), and seal strength testing (ASTM F88/F88M) were used to validate the sterile shelf life of device. The testing confirmed a 5-year shelf-life. ## Reprocessing: Certain subject instruments are provided non-sterile and are to be cleaned and sterilized by the end-user. Validated reprocessing instructions are included in their own separate labeling document. Steam sterilization method was validated per ISO 17665 and AAMI ST79 to ensure that a minium Sterility Assurance Level (SAL) of 10 ° is achieved. Instruments are to be sterilized using a Pre-vacuum steam autoclave. For the pre-vacuum steam autoclave cycle, the validated parameters call for an exposure time of 4 minutes at 270°F (132°C) and a dry time of 30 minutes at 270°F (132°C). Users are advised to use an FDA- cleared sterilization wrap. # MAGNETIC RESONANCE (MR) COMPATIBILITY The SIFS implant is a non-ferromagnetic, polymeric device made of PET. The subject device was not evaluated for safety and compatibility in a Magnetic Resonance Environment. | Test | Purpose | Method | Performance Criteria | Results | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Burst Test | Evaluate mechanical properties of the bone graft containment device under a compressive load | PET sheets are placed between the top and bottom ring clamp of burst test fixture without tension. A load is applied until failure. | The performance criteria was based on the Sponsor historical batch/lot records | The PET sheets were tested to failure. The report included the bursting strength of each specimen and the average bursting strength for each | | Test | Purpose | Method | Performance Criteria | Results | | Tensile and Elongation Test | Evaluate mechanical properties of the mesh material under a tensile load | The test methodology was adapted from ASTM D3787. PET tubes are mounted in clamps of the tensile testing machine and a force applied until failure. Elongation is expressed as a ratio of the extension of a material to the length of the material prior to stretching. The test methodology was adapted from ASTM D5034. | The performance criteria was based on the Sponsor historical batch/lot records | The PET tubes were tested to failure. The report included the tensile strength and elongation of each specimen and the average tensile strength and elongation for each specimen along with the standard deviation. | | Static Axial Compression | Evaluate mechanical properties of the bone graft containment device when filled with bone graft under Static Axial Compression loading | The SIFS implant filled with representative bone graft were tested under static compression until failure or approximately (b) (4) N was reached. The test methodology is in accordance with ASTM F2077. Additionally, pre- and post- test dimensions (height, width, and length) and mass of the device was taken to characterize the deformation of the device. | There was no pre-determined performance criteria for this test. | The tested device deformed under the applied load and post- test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the force-displacement graphs. The linear equations used to calculate stiffness was also provided. | | Dynamic Axial Compression | Evaluate mechanical properties of the bone graft containment device when filled with bone graft under Dynamic Axial Compression loading | The SIFS implant filled with representative bone graft were tested under dynamic compression to (b) million cycles at Hz. The test methodology is in accordance with ASTM F2077. Additionally, pre- and post- test dimensions (height, width, and length) and mass of the device was taken to characterize the deformation of the device. | There was no pre-determined performance criteria for this test. | The tested device deformed under the applied load and post- test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the cycle-displacement table. | | Static Compression Shear | Evaluate mechanical properties of the bone graft containment device when filled with bone graft under Static Compression- shear loading | The SIFS implant filled with representative bone graft were tested under static compression-shear (b)(4)(o) until failure or approximately (b) (4) N was reached. The test | There was no pre-determined performance criteria for this test. | The tested device deformed under the applied load and post- test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test | | Test | Purpose | Method | Performance Criteria | Results | | | | methodology is in accordance with ASTM F2077. Additionally, pre- and post- test dimensions (height, width, and length) and mass of the device was taken to characterize the