Predicate Devices

OQB

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics of the implant and clinical outcomes, with no mention of AI or ML.

Therapeutic

Yes

The device is an intervertebral body fusion device indicated as an adjunct to fusion for treating degenerative disc disease, which clearly indicates a therapeutic purpose.

Diagnostic

No

This device is an intervertebral body fusion device (an implant) used as an adjunct to fusion for the treatment of degenerative disc disease. It is a therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is comprised of a PET mesh bag, which is a physical hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Description: The Spineology Interbody Fusion System (SIFS) is a physical implant (a PET mesh bag) designed to be placed inside the body during surgery to aid in spinal fusion.
Intended Use: The intended use is to provide structural support and contain bone graft within the intervertebral disc space to promote fusion. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic assays, which are hallmarks of IVD devices.

The SIFS is a surgical implant used in a therapeutic procedure, not a diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

OQB

Device 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).

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Lumbar spine from L2 to S1

Indicated Patient Age Range

Skeletally mature patients. Minimum age of twenty-one (21) years but not greater than eighty (80) years.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

SUMMARY OF NONCLINICAL/BENCH STUDIES

Biocompatibility/Materials: The Spineology Interbody Fusion System is manufactured from Polyethylene Terephthalate (PET) for the implant (direct patient contact, permanent duration) and Stainless Steel for the instruments (direct patient contact, limited duration). Biocompatibility evaluation was completed according to FDA Guidance, Use of International Standard ISO 10993-1.

Shelf Life/Sterility:

Gamma Sterilization: Implant and certain instruments are sterile via gamma radiation. Sterilization was validated using the VDmax method as per ISO 11137 to ensure a minimum Sterility Assurance Level (SAL) of 10. Sterilized samples real-time aged to 5 years were used to determine shelf life. Distribution testing (ASTM D4169), package integrity testing (bubble leak test, ASTM F2096), and seal strength testing (ASTM F88/F88M) validated a 5-year sterile shelf-life. Non-clinical performance testing confirmed a 5-year performance shelf life.
Ethylene Oxide Sterilization: Certain instruments are sterile via ethylene oxide. Validated per ISO 11135 for a minimum SAL of 10-6. Similar shelf-life testing procedures confirm a 5-year shelf-life.
Reprocessing: Certain instruments are provided non-sterile and require cleaning and sterilization by the end-user. Validated reprocessing instructions are provided. Steam sterilization method validated per ISO 17665 and AAMI ST79 for a minimum SAL of 10. Validated parameters for pre-vacuum steam autoclave are 4 minutes at 270°F (132°C) and a dry time of 30 minutes at 270°F (132°C).

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.

Performance Testing - Bench:

Burst Test: Evaluated mechanical properties of the bone graft containment device under compressive load. Method: PET sheets placed between ring clamps, load applied until failure. Performance Criteria: Based on Sponsor historical batch/lot records. Results: Included bursting strength of each specimen and average bursting strength.
Tensile and Elongation Test: Evaluated mechanical properties of the mesh material under tensile load. Method: Adapted from ASTM D3787 and ASTM D5034. PET tubes mounted in clamps, force applied until failure. Performance Criteria: Based on Sponsor historical batch/lot records. Results: Included tensile strength and elongation of each specimen and average, along with standard deviation.
Static Axial Compression: Evaluated mechanical properties of the bone graft containment device when filled with bone graft under static axial compression loading. Method: SIFS implant filled with representative bone graft tested under static compression until failure or approximately (b) (4) N was reached, in accordance with ASTM F2077. Pre- and post-test dimensions and mass were taken. Performance Criteria: No pre-determined. Results: Device deformed; pre- and post-test dimensions/mass provided. Representative images and force-displacement graphs provided; linear equations for stiffness included.
Dynamic Axial Compression: Evaluated mechanical properties of the bone graft containment device when filled with bone graft under dynamic axial compression loading. Method: SIFS implant filled with representative bone graft tested under dynamic compression to (b) million cycles at Hz, in accordance with ASTM F2077. Pre- and post-test dimensions and mass were taken. Performance Criteria: No pre-determined. Results: Device deformed; pre- and post-test dimensions/mass provided. Representative images and cycle-displacement table provided.
Static Compression Shear: Evaluated mechanical properties of the bone graft containment device when filled with bone graft under static compression-shear loading. Method: SIFS implant filled with representative bone graft tested under static compression-shear (b)(4)(o) until failure or approximately (b) (4) N was reached, in accordance with ASTM F2077. Pre- and post-test dimensions and mass were taken. Performance Criteria: No pre-determined. Results: Device deformed; pre- and post-test dimensions/mass provided. Representative images and force-displacement graphs provided; linear equations for stiffness included.
Dynamic Compression Shear: Evaluated mechanical properties of the bone graft containment device when filled with bone graft under dynamic compression-shear loading. Method: SIFS implant filled with representative bone graft tested under dynamic compression to (b) million cycles at (b) Hz, in accordance with ASTM F2077. Pre- and post-test dimensions and mass were taken. Performance Criteria: No pre-determined. Results: Device deformed; pre- and post-test dimensions/mass provided. Representative images provided.
Subsidence: Evaluated mechanical properties of the bone graft containment device when filled with bone graft; evaluated implant resistance to subsidence. Method: SIFS implant filled with representative bone graft tested per ASTM F2267. Pre- and post-test dimensions and mass were taken. Performance Criteria: No pre-determined. Results: Device deformed; pre- and post-test dimensions/mass provided. Representative images provided. Stiffness and yield reported.
Expulsion: Evaluated mechanical properties of the bone graft containment device when filled with bone graft; evaluated migration potential. Method: SIFS implant filled with representative bone graft placed in polyurethane foam blocks with a compressive pre-load of (b) (4) N. Load applied until specimen displaced. Performance Criteria: No pre-determined. Results: Included force required to displace the device along with representative pre- and post-test images.
Wear Particulate Analysis: Evaluated the wear debris of the bone graft containment device when filled with bone graft. Method: Wear testing protocol for collection and analyses conducted based on ISO 17853, ASTM F1877, and ASTM F2025. Performance Criteria: No pre-determined. Results: Particulates size and morphological characteristics, as well as associated elemental constituents, were reported.
Simulated Fill Testing: Evaluated the consistency and mechanical features of the bone graft containment device when filled with bone graft by different personnel. Method: Personnel instructed to fill SIFS implant with representative bone graft per protocol. Filled specimens evaluated under Static Axial compression to evaluate mechanical properties. Pre- and post-test dimensions and mass were taken. Performance Criteria: The device is filled consistently and repeatedly across multiple users. Results: Mechanical properties of this group compared to experienced group. Specimens deformed; pre- and post-test dimensions/mass provided. Representative images and force-displacement graphs provided; linear equations for stiffness included.

SUMMARY OF CLINICAL INFORMATION

Study Objective: To demonstrate the safety and effectiveness of the SIFS implant in instrumented lumbar intervertebral body fusion procedures.

Study Design: Prospective, single arm, multi-center study (G140140) by Spineology, based on a previously conducted prospective, randomized, multi-center study (G030106) for the same device.

Sample Size: (b) (4) subjects enrolled and treated across (b) (4) clinical sites.
Inclusion Criteria: Minimum age 21 (max 80) years, skeletally mature, confirmed diagnosis of single-level lumbar DDD (L2-S1) requiring fusion, pre-operative low back pain score ≥ 40mm VAS (100mm scale) correlating with involved level, pre-operative ODI score ≥ 40, at least 6 months conservative treatment without sufficient relief, willing and able to comply with follow-up.
Exclusion Criteria: Previous implant surgery at index level, greater than Grade I spondylolisthesis, symptomatic non-index level lumbar DDD, active systemic infection or local infection, active or suspected malignancy, BMI ≥ 40, significant metabolic bone disease (e.g., osteoporosis T-score

Regulation Number and Section

§ 888.3085 Intervertebral body graft containment device.

(a)
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.(b)
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.

Summary

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 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 | |

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	(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)

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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 | | | | | | |

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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

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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	0.0%, 3.7%	0.0%, 60.2%	0.0%, 3.7%

Additionally, radiographic assessments at the index level for angulation and translation, disc height, and sagittal alignment is summarized in Table 10 below. The mean angulation at 12 months is 1.6 degrees (n=000) of motion and 1.4 degrees at 24 months (n=10)(4) The mean translation at 12 months is 0.7 millimeters (n=000) and 0.9 millimeters at 24 months (n=0)(4)

Table 10: Mean Quantitative Assessment (angulation) for Motion at Index level of the Investigational Cohort Through 24 Months

Image /page/15/Figure/4 description: The image is a table with four columns. The first row contains the column headers: "Parameter", "6-Month", "12-Month", and "24-Month". The second row contains the text "(b) (4)" in the first column, and the remaining columns are empty. The table appears to be set up to display parameters and their values at different time intervals.

