← Product Code [NKB](/productcode/NKB) · K262067

# iFuse Granite Onyx™ Implant System (K262067)

_SI-BONE, Inc. · NKB · Sep 23, 2026 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262067

## Device Facts

- **Applicant:** SI-BONE, Inc.
- **Product Code:** [NKB](/productcode/NKB.md)
- **Decision Date:** Sep 23, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3070
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

When connected to compatible pedicle screw systems with 5.0-, 5.5-, or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies • spondylolisthesis • trauma (i.e., fracture or dislocation) • spinal stenosis • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • spinal tumor • pseudarthrosis, and/or • failed previous fusion. When connected to compatible pedicle screw systems with 5.0-, 5.5-, or 6.0- mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods. The iFuse Granite Onyx Navigation instruments are intended to be used with the iFuse Granite Onyx Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Granite Onyx Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy. The Onyx iGPS instruments are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Granite Onyx Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

## Device Story

Implant system provides spinal segment immobilization/stabilization; connects to compatible pedicle screw systems using 5.0/5.5/6.0mm titanium or cobalt chrome rods. Includes navigation instruments for use with Medtronic StealthStation or Globus ExcelsiusGPS systems. Surgeon uses navigation to locate anatomical structures via CT, MR, or fluoroscopic images/reconstructions. System aids in precise instrument positioning during open procedures. Benefits include enhanced surgical accuracy and stabilization of spinal segments. Used in clinical settings by surgeons.

## Clinical Evidence

No clinical data. Evidence consists of bench testing including simulated use, static/dynamic flexion-extension, axial/torsional grip, cantilever testing, torque testing, axial pullout, and construct compression bending per ASTM standards. Accuracy/durability testing performed for navigated instruments.

## Technological Characteristics

Implant material: Ti-6Al-4V ELI (ASTM F3001). Compatible with 5.0/5.5/6.0mm titanium/cobalt chrome rods. Navigation instruments interface with Medtronic StealthStation and Globus ExcelsiusGPS systems. Mechanical fixation via pedicle screw system. Testing per ASTM F1798, F2193, F543, F1717.

## Regulatory Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

## Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
 “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

## Predicate Devices

- Invictus Spinal Fixation System ([K214006](/device/K214006.md))
- iFuse Bedrock Granite Implant System ([K233508](/device/K233508.md), [K222774](/device/K222774.md), [K220195](/device/K220195.md))
- A8 INTEGR8 Porous Pedicle Screws ([K242827](/device/K242827.md))
- Navigated CD HORIZON® SOLERA® Taps ([K140454](/device/K140454.md))
- Excelsius GPS™ Instruments ([K171651](/device/K171651.md))

## Reference Devices

- iFuse TORQ TNT Implant System ([K241504](/device/K241504.md))
- iGPS Navigation Instruments ([K251780](/device/K251780.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
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**U.S. FOOD & DRUG**
ADMINISTRATION

September 23, 2026

SI-BONE, Inc.
Jayasri Prabakaran
Director of Regulatory Affairs
471 El Camino Real
Suite 101
Santa Clara, California 95050

Re: K262067

Trade/Device Name: iFuse Granite Onyx™ Implant System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: NKB, OLO
Dated: August 26, 2026
Received: August 26, 2026

Dear Jayasri Prabakaran:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K262067 - Jayasri Prabakaran

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clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K262067 - Jayasri Prabakaran

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Sincerely,

COLIN O'NEILL -S

Colin O'Neill, M.B.E.

Assistant Director

DHT6B: Division of Spinal Devices

OHT6: Office of Orthopedic Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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|  Indications for Use  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262067 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  iFuse Granite Onyx™ Implant System  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  When connected to compatible pedicle screw systems with 5.0-, 5.5-, or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies • spondylolisthesis • trauma (i.e., fracture or dislocation) • spinal stenosis • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • spinal tumor • pseudarthrosis, and/or • failed previous fusion. When connected to compatible pedicle screw systems with 5.0-, 5.5-, or 6.0- mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods. The iFuse Granite Onyx Navigation instruments are intended to be used with the iFuse Granite Onyx Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Granite Onyx Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy. The Onyx iGPS instruments are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Granite Onyx Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.  |   |   |

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|  Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |
| --- | --- | --- |
|  Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ?  |

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K262067

Page 1 of 4

SI-BONE, Inc.

Traditional 510(k) Submission

iFuse Granite Onyx™ Implant System

# 510(k) SUMMARY

# iFuse Granite Onyx™ Implant System

# I. 510(k) SUBMITTER

SI-BONE, Inc.

471 El Camino Real, Suite 101,

Santa Clara, CA 95050

Phone: 408-207-0700

Fax: 408-557-8312

Contact Person: Jayasri Prabakaran, Director, Regulatory Affairs

FDA Establishment

Registration No.: 3007700286

Date Prepared: September 16, 2026

# II. DEVICES

# DEVICE 1:

Trade Name of Device iFuse Granite Onyx™ Implant System

Regulation Name Thoracolumbosacral Pedicle Screw System

Regulation Number 21 CFR 888.3070

Regulatory Class II

Product Code NKB

# DEVICE 2:

Trade Name of Device iFuse Granite Onyx Navigation Instruments intended to be used with the iFuse Granite Onyx Implant System and the Medtronic StealthStation System

Regulation Name Stereotaxic instruments

Regulation Number 21 CFR 882.4560

Regulatory Class II

Product Code OLO

# DEVICE 3:

Trade Name of Device Onyx iGPS instruments compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Granite Onyx Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System)