deformation of the device. | | images were provided along with the force-displacement graphs. The linear equations used to calculate stiffness was also provided. | | Dynamic Compression Shear | Evaluate mechanical properties of the bone graft containment device when filled with bone graft under Dynamic Compression-shear loading | The SIFS implant filled with representative bone graft were tested under dynamic compression to(b) million cycles at(b) Hz. The test methodology is in accordance with ASTM F2077. Additionally, pre- and post- test dimensions (height, width, and length) and mass of the device was taken to characterize the deformation of the device. | There was no pre-determined performance criteria for this test. | The tested device deformed under the applied load and post- test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided. | | Subsidence | Evaluate mechanical properties of the bone graft containment device when filled with bone graft. Evaluates the implants resistance to subsidence. | The SIFS implant filled with representative bone graft were tested per ASTM F2267. Additionally, pre- and post- test dimensions (height, width, and length) and mass of the device was taken to characterize the deformation of the device. | There was no pre-determined performance criteria for this test. | The tested device deformed under the applied load and post- test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided. The stiffness and yield were reported. | | Expulsion | Evaluate mechanical properties of the bone graft containment device when filled with bone graft. Evaluates the migration potential. | The SIFS implant filled with representative bone graft were placed in polyurethane foam blocks with a compressive pre- load of(b) (4) N. A load was applied until the specimen was displaced. | There was no pre-determined performance criteria for this test. | The report included the force required to displace the device along with the representative pre- and post- test images. | | Wear Particulate Analysis | Evaluate the wear debris of the of the bone graft containment device when filled with bone graft. | A wear testing protocol for collection and analyses were conducted based on ISO 17853, ASTM F1877, and ASTM F2025. | There was no pre-determined performance criteria for this test. | The particulates size and morphological characteristics, as well as associated elemental constituents, were reported. | | Test | Purpose | Method | Performance Criteria | Results | | Simulated Fill Testing | Evaluate the consistency and mechanical features of the bone graft containment device when filled with bone graft by different personnel | Personnel were instructed to fill the SIFS implant with representative bone graft per the protocol. The filled specimens were evaluated under Static Axial compression to evaluate the mechanical properties. Additionally, pre- and post- test dimensions (height, width, and length) and mass of the device was taken to characterize the deformation of the device. | The device is filled consistently and repeatedly across multiple users. | The mechanical properties of this group were compared to the mechanical properties of the experienced group. The specimens deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the force-displacement graphs. The linear equations used to calculate stiffness was also provided. | ## PERFORMANCE TESTING - BENCH {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ # SUMMARY OF CLINICAL INFORMATION ## Study Objective: The purpose of the clinical trial was to demonstrate the safety and effectiveness of the SIFS implant in instrumented lumbar intervertebral body fusion procedures. # Study Design: Spineology conducted a 24-month, prospective, single arm, multi-center study (G140140) which was based on their previously conducted prospective, randomized, multi-center study for the same device (G030106). The study enrolled and treated (0) subjects across "" clinical sites based on inclusion/exclusion criteria. Candidate subjects were skeletally mature adults with low back pain and pain-related disability, who presented with symptomatic single level degenerative disc disease between L2 and S1. The study was designed to meet a pre-determined performance goal at 24 months post-implantation which was based on their previously conducted prospective, randomized, multi-center study. Inclusion/Exclusion Criteria: | Inclusion Criteria | Exclusion Criteria | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Minimum age of twenty-one (21) years but not greater than eighty (80) years; | • Previous implant surgery (i.e., fusion procedure or total disc