The change of the mean disc height over time is summarized in Table 11 below. The baseline measurement post-op was used to compare the disc height to each time point. Immediately post-operatively, the mean disc height increased from 6.5 mm (n=16) (4) at baseline to 9.6 mm (n=101(4) However, this gain in disc height gradually decreased over time, with a mean disc height of 7.0 mm (n=(b)(a) at 24 months.

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Table 11: Mean Disc Height at Index Level of the Investigational Cohort Through 24 Months

Image /page/16/Figure/1 description: The image shows a table with the columns labeled Parameter, Pre-op, Baseline Post-op, 6-Month, 12-Month, and 24-Month. The first row contains the column headers, and the second row contains the text '(b) (4)'. The table appears to be designed to track parameters at different time points before and after an operation.

The change of the mean sagittal alignment at the index segment over time is summarized in Table 12 below. Immediately post-operatively, the mean sagittal alignment (lordosis) increased from 14.9 degrees at baseline (b) (4) to 15.8 degrees (n=10)(4) However, this gain in sagittal alignment gradually decreased over time, with a mean sagittal alignment of 12.7 degrees (n=(b)(4) at 24 months.

Table 12: Mean Sagittal Alignment-Index Segment of the Investigational Cohort Through 24 Months

| Parameter | Pre-op | Baseline
Post-op | 6-Month | 12-Month | 24-Month |
|-----------|--------|---------------------|---------|----------|----------|
| (b) (4) | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |

Safety Assessment

A Clinical Events Committee (CEC) was utilized for the study to mitigate reporting bias of safety-related events. Each event was evaluated for applicability (event versus observation), relatedness to the study (study-related event versus non study-related event), and additional classifications of seriousness (serious adverse events, unanticipated adverse device effects, neither) and severity (mild, moderate, severe).

One hundred and twenty-five (125) events were reported in this study of which 6 were nonevents. The events are classified in Table 13 below:

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Characteristic	# of events	# of subjects	Rate
Includes all adverse events (excludes the 6 non-events/observations)	119	69	67.6%
All Adverse Events	48	32	31.4%
All Study-Related Adverse Events	71	54	52.9%
Severe Study-Related Adverse Events (SAE)	15	13	12.7%
All procedure related adverse events	41	35	34.3%
Procedure - General Surgery	40	34	33.3%
Procedure - Hardware-Related	1	1	1.0%
Procedure - Investigation Device-Related	0	0	0.0%
Hardware-Related Adverse Events	15	13	12.7%
Investigation Device-Related Adverse Events	2	2	2.0%
Serious Procedure-Related Adverse Events	10	8	7.8%
General Surgery	10	8	7.8%
Hardware	0	0	0.0%
Device	0	0	0.0%
Serious Procedure-Related Adverse Events	10	8	7.8
Serious Hardware-Related Adverse Events	0	0	0.0%
Serious Investigation Device-Related Adverse Events	0	0	0.0%

Table 13: Adverse Event Classification of the Investigational Cohort (All Reported During Study)

Some adverse events resulted in subsequent surgical interventions. Subsequent surgical interventions (SSIs) were prospectively classified as revisions, removals, reoperations, supplemental fixations, or other qualified events per FDA's Guidance, Clinical Data Presentations for Orthopedic Device Applications (2004). Overall, there were 8 SSIs in 7 subjects, with 2 device removals, 4 reoperations, 2 surgeries which added supplemental fixation, 3 events categorized as other spinal surgeries, and no device revisions.

| Additional Surgeries | # of
Surgeries | # of
Subjects | Percent of
Subjects (%) |
|----------------------------|-------------------|------------------|----------------------------|
| Index Site Surgery | 8 | 7 | 6.9% |
| Device Revision | 0 | 0 | 0.0% |
| Device Removal | 2 | 2 | 2.0% |
| Reoperation | 4 | 4 | 3.9% |
| Supplemental Fixation | 2 | 2 | 2.0% |
| Other Spinal Surgeries | 3 | 3 | 2.9% |
| Other Non-spinal Surgeries | 10 | 10 | 9.8% |

