(207 days)
The OrthoFundamentals TRELLIST™ SI Joint Fusion and Stabilization Implant System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including:
Sacroiliac joint disruptions
Degenerative sacroiliitis
To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The TRELLIS™ SI Joint Fusion System is a multiple component system consisting of sterile single use accessory instruments and sterile individually packaged screws of various lengths and diameters. The screws are designed to compress and stabilize the sacroiliac joint during the fusion process. They are self-tapping and are designed with a porous mid-shaft region to allow bone to grow onto and into its surface. The cannulated screws have axial fenestrations that allow bone through growth and packing with autograft bone or allograft material. The screws are designed to promote bony fusion onto and into the implant through the macro-surface topography which is generated through EBM additive manufacturing. The fenestration geometry harvests autograft during insertion which helps create an environment for bony in-growth and on-growth.
The provided text describes the regulatory clearance (510(k) submission) for the TRELLIS™ SI Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than proving device performance through clinical studies with acceptance criteria in the context of diagnostic accuracy or clinical outcomes.
Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable to this document as it's a submission for a medical device (implantable screw system), not a diagnostic algorithm or AI software.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense of a diagnostic or AI study (e.g., sensitivity, specificity thresholds). Instead, it lists various bench tests performed to demonstrate substantial equivalence to predicate devices. The "performance" is reported as "Substantially Equivalent" or "Pass" compared to the predicate or established standards.
| Test | Finding |
|---|---|
| Screw Pull-Out Force Testing | Substantially Equivalent |
| Insertion and Removal Torque Testing | Pass |
| Torsion Properties Testing | Substantially Equivalent |
| Static and Fatigue Bend Testing | Substantially Equivalent |
| Package Seal Strength Verification | Pass |
| Surface Characterization | Substantially Equivalent |
| Biocompatibility Justification | Pass |
| Component Testing Plan and Justification for Test Coupon Location | Pass |
| Porous Surface Lattice Abrasion Resistance | Pass |
| Porous Surface Lattice Stereological Evaluation | Pass |
| Porous Surface Lattice Mechanical Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as there was no clinical or animal testing reported in this 510(k) summary. The "test set" refers to the mechanical/physical properties of the device components themselves, not patient data. The provenance of the data is from laboratory bench tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. Ground truth, in the context of diagnostic or AI studies, refers to definitive diagnoses or classifications. For a medical device like this, "ground truth" would be the engineering specifications and performance values established through validated testing methods. The "experts" involved are likely engineers performing and evaluating the bench tests against established standards.
4. Adjudication Method
This information is not applicable. Adjudication is relevant for reviewing conflicting expert opinions in diagnostic studies, which is not the nature of this submission. The "adjudication" for bench tests would be the interpretation of test results against relevant ASTM standards or internal specifications by qualified engineers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. No MRMC study was performed as this is a physical medical device, not a diagnostic AI or imaging interpretation system designed to assist human readers.
6. Standalone (Algorithm Only) Performance
This information is not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the bench tests effectively consisted of:
- Engineering specifications and standards: Performance requirements derived from relevant ASTM standards (e.g., for mechanical strength, biocompatibility).
- Predicate device performance: The performance characteristics of the legally marketed predicate devices against which the TRELLISTM system was compared to demonstrate "substantial equivalence."
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device submission. This is a physical device, not an AI model requiring a training dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device submission.
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April 11, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
OrthoFundamentals, LLC Howard Schrayer Regulatory Consultant 8 Lookout Hilton Head Island, Massachusetts 29928
Re: K212962
Trade/Device Name: TRELLISTM SI 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: March 8, 2022 Received: March 9, 2022
Dear Howard Schrayer:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 medical devices and radiation-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,
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: 06/30/2023See PRA Statement below. |
| 510(k) Number (if known) | K212962 |
| Device Name | TRELLIST™ SI Joint Fusion System |
| Indications for Use (Describe) | |
| The OrthoFundamentals TRELLIST™ SI Joint Fusion and Stabilization Implant System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including: | |
| Sacroiliac joint disruptions | |
| Degenerative sacroiliitis | |
| To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and | |
| Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. | |
| 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork 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 FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY
(PER 21 CFR 807.92)
General Company Information
| Name: | OrthoFundamentals, LLC |
|---|---|
| Contact: | Howard Schrayer |
| Address: | 173 Governors AvenueMedford, MA 02155 |
| Telephone: | 609.273.7350 |
| Date Prepared: | April 11, 2022 |
| General Device Information | |
| Product Name: | TRELLIS™ SI Joint Fusion System |
| Classification: | Smooth Or Threaded Metallic Bone Fixation FastenerProduct code: OUR – Class II21 CFR 888.3040 |
| Predicate Device | |
| Primary Predicate | |
| OrthoFix | Firebird SI510(k) K203138 |
| Additional Predicates | |
| Synthes | 6.5mm Cannulated Screw510(k) K029132 |
| Keystone Dental | Genesis Implant System510(k) K101545 |
| SI Bone | iFuse Implant System510(k) K193524 |
| Globus | SI-LOK Sacroiliac Joint Fixation System510(k) K183119 |
| Zyga Technology, Inc SImmetry Sacroiliac Joint Fusion System510(k) K141549 |
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Device Description
The TRELLIS™ SI Joint Fusion System is a multiple component system consisting of sterile single use accessory instruments and sterile individually packaged screws of various lengths and diameters. The screws are designed to compress and stabilize the sacroiliac joint during the fusion process. They are self-tapping and are designed with a porous mid-shaft region to allow bone to grow onto and into its surface. The cannulated screws have axial fenestrations that allow bone through growth and packing with autograft bone or allograft material. The screws are designed to promote bony fusion onto and into the implant through the macro-surface topography which is generated through EBM additive manufacturing. The fenestration geometry harvests autograft during insertion which helps create an environment for bony in-growth and on-growth.