replacement) at the index level (Note: Previous less invasive procedures such as laminectomy, discectomy, etc., at the index level are not considered exclusionary); | | • Skeletally mature; | • Greater than Grade I spondylolisthesis; | | • Have a confirmed diagnosis of lumbar degenerative disc disease requiring single-level fusion between L2 and S1. Lumbar DDD diagnosis confirmation shall be determined by subject history, physical examination, and radiographic studies with one or more of the following factors: - Instability as defined by >3mm translation or | • Presents with a diagnosis of symptomatic non- index level lumbar degenerative disc disease between L2 and S1. Non-index level lumbar DDD diagnosis confirmation shall be determined by subject history, physical | | | | | ≥ 5° angulation; - Osteophyte formation of facet joints or vertebral endplates; - Decreased disc height, on average by > 2mm, but dependent upon the spinal level; - Scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; - Herniated nucleus pulposus; - Facet joint degeneration/changes; and/or - Vacuum phenomenon; • Report pre-operative low back pain score of ≥ 40mm on a 100mm Visual Analog Scale (VAS) correlating with involved level; • Report pre-operative Oswestry Disability Index (ODI) score of ≥ 40; • Received at least 6 months of conservative (non- surgical) treatment without sufficient relief from symptoms; • Willing and able to comply with follow-up evaluations per protocol, including completion of self-assessment survey questionnaire(s), and has read, understood and signed the sponsor and IRB approved site-specific informed consent form. | examination, and radiographic studies with one or more of the following factors: - Instability as defined by >3mm translation or ≥ 5° angulation; - Osteophyte formation of facet joints or vertebral endplates; - Decreased disc height, on average by > 2mm, but dependent upon the spinal level; - Scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; - Herniated nucleus pulposus; - Facet joint degeneration/changes; and/or - Vacuum phenomenon; • Active systemic infection or infection local to the surgical site; • Active or suspected malignancy; • Body Mass Index (BMI) of ≥ 40; • Significant metabolic bone disease (e.g., osteoporosis or osteomalacia) to a degree that would contraindicate spinal instrumentation. Osteoporosis is defined as a T-score of < -2.5 on a DEXA scan. A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimate), will be administered to identify those patients that require a DEXA scan (a score greater than or equal to 6 requires DEXA scan); • Taking medications that are known to potentially interfere with bone or soft tissues healing (e.g., chronic systemic steroids); • Has a current diagnosis of substance related disorder, as defined per the Diagnostic and Statistical Manual of Mental Disorders 5th Edition, May 2013 (DSM – V); • Has a diagnosis of somatoform, dissociative, eating or psychotic disorder per DSM – V; • Waddell Signs of inorganic behavior (3 or more signs); • Is a current tobacco user (current use defined as tobacco use ≤ 30 days prior to surgery); • Is a prisoner at the time of enrollment; | | • | If female: pregnant/contemplating pregnancy during the follow-up period; | | • | Enrolled in a concurrent clinical investigation that may confound the findings of the present investigation. | {7}------------------------------------------------ {8}------------------------------------------------ # Primary Endpoint: The primary endpoint used to evaluate the subjects implanted with the SIFS filled with compatible allograft and autograft when used with posterior supplementation for lumbar fusion consisted of the following elements (with accompanying success definitions): - Pain- Improvement in low back pain score as evidenced by a ""mm reduction on a ● (b) (4) mm Visual Analog Scale (VAS) when compared to baseline. - Function- Improvement in low back function as evidenced by a "" . -point decrease of the Oswestry Disability Index (ODI) score compared to baseline. - Fusion: Bridging bone demonstrated on CT Scan. - . Safety: Freedom from device-related Serious Adverse Events and secondary surgical interventions at the index level through the 24-month study interval. # Additional Endpoints: The following additional endpoints that were used to evaluate the safety and effectiveness are: - Mean low back VAS pain score over time through the 24-month interval. ● - Mean lower extremity (right and left leg) VAS scores over time through the 24-month ● interval. - Mean ODI score over time through the 24-month interval. - Fusion at the 12-month and the 24-month