Table 14: SSI Summary Table for the Investigational Cohort (All Reported During Study)

Neurological assessment was performed at baseline, prior-to-discharge from the hospital, and at each study evaluation thereafter through 24 months. At each timepoint, subjects were evaluated to ascertain if their neurological status (reflexes, sensory, and strength) was improved, maintained, or worsened when compared to pre-op. Most subjects were reported to have improved or maintained their neurological status, with 5.3% (5/95), 2.1% (2/96) and 1.0% (1/96) of subjects reported to have worsened in their reflex, sensory and strength neurological

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assessments, respectively. A summary for each neurological status (reflexes, sensory, and strength) is provided in Table 15 below:

Table 15: Neurological (reflexes, sensory, strength) Status of the Investigational Cohort
Through 24 Months

| | Pre-
surgery | Surgery | 6
Weeks | 3
Months | 6
Months | 12
Months | 24
Months |
|--------------------------------------------|---------------------------------------------|------------------|------------------|------------------|------------------|------------------|------------------|
| Neurological deficiency - Reflexes | 44.6%
(b) (4) | 31.4%
(b) (4) | 28.3%
(b) (4) | 31.0%
(b) (4) | 27.1%
(b) (4) | 28.3%
(b) (4) | 24.0%
(b) (4) |
| | Changes in REFLEXES compared to pre-surgery | | | | | | |
| Improved | | 16.8%
(b) (4) | 21.4%
(b) (4) | 17.2%
(b) (4) | 24.2%
(b) (4) | 22.4%
(b) (4) | 25.3%
(b) (4) |
| No Change | | 79.2%
(b) (4) | 73.5%
(b) (4) | 78.8%
(b) (4) | 70.5%
(b) (4) | 70.4%
(b) (4) | 69.5%
(b) (4) |
| Worsened | | 4.0%
(b) (4) | 5.1%
(b) (4) | 4.0%
(b) (4) | 5.3%
(b) (4) | 7.1%
(b) (4) | 5.3%
(b) (4) |
| | Pre-
surgery | Surgery | 6 Weeks | 3
Months | 6
Months | 12
Months | 24
Months |
| Neurological deficiency - Sensory | 37.3% | 17.6% | 23.2% | 19.0% | 24.0% | 18.2% | 13.5% |
| Changes in SENSORY compared to pre-surgery | | | | | | | |
| Improved | | 22.5% | 22.2% | 22.0% | 18.8% | 23.2% | 25.0% |
| No Change | | 74.5% | 69.7% | 74.0% | 77.1% | 72.7% | 72.9% |
| Worsened | | 2.9% | 8.1% | 4.0% | 4.2% | 4.0% | 2.1% |

| | Pre-
surgery | Surgery | 6
Weeks | 3
Months | 6
Months | 12
Months | 24
Months |
|---------------------------------------------|-----------------|------------------|------------------|------------------|------------------|------------------|------------------|
| Neurological deficiency - Strength | 5.9%
(b) (4) | 3.9%
(b) (4) | 3.0%
(b) (4) | 3.0%
(b) (4) | 3.1%
(b) (4) | 2.0%
(b) (4) | 1.0%
(b) (4) |
| Changes in STRENGTH compared to pre-surgery | | | | | | | |
| Improved | | 2.9%
(b) (4) | 4.0%
(b) (4) | 4.0%
(b) (4) | 4.2%
(b) (4) | 5.1%
(b) (4) | 6.3%
(b) (4) |
| No Change | | 96.1%
(b) (4) | 93.9%
(b) (4) | 95.0%
(b) (4) | 94.8%
(b) (4) | 93.9%
(b) (4) | 92.7%
(b) (4) |
| Worsened | | 1.0%
(b) (4) | 2.0%
(b) (4) | 1.0%
(b) (4) | 1.0%
(b) (4) | 1.0%
(b) (4) | 1.0%
(b) (4) |

Overall Conclusion:

As stated earlier, this prospective, single arm, multi-center study was designed to meet a predetermined performance goal at 24 months which was based on a previously conducted prospective, randomized, multi-center study on the same device. The performance goal was based on four (4) parameters: pain (evaluated by VAS), function (evaluated by ODI, fusion

