(207 days)
Not Found
No
The summary describes a mechanical implant system and its associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are bench tests of mechanical properties.
Yes.
The device is intended for fixation and fusion of the sacroiliac joint, addressing conditions such as disruptions and degenerative sacroiliitis, which directly treat a medical condition.
No
The device is described as an implant system for fixation and fusion of the sacroiliac joint, rather than for diagnosing conditions.
No
The device description explicitly details physical components (screws, accessory instruments) and bench testing related to the mechanical properties of these hardware components. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for fixation and fusion of the sacroiliac joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a system of screws designed to be implanted into the sacroiliac joint. This is a physical implant, not a reagent, instrument, or system intended for use in vitro (outside the body) to examine specimens derived from the human body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
In summary, the OrthoFundamentals TRELLIST™ SI Joint Fusion and Stabilization Implant System is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OrthoFundamentals TRELLIS™ 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.
Product codes
OUR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use in OR setting
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)
Substantial Equivalence Bench Testing:
- 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
No animal or clinical testing has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K203138, K029132, K101545, K193524, K183119, K141549
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: 06/30/2023 |
| See 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 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 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 Avenue |
| Medford, 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 Fastener |
| Product code: OUR – Class II | |
| 21 CFR 888.3040 | |
| Predicate Device | |
| Primary Predicate | |
| OrthoFix | Firebird SI |
| 510(k) K203138 | |
| Additional Predicates | |
| Synthes | 6.5mm Cannulated Screw |
| 510(k) K029132 | |
| Keystone Dental | Genesis Implant System |
| 510(k) K101545 | |
| SI Bone | iFuse Implant System |
| 510(k) K193524 | |
| Globus | SI-LOK Sacroiliac Joint Fixation System |
| 510(k) K183119 | |
| Zyga Technology, Inc SImmetry Sacroiliac Joint Fusion System | |
| 510(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 Coupon | |
| Location | 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 by
gamma radiation and stored
at room temperature for
single patient use | Device is provided non-
sterile | Device is provided in sterile
and non-sterile
configurations |
|--------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------|
| Initial shelf-life of 1 year
based on packaging
validations | 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.