Indications for Use
The OrthoFundamentals TRELLIS™ SI Joint Fusion System is indicated for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including:
- · sacroiliac joint disruptions
- · degenerative sacroiliitis
- · to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
- · acute, non-acute, and non-traumatic fractures involving the sacroiliac ioint.
Substantial Equivalence Bench Testing
A series of laboratory studies (bench tests) have been conducted to verify the suitability of the TRELLIS™ SI Joint Fusion System for its intended use, establish Substantial Equivalence with the predicate devices and confirm the reproducibility of packaging.
These tests include:
| Test | Finding |
|---|---|
| Screw Pull-Out Force Testing | Substantially Equivalent |
| Insertion and Removal Torque Testing | Pass |
| Torsion Properties Testing | Substantially Equivalent |
| Static and Fatigue Bend Testing | Substantially Equivalent |
| Package Seal Strength Verification | Pass |
| Surface Characterization | Substantially Equivalent |
| Biocompatibility Justification | Pass |
| Component Testing Plan and Justification for Test CouponLocation | Pass |
| Porous Surface Lattice Abrasion Resistance | Pass |
| Porous Surface Lattice Stereological Evaluation | Pass |
| Porous Surface Lattice Mechanical Testing | Pass |
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Similarities and Differences
OrthoFundamentals TRELLIS™ SI Joint Fusion System 510(k) TBD
Indicated for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion
Product Code: Class II 21 CFR 888.3040
Prescription use in OR setting
Cannulated screw-based implant for implantation over a k-wire
Implant uses threads for primary means of fixation
Implant is available in a varietv of lengths and diameters
Device is fabricated from Titanium-6Aluminum-4Vanadium ELI per ASTM F3001-14
Device is additively manufactured
Device is available in 9mm and 11mm diameters
Device is available in lengths 30mm to 70mm
Device is provided with single-use, sterile accessory delivery tools
Synthes 6.5mm Cannulated Screw 510(k) K021932
Similarities
Indicated for SI joint disruptions
Product Code: Class II 21 CFR 888.3040
Prescription use in OR setting
Cannulated screw-based implant for implantation over a k-wire
Implant uses threads for primary means of fixation
Implant is available in a variety of lengths
Device is fabricated from stainless steel or titanium allov
Device is traditionally machined
Device is available in 6.5mm diameters
Device is available in lengths 30mm to 200mm
Device provided with nonsterile accessories
OrthoFix Firebird Sl 510(k) K203138
Indicated for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion
Product Code: Class II 21 CFR 888.3040
Prescription use in OR setting
Cannulated screw-based implant for implantation over a k-wire
Implant uses threads for primary means of fixation
Implant is available in a varietv of lengths and diameters
Device is fabricated from Titanium-6Aluminum-4Vanadium ELI per ASTM F3001-14
Device is additively manufactured
Device is available in 9mm, 11mm and 12mm diameters
Device is available in lengths 25mm to 70mm
Device provided with nonsterile accessories that may be resterilized (9mm screw is also non-sterile)
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| Device is provided sterile bygamma radiation and storedat room temperature forsingle patient use | Device is provided non-sterile | Device is provided in sterileand non-sterileconfigurations |
|---|---|---|
| Initial shelf-life of 1 yearbased on packagingvalidations | No shelf-life provided | No shelf-life provided |
Performance Data
No animal or clinical testing has been conducted.
This submission supports the position that the OrthoFundamentals TRELLIS™ SI Joint Fusion System is substantially equivalent to the Primary and Additional predicates listed above. A number of other predicate devices list the same range of clinical uses. See above for specific non-clinical testing conducted to demonstrate substantial equivalence of the TRELLIS™ SI Joint Fusion System.
Conclusions
OrthoFundamentals, LLC believes that the information provided establishes that similar legally marketed devices have been used for the same clinical application as the TRELLIS™ SI Joint Fusion System. The device is substantially equivalent to the referenced predicates.
§ 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.