interval. - Occurrence of device-related Serious Adverse Events through the 24-month interval. ● - Occurrence of study-related Adverse Events through the 24-month interval. ● - Neurological status assessment (strength, sensation, and reflexes) over time through the ● 24-month interval (reporting categorized as improved, maintained, or reduced with new or increased neurological deficit being further categorized as transient (< 3 months/90 days) or longer term ≥ 3 months/90 days). - Radiographic data observed over time specific to the index level (translation, angulation, ● disc height, and device position). - Subject satisfaction with procedure/outcome. ● - . Work status over time. - . Pain medication use over time. - . Operative time. - Estimated blood loss. ● - Duration of hospitalization. ● - Graft site pain (as applicable). ● - Adjacent segment status at 24 months post-operative assessed by quantitative and ● qualitative radiographic data (translation, angulation, and disc height). {9}------------------------------------------------ # Subject Evaluation: Subjects were evaluated pre-operatively, intra-operatively, and immediately post-operatively followed by evaluations at 6 weeks, 3 months, 6 months, and 24 months. Additionally, longer-term patient questionnaires were completed at the 36- and 48- month interval until the final study subject achieved their 24-month study evaluation. The data collected at each evaluation time point is summarized in Table 1 below: | Assessment | Baseline | Surgery & Hosp. | 6-Week 42 days (± 7 days) | 3-Month 90 days (± 14 days) | 6-Month 180 days (± 30 days) | 12-Month 365 days (± 45 days) | 24-Month 730 days (± 60 days) | 36-Month & 48-Month as applicable (1095 & 1460 days ± 60 days each) | |----------------------------------|----------|--------------------|---------------------------------|-----------------------------------|------------------------------------|-------------------------------------|-------------------------------------|------------------------------------------------------------------------------------| | Inclusion/Exclusion | × | - | - | - | - | - | - | - | | Informed Consent | × | - | - | - | - | - | - | - | | Pain Medication Use | × | - | × | × | × | × | × | - | | Neurological Examination | × | × | × | × | × | × | × | - | | Surgery/Hospitalization | - | × | - | - | - | - | - | - | | Patient Survey1 | × | - | × | × | × | × | × | × | | Work Status | × | - | × | × | × | × | × | - | | MRI or other imaging study2 | × | - | - | - | - | - | - | - | | Weightbearing AP X-ray | × | × | × | × | × | × | × | - | | Weightbearing NL X-ray | × | × | × | × | × | × | × | - | | Weightbearing Flex/Ext X-rays | × | - | - | - | × | × | × | - | | CT scan | - | - | - | - | - | - | × | - | | Adverse Event Assessment | - | × | × | × | × | × | × | - | | Patient Questionnaire | - | - | - | - | - | - | - | × | | | | Table 1: Study Interval Data Collection | |--|--|-----------------------------------------| | | | | Patient Survey consists of VAS (low back, lower extremities, and liac crest as applicable), ODI, SF-36 Health Survey and subject satisfaction. +As defined per protocol. * Performed only if determined to be not fused per CT scan at the 12-month interval ## Subject Accountability and Demographics: Ten (0) (4) sites participated in the study with a total of (9) subjects enrolled and treated. Table 2 below provides an account of all subjects enrolled and treated in the study who completed the evaluations at each time point within the windows defined in the investigational protocol. {10}------------------------------------------------ | Exam | Theoretical # Due | Deaths Prior to Visit (Cumulative) | Withdrawals Prior to Visit (including death) | Expected Patients | Missed visit | Pending (Window not yet closed) | # Patients with any follow-up data evaluated | # Patients with complete data in-window | Calculation of follow-up rates (actual # seen/expected x 100) | |----------|-------------------|------------------------------------|----------------------------------------------|-------------------|--------------|---------------------------------|----------------------------------------------|-----------------------------------------|---------------------------------------------------------------| | Baseline | (b) (4) | | | | | | | | - | | Surgery | | | | | | | | | 100% (102/102) | | 6-Week | | | | | | | | | 98.0% (99/101) | | 3-Month | | | | | | | | | 100% (101/101) | | 6-Month | | | | | | | | | 96.0% (97/101) | | 12-Month | | | | | | | | | 98.0% (99/101) | | 24-Month | | | | | | | | | 95.0% (96/101) | | 36-Month | | | | | | | | | 68.2% (45/66) | | 