(87 days)
The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
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 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.
This document, K191748, is a 510(k) Premarket Notification from Genesys Spine for their Sacroiliac Joint Fusion System. As such, it does not contain details of clinical studies, acceptance criteria, or ground truth establishment typically associated with AI/ML-driven medical devices.
Medical devices cleared through the 510(k) pathway, especially those like bone fixation fasteners, are primarily evaluated based on equivalence to legally marketed predicate devices through non-clinical performance evaluations (mechanical testing), rather than human clinical trials or complex algorithms requiring extensive performance studies with acceptance criteria for sensitivity, specificity, etc.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance: This document does not present such a table. The acceptance criteria for this device are implied by its substantial equivalence to predicate devices, meaning it must meet similar mechanical and material properties.
- Sample size used for the test set and data provenance: Non-clinical mechanical testing does not involve human subjects or "data provenance" in the clinical sense. Test "samples" would refer to the number of devices tested, but specific numbers are not provided, only the standards used (e.g., ASTM F2193-18a).
- Number of experts used to establish ground truth: Not applicable for a mechanical device.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an image-based diagnostic or AI-assisted device.
- Standalone (algorithm only) performance: There is no algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as there's no machine learning model.
- How the ground truth for the training set was established: Not applicable.
What the document does provide in terms of performance evaluation:
The document states that non-clinical testing was performed on "worst-case devices" and "demonstrated substantially equivalent performance to the predicate systems." The mechanical tests performed are listed:
- 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)
The acceptance criteria for these tests would be defined by the specified ASTM standards and the performance of the predicate devices. The "reported device performance" is summarized by the statement that it "demonstrated substantially equivalent performance to the predicate systems," meaning it met or exceeded the performance benchmarks set by the predicates under these test conditions. However, specific numerical results or detailed pass/fail thresholds are not included in this summary.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@.fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{3}------------------------------------------------
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 SouthBuilding Three, Suite 600Austin, 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(unmodified) devices toWhich SubstantialEquivalence is Claimed: | Primary Predicate: Silex Sacroiliac Joint Fusion System(X–Spine Systems, Inc. – K123702)Additional Predicates:Synthes 6.5mm Cannulated Screw (Synthes (USA) –K021932)SI Joint Fusion System (SI-Bone, Inc. – K080398 &K092375)SImmetry Sacroiliac Joint Fusion System (ZygaTechnology, Inc. – K141549)RIALTO SI Fusion System (Medtronic Sofamor Danek –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
{4}------------------------------------------------
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.