(23 days)
No
The document describes a mechanical implant (screws) and associated instruments for surgical fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for fixation and fusion of the sacroiliac joint to treat various conditions, indicating a therapeutic purpose to alleviate symptoms and restore function.
No
This device is a surgical implant designed for fixation and fusion of the sacroiliac joint, not for diagnosing conditions. Its primary function is therapeutic, involving physical stabilization rather than detection or analysis of medical conditions.
No
The device description explicitly states that the system includes "cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body." This indicates the device is a physical implant and associated surgical tools, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The T-FIX™ 3DSI Joint Fusion System is a system of bone screws and instruments designed to be surgically implanted into the body to fix and fuse the sacroiliac joint.
- Intended Use: The intended use is for fixation and fusion of the sacroiliac joint for various conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgically implanted device used for structural support and fusion within the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including;
· sacroiliac joint disruptions
· degenerative sacroiliitis
· to augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
· acute, non-acute and non-traumatic fractures involving the sacroiliac joint
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The T-FIX™ 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The T-FIX™ 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The T-FIX™ screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. T-FIX™ is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The T-FIX™ screws are made from a titanium alloy Ti-6Al-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment when packaged sterile.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Additional testing was performed to determine that Steam as a sterilization method will not impact the safety or efficacy of this implant. A summary of the test data is included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 5, 2023
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Cutting Edge Spine, LLC Kyle Kuntz Manager R&D 6012 Waxhaw Hwy Mineral Springs, North Carolina 28108
Re: K230689
Trade/Device Name: T-FIX™ 3DSI 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 13, 2023 Received: March 13, 2023
Dear Kyle Kuntz:
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.
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for
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
2
Indications for Use
510(k) Number (if known)
K230689
Device Name T-FIXTM 3DSI Joint Fusion System
Indications for Use (Describe)
The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including;
· sacroiliac joint disruptions
· degenerative sacroiliitis
· to augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of 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)
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510(k) Summary _
I. SUBMITTER
Date Prepared: 3/13/2023
| Applicant: | Cutting Edge Spine, LLC |
|---|---|
| 6012 Waxhaw Hwy | |
| Mineral Springs, NC 28108 | |
| Contact Person: | Kyle Kuntz, Manager R&D |
| Tel: (704) 243-0892 | |
| e-mail: k.kuntz@cuttingedgespine.com |
Application Correspondents:
| Contact Person: | Kyle Kuntz, Manager R&D |
|---|---|
| Tel: (704) 243-0892 | |
| e-mail: k.kuntz@cuttingedgespine.com | |
| Alternate Contact: | Brad Roof, Director of Operations |
| Tel: (704) 243-0892 | |
| e-mail: b.roof@cuttingedgespine.com |
II. DEVICE
| Trade Name: | T-FIX ™ 3DSI Joint Fusion System |
|---|---|
| Common or Usual Name: | Sacroiliac Joint Fixation Device |
| Classification Name: | Per 21 CFR as follows: |
| 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class: | II |
| Product Codes: | OUR |
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PREDICATE DEVICE III.
| 510(k) Number | Device | Manufacturer | |
|---|---|---|---|
| Primary | |||
| Predicate | K214123 | T-FIX TM 3DSI Joint | |
| Fusion System | Cutting Edge Spine |
DEVICE DESCRIPTION IV.
- V. The T-FIX™ 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The T-FIX™ 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The T-FIX™ screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. T-FIX™ is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The T-FIX™ screws are made from a titanium alloy Ti-6Al-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment when packaged sterile.
INDICATIONS FOR USE VI.
There are no differences between the subject device and the predicate with respect to indications and intended use.
Indications for both the subject device and the predicate:
The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;
- sacroiliac joint disruptions ●
- o degenerative sacroiliitis
- to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
- acute, non-acute and non-traumatic fractures involving the sacroiliac joint ●
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VII. DEVICES
Documentation was submitted which demonstrated that the T-FIX™ 3DSI Joint Fusion System is substantially equivalent to the predicate devices based on a comparison of the following characteristics:
- FDA product codes ●
- Indications for Use
- Surgical Approach
- Anatomical Region
- o Implant Materials
- Product Dimensions o
- Mechancial Performance
- Available by prescription only
- Made for single use
- Sterility Assurance Level (SAL) ●
- Technology
NON-CLINICAL AND CLINICAL PERFORMANCE TESTING VIII.
Additional testing was performed to determine that Steam as a sterilization method will not impact the safety or efficacy of this implant. A summary of the test data is included.
CONCLUSIONS IX.
Based upon a comparison of technological characteristics, intended use, design features, and mechanical performance, the addition of steam sterilization to the T-FIX™ 3DSI Joint Fusion System does not raise any new concerns of safety or efficacy. The data presented in this submission demonstrates that the devices listed above are substantially equivalent to the predicate devices.