48-Month | | | | | | | | | 73.7% (14/19) | # Table 2: Subject Accountability of the Investigational Cohort Through 48-Months *Includes the 3 subjects that had withdrawn early ** Includes the 4 subjects that had withdrawn early. {11}------------------------------------------------ Table 3 presents the demographic characteristics of the enrolled subjects. The mean age of the enrolled subjects was 57 years old, with 50% of the subjects being male and 50% of the subjects being female. Other demographic data, such as ethnicity, race, BMI and tobacco use, are reported in the table below. | Parameter | All Subjects Mean ± SD (N) (Median, Min, Max) Or ##/## (%) | |-------------------------------------|---------------------------------------------------------------| | Age at Consent (years) | $57.0\pm 12.0$ (102) 59.0 26.0 - 79.0 | | Gender | | | Male | 50.0% (51/102) | | Female | 50.0% (51/102) | | Ethnicity | | | Hispanic or Latino | 3.9% (4/102) | | Not Hispanic or Latino | 96.1% (98/102) | | Race | | | American Indian or Alaskan Native | 0.0% (0/100) | | Asian | 0.0% (0/100) | | Black or African American | 4.0% (4/100) | | Native Hawaiian or Pacific Islander | 0.0% (0/100) | | White | 96.0% (96/100) | | BMI | $30.6\pm 4.9$ (102) 29.9 20.0 - 39.9 | | Tobacco use | | | Current tobacco user (<30 days) | 0.0% (0/102) | | Previously but not now (>30 days) | 51.0% (52/102) | | Never | 49.0% (50/102) | Table 3: Demographic Characteristics of the Investigational Cohort Table 4 below shows the baseline assessments for VAS and ODI of the enrolled subjects. The mean VAS scores of all subjects (n=16) (0) at baseline for Low Back Pain, Right Leg Pain, and Left Leg Pain were(b) (4) and (b) (4)respectively. The mean ODI score of all subjects (n=(b) (4) at baseline was (b) (4) Table 4: Baseline Assessments (VAS, ODI) of the Investigational Cohort | Parameter | All Subjects Mean ± SD (N) (Median, Min, Max) | |--------------------|--------------------------------------------------| | VAS Low Back Pain | (b) (4) | | VAS Right Leg Pain | | | VAS Left Leg Pain | | {12}------------------------------------------------ | | (b) (4) | | | | |-----|---------|--|--|--| | | | | | | | ODI | | | | | Table 5 below summarized the intra-operative and hospital data collected on all subjects. A majority of the subjects (66.7% - (b) (4) were treated at L4-L5 followed by the L5-S1 level [0]41 of (b)(4)subjects). Mean operative time for all subjects (n= (0) (4)was 2.6 hours, and the mean estimated blood loss of all subjects (n=16) (4) was 137.3 cc. The predominant surgical approach (90.2% - (b) (4) was minimally invasive, and the medium sized device was most commonly used (58.8% - (b) (4) | | All Subjects Mean ± SD (N) | |--------------------------------|--------------------------------| | | Median, Min, Max Or #/# (%) | | Parameters | | | Surgical Level: | | | • L2-L3 | (b) (4)(1.0%) | | • L3-L4 | (b) (4) (3.9%) | | • L4-L5 | (b) (4) (66.7%) | | • L5-S1 | (b) (4) (28.4%) | | Operative Time (hours) | 2.6 ± 0.9 (b) (4) | | | 2.6, 1.0, 5.4 | | | 95% CI: 2.5-2.8 | | Estimated Blood Loss (cc) | 137.3 ± 217.4 (b) (4) | | | 75.0, 5.0, 1800.0 | | | 95% CI: 94.6-180.0 | | Length of Hospital Stay (days) | 2.3 ± 1.2 (b) (4) | | | 2.0, 0, 5.0 | | | 95% CI: 2.1-2.6 | | Surgical Approach: | | | • Open Procedure | 9.8% (b) (4) | | • Minimally Invasive Procedure | 90.2% (b) (4) | | SIFS Device Used: | | | • Small (300-2002) | 37.3% (b) (4) | | • Medium (300-2302) | 58.8% (b) (4) | | • Large (300-2702) | 3.9% (b) (4) | | | | | Table 5: Intra-operative and Hospital Data of the Investigational Cohort | | |--|--|--|--------------------------------------------------------------------------|--| # Clinical Outcomes: Pain Assessment: The individual VAS pain scores over time reported for low back, right leg, left leg and iliac crest graft harvest pain are provided in Table 6 below. The average VAS pain scores decreased at 24 months when compared to the baseline (e.g., a mean VAS Low Back Pain score of (4) {13}------------------------------------------------ was reported for all subjects at the 24-month time point as compared to a mean VAS Low Back Pain score of (b) (4) at baseline). | | Mean ± SD (N) (Min, Median, Max) | | | | | | |-----------------------------|-------------------------------------|--------|---------|---------|----------|----------| | | Baseline | 6-Week | 3-Month | 6-Month | 12-Month | 24-Month | | Low Back Pain | | | | | | | | At Follow-Up Exam | (b) (4) | | | | | | | 95% Confidence Interval | | | | | | | | Change from Baseline | | | | | | | | 95% Confidence Interval | | | | | | | | Right Leg Pain | | | | | | | | At Follow-Up Exam | (b) (4) | | | | | | | Confidence Interval | | | | | | | | Change from Baseline | | | | | | | | Confidence Interval | | | | | | | | Left Leg Pain | | | | | | | | At Follow-Up Exam | (b) (4) | | | | | | | 95% Confidence Interval | | | | | | | | Change from Baseline | | | | | | | | 95% Confidence Interval | | | | | | | | Iliac Crest Graft Site Pain | | | | | | | | At Follow-Up Exam | (b) (4) | | | | | | | 95% Confidence Interval | | | | | | | Table 6: Mean VAS Pain Scores of the Investigational Cohort Through 24 Months ## Function Assessment The ODI scores over time are provided in Table 7 below. The average ODI score decreased at each successive time point, with the mean ODI score at 24 months reported as (0) (4) as compared to the mean ODI score at baseline reported as (b) (4) Table 7: Mean ODI Scores of the Investigational Cohort Through 24 Months | ODI Score | Mean ± SD (N) (Min, Median, Max) | | | | | | |----------------------------|-------------------------------------|--------|---------|---------|----------|----------| | | Baseline | 6-Week | 3-Month | 6-Month | 12-Month | 24-Month | | At Follow-Up Exam | (b) (4) | | | | | | | 95% Confidence Interval | | | | | | | | Change from Baseline | | | | | | | | 95% Confidence Interval | | | | | | | {14}------------------------------------------------ # Radiographic Assessment: Fusion was assessed by independent radiologists at the 12-month time point, and again at 24 months for those subjects who had not fused. At 12 months, "My subjects were evaluated for fusion. (D) (4) designation of "fused" at 12 months, and one of those (b)(4)subjects was not imaged due to pregnancy. At the 24-month time point, (b) (4) of those (b) (4)subjects were determined to be fused. The (010) patient that was determined not fused was the subject who was pregnant at the 12-month time point. Overall, at 24 months, the fusion rate for all evaluated subjects is 99.0% (b) (4) when considering the 12- and 24-month fusion assessments, and similarly, 99.0% (b) (4) when considering subjects who were evaluated at 24 months. The fusion status is summarized in Table 8 below. Table 8: Fusion Status of the Investigational Cohort as Assessed by Evidence of Bridging Bone Through 24-Months | Bridging Bone (Fusion) Status Determination | 12-Month Visit | 24-Month Visit | Combined 12/24- Month Status (n=(b) (4)) | |-----------------------------------------------------------|----------------|----------------|------------------------------------------------| | All Subjects 12 & 24 Combined (n=(b) (4)) | | | | | Bridged | 97.9% (b) (4) | 75.0% (b) (4) | 99.0% (b) (4) | | 95% Confidence Interval | 92.7%, 99.7% | 19.4%, 99.4% | 94.5%, 100.0% | | Only Subjects Achieving a 24-Month Evaluation (n=(b) (4)) | | | | | Bridged | 97.9% (b) (4) | 75.0% (b) (4) | 99.0% (b) (4) | Radiographic imaging also assessed for device expulsion, subsidence, radiolucency and adjacent segment degeneration and summarized in Table 9 below.(D) (4) subjects were determined to have subsidence at the 12-month time point. All (b) (4) (4) subjects who had subsidence also had bone bridging at 12 months per the imaging. (b) (4) subjects had radiolucency at the 12-month time point. Of those (b) (4) subject had bone bridging at the 12-month time point and the other subject had bone bridging at the 24-month timepoint. P {15}------------------------------------------------ Table 9: Device Expulsion, Subsidence, Radiolucency and Adjacent Segment Degeneration of the Investigational Cohort Through 24-Months | Parameter | | | % (#/#) | |-------------------------------------------------------------------------------------------------------|---------------|--------------|-----------------------| | | 12-Month | 24-Month | Combined 12-/24-Month | | Expulsion (device moved outside the disc space) | | | | | At Follow-Up Exam | 0.0% (b) (4) | 0.0%(b) (4) | 0.0%(b) (4) | | 95% Confidence Interval | 0.0%, 3.7% | 0.0%, 60.2% | 0.0%, 3.7% | | Subsidence (>5 mm migration of implant from original position) | | | | | At Follow-Up Exam | 3.1% ((b) (4) | 0.0% (b) (4) | 3.0% (b) (4) | | 95% Confidence Interval | 0.6%, 8.8% | 0.0%, 60.2% | 0.6%, 8.6% | | Radiolucency (> 50% of implant/endplate interface shows true lucency (true lucency is black not gray) | | | | | At Follow-Up Exam | 2.1% (b) (4) | 0.0% (b) (4) | 1.0%(b) (4) | | 95% Confidence Interval | 0.3%, 7.3% | 0.0%, 60.2% | 0.0%, 5.5% | | Adjacent Level Degeneration (>5 mm loss of disc height; >3 mm translation on flexion/extension | | | | | At Follow-Up Exam | 0.0%(b) (4) | 0.0% (b) (4) | 0.0% (b) (4) | | 95% Confidence Interval…

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