Genesys Spine Sacroiliac Joint Fusion System

K191748 · Genesys Spine · OUR · Sep 26, 2019 · Orthopedic

Device Facts

• Record ID: K191748
• Device Name: Genesys Spine Sacroiliac Joint Fusion System
• Applicant: Genesys Spine
• Product Code: OUR · Orthopedic
• Decision Date: Sep 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Device Story

System consists of cannulated, self-tapping titanium alloy (Ti-6Al-4V ELI) screws and optional washers; designed to secure sacroiliac joint and minimize micromotion to enable bony fusion. Screws feature fenestrations for allograft apposition; dual-thread or fully-threaded patterns provide joint compression. Used in surgical setting by orthopedic or spine surgeons; delivery system utilizes guide pins for placement into pre-drilled bone. Implants provided non-sterile for single use. Output is mechanical stabilization of the joint; clinical benefit is fusion across the graft space to treat degenerative sacroiliitis or joint disruptions.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static bending strength, fatigue bending strength, torsional strength/breaking angle, insertion/removal torque, and pullout force per ASTM F2193-18a and ASTM F543-17 standards.

Technological Characteristics

Materials: Ti-6Al-4V ELI titanium alloy. Design: Cannulated, self-tapping screws (up to 13.5mm diameter, 70mm length) with fenestrations. Mechanical: Dual/fully threaded for compression. Standards: ASTM F2193-18a (bending), ASTM F543-17 (torsion/pullout). Sterilization: Non-sterile (user-sterilized). Connectivity: None.

Indications for Use

Indicated for patients requiring sacroiliac joint fusion due to degenerative sacroiliitis or sacroiliac joint disruptions.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Silex Sacroiliac Joint Fusion System (K123702)
• Synthes 6.5mm Cannulated Screw (K021932)
• SI Joint Fusion System (K080398 & K092375)
• SImmetry Sacroiliac Joint Fusion System (K141549)
• RIALTO SI Fusion System (K161210)

Submission Summary (Full Text)

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September 26, 2019

Genesys Spine Mr. William W. Sowers VP of Engineering 1250 Capital of Texas Highway South, Building Three, Suite 600 Austin, Texas 78746

Re: K191748

Trade/Device Name: Genesys Spine Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: June 28, 2019 Received: July 1, 2019

Dear Mr. Sowers:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Ronald P. Jean, Ph.D. Director (Acting) 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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#### 3. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

#### K191748

Device Name Genesys Spine Sacroiliac Joint Fusion System

Indications for Use (Describe)

The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is written in gray, except for the "G" which is written in brown and has an arrow-like design. Below "Genesys" is the word "spine" in brown with a registered trademark symbol.

#### 4. 510(K) SUMMARY

| Submitter's Name: | Genesys Spine |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 1250 Capital of Texas Highway South<br>Building Three, Suite 600<br>Austin, Texas 78746 |
| Contact Name: | William W. Sowers |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 512-381-7076 |
| Date Summary was Prepared: | June 28, 2019 |
| Trade or Proprietary Name: | Genesys Spine Sacroiliac Joint Fusion System |
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification: | Class II |
| Regulation Number: | 21 CFR §888.3040 |
| Product Codes: | OUR |
| Classification Panel: | Orthopedic Devices (OHT6), Spine Devices (DHT6B) |
| Legally Marketed<br>(unmodified) devices to<br>Which Substantial<br>Equivalence is Claimed: | Primary Predicate: Silex Sacroiliac Joint Fusion System<br>(X–Spine Systems, Inc. – K123702)<br><br>Additional Predicates:<br>Synthes 6.5mm Cannulated Screw (Synthes (USA) –<br>K021932)<br>SI Joint Fusion System (SI-Bone, Inc. – K080398 &<br>K092375)<br>SImmetry Sacroiliac Joint Fusion System (Zyga<br>Technology, Inc. – K141549)<br>RIALTO SI Fusion System (Medtronic Sofamor Danek –<br>K161210) |

# DEVICE DESCRIPTION:

Genesys Spine's Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micromotion in order to enable bony fusion. All screws and anchors are cannulated and self-tapping; they are offered with different diameters (up to 13.5mm), lengths (up to 70mm), and styles to accommodate variations in patient anatomy and surgeon preference.

Fusion across the graft space can be aided by the addition of bone graft material to the lumen of each screw; fenestration in each screw allow for direct allograft apposition across the sacroiliac joint. Dual thread screws and fully threaded screws provide joint compression by utilizing a compressive thread

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pattern. Optional Washers are included to aid in conforming to patient anatomy and to help distribute the load onto a larger area. All implants are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI).

The delivery system uses guide pins for accurate surgical placement into pre-drilled bone. All implants will be provided non-sterile and are intended for single use only.

### INDICATIONS FOR USE

The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

### TECHNOLOGICAL COMPARISON TO PREDICATES

The Genesys Spine Sacroiliac Joint Fusion System is substantially equivalent to the predicate systems in terms of:

- Indications for Use
- Physical Characteristics ●
- Mechanical Performance ●
- Principals of Operation ●
- Surgical Approach ●
- . Materials
- Sterility ●

As a result, the subject device does not introduce any new concerns of safety or effectiveness.

# NON-CLINICAL PERFORMANCE EVALUATION

Nonclinical testing was performed on worst-case devices for the Genesys Spine Sacroiliac Joint Fusion System and demonstrated substantially equivalent performance to the predicate systems. The following mechanical tests were performed:

- Static Bending Strength (ASTM F2193-18a)
- Fatigue Bending Strength (ASTM F2193-18a) ●
- Torsional strength/breaking angle (ASTM F543-17)
- Insertion/removal torque (ASTM F543-17) ●
- . Pullout force (ASTM F543-17)

# CONCLUSION

There are no significant differences between the Genesys Spine Sacroiliac Joint Fusion System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent in design, material, features, function, and intended use.