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(evaluated by imaging), and safety (evaluated by adverse events). These identified parameters are also in-line with the FDA Guidance Document, Preparation and Review of Investigational Device Exemption Avolications (IDEs) for Total Artificial Discs. (D) (4) of the subjects (85.4%) had at least a 20 mm improvement in VAS pain score. (b) (4) of the (b) (4) subjects (81.3%) had at least a 15-point improvement of the (b) (4) in ODI score. (b) (4) subjects (99.0%) achieved a fusion. (b) (4) = of the (b) (4) subjects (92.9%) for freedom from device-related Serious Adverse Events and secondary surgical interventions at the index level. The results are summarized in the table below:

Table 16: Overall

Parameter	Results- % (#/#)
At least 20 mm improvement in VAS	85.4% (82/96)
At least 15-point improvement in ODI	81.3% (78/96)
Fusion	99.0% (96/97)
Freedom from investigational device-related
serious adverse events at the index level and
free of surgical intervention at index level	92.9% (91/98)

The results provided from the study have comparable clinical outcomes as compared to previously published literature related to lumbar fusion (Brantigan,J1; Fritzell P2, Ghogawala2) for lumbar interverbal body fusion devices. The valid scientific evidence presented in the preceding sections demonstrates that the subject device is demonstrated to have a reasonable assurance of safety and effectiveness, and the benefits of using the subject device for its intended use/indications for use outweigh the risks to health.

References:

Brantigan JW, Steffee AD, Lewis ML, Quinn LM, Persenaire JM. Lumbar interbody fusion using the Brantigan IF cage for posterior lumbar interbody fusion and the variable pedicle screw placement system: two-year results from a Food and Drug Administration investigational device exemption clinical trial. Spine, 2000, 25(11):1437-1446.

Pediatric Extrapolation:

In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.

LABELING

The labeling consists of the following: device description, indications for use, instructions for use including surgical steps and device removal, principles of device operation, identification of device materials, contraindications, warnings, precautions, MR compatibility, and a list of potential adverse effects. Furthermore, the sterile packaging includes a shelf life for the device, and the labeling includes reprocessing instructions for the reusable instruments. The labeling meets the requirements of 21 CFR 801.109 for prescription devices.

Fritzell P, Hägg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine, 2001, 26(23):2521-2534.
Ghogawala Z, Dziura J, Butler WE, et al. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med, 2016, 374(15):1424-1434.

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RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of and the measures necessary to mitigate these risks.

Identified Risks to Health	Mitigation Measures
Adverse tissue reaction	Design characteristics
Biocompatibility evaluation
Sterilization/reprocessing validation
Labeling
Infection	Sterilization/reprocessing validation
Labeling
Loosening/migration due to device failure or
failure at the bone/implant interface	Design characteristics
Clinical performance testing
Non-clinical performance testing
Biocompatibility evaluation
Labeling
Tissue injury	Labeling
Pseudarthrosis due to device failure or failure
at the bone-implant interface	Clinical performance testing
Non-clinical performance testing
Biocompatibility evaluation
Labeling
Adverse clinical sequelae	Clinical performance testing
Labeling
Use error/Improper device use	Labeling

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the intervertebral body graft containment device is subject to the following special controls:

(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:

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(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 non-sterile to the end user; and
(v) Detailed instructions of each surgical step, including device removal.

BENEFIT-RISK DETERMINATION

The sponsor has collected adequate data to assess the safety profile of the subject device and has identified that there are benefits. The study has demonstrated reduction of pain and functional improvement as discussed in the clinical section. The most common study-related adverse events were pain (15.7%- 16/102), symptomatic adjacent level DDD (5.9% -6/102), and lumbar muscle spasm/strain (4.9%- 5/102). The list of potential adverse effects is provided in the labeling. In conclusion, the benefits of using the subject device for its intended use/indications for use outweigh the risks to health.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

Benefit/Risk Conclusion

In conclusion, given the available information above, for the following indication statement:

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 compatible allograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The probable benefits outweigh the probable risks for the Spineology Interbody Fusion System. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The De Novo for the Spineology Fusion System is granted and the device is classified as follows:

Product Code: OQB Device Type: Intervertebral Body Graft Containment Device Regulation Number: 21 CFR 888.3085 Class: II