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K262067

Page 2 of 4

# SI-BONE, Inc.

# Traditional 510(k) Submission

# iFuse Granite Onyx™ Implant System

|  Regulation Name | Stereotaxic instruments  |
| --- | --- |
|  Regulation Number | 21 CFR 882.4560  |
|  Regulatory Class | II  |
|  Product Code | OLO  |

### III. PREDICATE DEVICES

Primary Predicate:

|  Predicate Device | Manufacturer | 510(k)# | Clearance Date  |
| --- | --- | --- | --- |
|  Device 1: Invictus Spinal Fixation System | Alphatec Spine, Inc. | K214006 | 4 April 2022  |

Additional Predicates:

|  Predicate Device | Manufacturer | 510(k)# | Clearance Date  |
| --- | --- | --- | --- |
|  Device 1: iFuse Bedrock Granite Implant System | SI-BONE, Inc. | K233508 K222774 K220195 | 26 January 2024 22 December 2022 26 May 2022  |
|  Device 1: A8 INTEGR8 Porous Pedicle Screws | Allumin8 | K242827 | 20 October 2025  |
|  Device 2: Navigated CD HORIZON® SOLERA® Taps | Medtronic Sofamor Danek, USA Inc. | K140454 | 22 May 2014  |
|  Device 3: Excelsius GPS™ Instruments | Globus Medical, Inc. | K171651 | 16 August 2017  |

Reference devices:

|  Device name | Manufacturer | 510(k)# | Clearance Date  |
| --- | --- | --- | --- |
|  iFuse TORQ TNT Implant System | SI-BONE, Inc. | K241504 | 19 August 2024  |
|  iGPS Navigation Instruments | SI-BONE, Inc. | K251780 | 15 September 2025  |

### IV. PURPOSE

This 510(k) includes:

- A description of the Onyx implant, associated instrumentation, substantial equivalence comparison between the subject device and its predicates, and testing.

### V. DEVICE DESCRIPTION

The iFuse Granite Onyx Implant System consists of an implant and the associated instruments to provide fixation and fusion of spinal segments in the thoracolumbar and sacral spine. The implant is manufactured using Ti-6Al-4V ELI per ASTM F3001. The implant system also includes two different set screws to be used with commercially available pedicle screw systems via Ø 5.0mm, Ø 5.5mm and Ø 6.0mm titanium alloy or cobalt chrome spinal fixation rods.

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K262067

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SI-BONE, Inc.

Traditional 510(k) Submission

iFuse Granite Onyx™ Implant System

# VI. INDICATIONS FOR USE

When connected to compatible pedicle screw systems with 5.0-, 5.5-, or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal stenosis
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- spinal tumor
- pseudarthrosis, and/or
- failed previous fusion.

When connected to compatible pedicle screw systems with 5.0-, 5.5-, or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.

The iFuse Granite Onyx Navigation instruments are intended to be used with the iFuse Granite Onyx Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Granite Onyx Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy.

The Onyx iGPS instruments are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Granite Onyx Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

# VII. SUMMARY OF SUBSTANTIAL EQUIVALENCE

The subject device is substantially equivalent to its predicates in terms of intended use, indications for use, technological characteristics, materials, manufacturing methods, and principles of operation. The differences in the indication for use statement from the previously cleared legally marketed predicate are not critical to the intended use of the subject device. Therefore, based on

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K262067

Page 4 of 4

SI-BONE, Inc.

Traditional 510(k) Submission

iFuse Granite Onyx™ Implant System

the intended use, technological characteristics, and principles of operation, iFuse Granite Onyx Implant System is substantially equivalent to its predicate devices.

### VIII. PERFORMANCE DATA

SI-BONE performed the following performance tests:

- Simulated Use Testing
- Bench Testing
  i. Implant Static and Dynamic Flexion-Extension Testing per ASTM F1798.
  ii. Implant Static Axial Grip Testing per ASTM F1798.
  iii. Implant Static Torsional Grip Testing per ASTM F1798.
  iv. Implant Static Anterior-Posterior Testing per ASTM F1798.
  v. Implant Static and Dynamic Cantilever Testing per modified ASTM F2193.
  vi. Torsion, Insertion, and Removal Torque Testing per ASTM F543.
  vii. Axial Pullout Testing per ASTM F543.
  viii. Construct Static and Dynamic Compression Bending Testing per ASTM F1717.
  ix. Functional Performance Testing for implants and instruments.
  x. Durability and accuracy testing for navigated instruments

Testing was performed on a range of rod diameters and manufacturing methods to demonstrate compatibility with the iFuse Granite Onyx™ Implant System.

The test results demonstrate that the subject device, iFuse Granite Onyx Implant System (including associated instrumentation) is substantially equivalent to the predicate devices.

### IX. CONCLUSION

The iFuse Granite Onyx Implant System (including associated instrumentation) is substantially equivalent to its predicate devices in terms of intended use and indications for use, technological characteristics, materials, manufacturing methods, and principles of operation. Testing has shown substantially equivalent benchtop performance. The differences in the indication for use statement from the previously cleared, legally marketed predicates are not critical to the intended use of the subject device. Test results demonstrate that the subject device is substantially equivalent to the legally marketed devices and do not raise different questions of safety and effectiveness than the predicate devices.

---

**Source:** [https://fda.innolitics.com/device/K262067](https://fda.innolitics.com/device/K262067)

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