(29 days)
No
The summary describes a mechanical implant for sacroiliac joint fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like dysfunction, degenerative sacroilitis, and fractures, which are therapeutic interventions.
No
Explanation: The device, the TransLoc 3D Screw and Posterior Implant, is described as an implantable device intended for sacroiliac joint fusion to immobilize and stabilize the joint. Its purpose is therapeutic (fusion), not diagnostic (identifying a condition).
No
The device description explicitly states that the TransLoc 3D implants are titanium 3D-printed devices, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the TransLoc 3D Screw and Posterior Implant are intended for surgical implantation to fuse the sacroiliac joint. This is a physical intervention within the body, not a test performed on a sample outside the body.
- Lack of Diagnostic Information: The document does not mention any diagnostic capabilities, analysis of biological samples, or the provision of information for diagnosis.
Therefore, the TransLoc 3D Screw and Posterior Implant are medical devices intended for surgical treatment, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.
Product codes
OUR, HWC
Device Description
TransLoc 3D implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone and may be used in the same procedure with CornerLoc bone graft. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint. All implants are provided sterile packaged for single use. Non-sterile instruments are available to assist with the surgical procedure and must be sterilized prior to use.
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
Not Found
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
Engineering analysis demonstrated that the modifications associated with this submission do not present a new worst-case construct and do not impact the performance of the device, including with respect to mechanical testing. Additional performance testing was not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 17, 2023
Foundation Fusion Solutions, LLC (dba CornerLoc) % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Ave.. Suite 106 Carlsbad. California 92008
Re: K232878
Trade/Device Name: TransLoc 3D Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: September 14, 2023 Received: September 18, 2023
Dear Jeffrey Brittan:
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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.
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-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,
Image /page/1/Picture/6 description: The image contains the name "Colin O'neill -S" in black font on the left side of the image. On the right side of the image, there is a faded logo of the letters "FDA". The logo is light blue and is partially obscured by the name.
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
2
Indications for Use
510(k) Number (if known) K232878
Device Name TransLoc 3D
Indications for Use (Describe)
The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same 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) |
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3
510(k) Summary
DATE PREPARED
October 16, 2023
MANUFACTURER AND 510(k) OWNER
Foundation Fusion Solutions, LLC dba CornerLoc 11916 S. Oxford Ave., Suite 206 Tulsa, OK 74137 USA Telephone: (417) 309-9459
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan Vice President of Product Realization Watershed Ideas Foundry Telephone: (714) 287-6780 Email: jeffbrittan(@watershedideas.com
PROPRIETARY NAME OF SUBJECT DEVICE
TransLoc 3D
COMMON NAME Sacroiliac joint fixation device
DEVICE CLASSIFICATION
Smooth or threaded metallic bone fixation fastener (Classification Regulation: 21 CFR 888.3040, Product Codes: OUR, HWC, Class: II)
PREMARKET REVIEW
Orthopedic Panel
INDICATIONS FOR USE
The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:
- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and . degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. .
The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the TransLoc 3D Posterior Implant is implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.
4
DEVICE DESCRIPTION
TransLoc 3D implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone and may be used in the same procedure with CornerLoc bone graft. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint. All implants are provided sterile packaged for single use. Non-sterile instruments are available to assist with the surgical procedure and must be sterilized prior to use.
PREDICATE DEVICE IDENTIFICATION
TransLoc 3D is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Manufacturer & Device Name |
|---|---|
| K211496 | Foundation Fusion Solutions, LLC dba CornerLoc |
| TransLoc 3D (Primary Predicate) |
K223819, Alevio, LLC SI-Cure Sacroiliac Fusion System and K222512, OsteoCentric Technologies Integrity-SI Fusion System, and K021932, Synthes 6.5mm Cannulated Screw are also cited in this submission.
SUMMARY OF NON-CLINICAL TESTING
Engineering analysis demonstrated that the modifications associated with this submission do not present a new worst-case construct and do not impact the performance of the device, including with respect to mechanical testing. Additional performance testing was not required.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
CornerLoc believes that TransLoc 3D is substantially equivalent to the predicate TransLoc 3D devices. The subject device has the same design, materials, manufacturing methods, and sterilization, and it continues to have the same intended use to bridge both sides of the SI joint to prevent motion. These technological characteristics have undergone analysis to ensure the subject device is equivalent to the predicate.
CONCLUSION
Based on the analysis performed it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate device. The indications for use, technological characteristics, and performance characteristics for the proposed TransLoc 3D updates are assessed to be substantially equivalent to the predicate.