(280 days)
Not Found
No
The summary describes a system of mechanical implants and instruments for bone fixation and reconstruction, with no mention of software, algorithms, or AI/ML capabilities. Performance studies are based on mechanical testing.
Yes.
The device is intended for bone-to-bone fixation and reconstructive surgeries, which are therapeutic interventions.
No
The device is described as a system for bone-to-bone fixation and management of reconstructive surgeries, which are treatment procedures, not diagnostic functions.
No
The device description explicitly states the system includes "reconstruction devices" and "instruments" for placement, which are physical hardware components, not software.
Based on the provided information, the Tigon Medical FIRE System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "bone-to-bone fixation" and "management of reconstructive surgeries." This involves physically implanting devices to stabilize bone, which is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details "reconstruction devices" and "instruments that allow for the placement of the reconstruction device and screws." This aligns with surgical implants and tools, not diagnostic reagents or analyzers.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing (torsional strength, torque, pullout strength), which is relevant to the structural integrity of implants, not the accuracy of a diagnostic test.
- Predicate Devices: The predicate devices listed (Latarjet Cortical Screw Set, Arthrex Low Profile Plate and Screw System) are also surgical implants used for bone fixation, further supporting that this device falls under the category of orthopedic surgical devices, not IVDs.
In summary, the Tigon Medical FIRE System is a surgical device intended for orthopedic procedures, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries.
-
Bone Loss Deficiencies/Deformities
- · Latariet
- Free bone block
-
Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.
Product codes
HWC, HRS
Device Description
The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System includes reconstruction devices that are designed to provide a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. The system includes instruments that allow for the placement of the reconstruction device and screws. The reconstruction devices and screws are available in various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, hand, and wrist.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeon
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)
Mechanical testing was performed according to ASTM F543 and ASTM F382. The FDA guidance documents, Orthopedic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway and Orthopedic Fracture Fixation Plates -Performance Criteria for Safety and Performance Based Pathway, were utilized to prove substantial equivalence. The mechanical test data demonstrates that the torsional strength, torque, and pullout strength have met the acceptance criteria for the proposed indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 29, 2024
Tigon Medical Jeremy Clark President 303 Najoles Rd. Suite 104 Millersville, Maryland 21108
Re: K240175
Trade/Device Name: Tigon Medical Fractures, Instability, and Reconstruction (FIRE) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: October 3, 2024 Received: October 4, 2024
Dear Jeremy Clark:
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.
1
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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K240175
Device Name
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
Indications for Use (Describe)
The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries.
-
Bone Loss Deficiencies/Deformities
- · Latariet
- Free bone block
-
Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.
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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4
K240175 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange and black, and the text is black.
Submitter Information
| Applicant: | Tigon Medical |
|---|---|
| Contact Person: | Jeremy Clark |
| Management Representative | |
| Tigon Medical | |
| 303 Najoles Rd. | |
| Millersville, MD 21108 | |
| (410) 544-2833 | |
| 510(k) Number: | K240175 |
| Date Prepared: | 03OCT2024 |
| Name of Device: | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) |
| System | |
| Common Name: | Screw, Fixation, Bone |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation |
| fastener. | |
| Product Code/Panel: | HWC, HRS |
| Predicate Devices: | Latarjet Cortical Screw Set (K083096) |
| Arthrex Low Profile Plate and Screw System (K052614) |
Intended Use:
The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries.
- Bone Loss Deficiencies/Deformities
- o Latarjet
- o Free bone block
- Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.
5
K240175 510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange and black, and the text is black.
Device Description Summary:
The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System includes reconstruction devices that are designed to provide a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. The system includes instruments that allow for the placement of the reconstruction device and screws. The reconstruction devices and screws are available in various sizes.
Non-Clinical Testing Summary:
Tigon Medical substantiates that the product is as safe, as effective, and performs as well as or better than the legally marketed predicate.
Mechanical testing was performed according to ASTM F543 and ASTM F382. The FDA guidance documents, Orthopedic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway and Orthopedic Fracture Fixation Plates -Performance Criteria for Safety and Performance Based Pathway, were utilized to prove substantial equivalence. The mechanical test data demonstrates that the torsional strength, torque, and pullout strength have met the acceptance criteria for the proposed indications.
Substantial Equivalence Summary:
The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System is substantially equivalent to the predicate devices as the features and intended uses are the same. Any variations between the candidate devices and the predicate devices are considered minor and do not raise any issues concerning safety or effectiveness. The mechanical test data demonstrates that the torsional strength, torque, and pullout strength have met the acceptance criteria for the proposed indications.