(102 days)
Not Found
No
The summary describes a mechanical implant system and associated surgical tools, with no mention of software, algorithms, or any technology related to AI or ML. Performance testing is based on mechanical standards.
No
The device is described as an implant system for fixation of bones during surgical procedures, not for treating or rehabilitating a condition.
No
The device is described as an implant system for fixation of bones, used to correct deformities, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details physical implants (cannulated, threaded, spaded implants, k-wire implants) and instrumentation (spade pilot drills, spade drivers, thread pilot drills, reamers, impactor, handles), indicating it is a hardware-based medical device.
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 Two-Step Implant System is described as a system for the fixation of bones in the foot and hand. It includes implants, k-wires, and surgical instrumentation.
- Intended Use: The intended use is for surgical procedures to correct deformities of the toes and fingers by fixing osteotomies and reconstructing bones.
There is no mention of this device being used to test samples from the body or to provide diagnostic information based on such tests. It is a surgical implant system used directly on the patient's bones during a procedure.
N/A
Intended Use / Indications for Use
The Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the bones of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.
Product codes
HWC, HTY
Device Description
The Two-Step Implant System is used for fixation of the bones of the foot and hand. The system includes a cannulated, threaded, spaded implant that is offered in multiple threaded diameters, lengths, and spade diameters. The system includes k-wire implants in multiple sizes. Available implants and instrumentation can be packaged in a sterilization tray as a single system. System instrumentation includes spade pilot drills, spade drivers, thread pilot drills, reamers, impactor, and handles to facilitate the placement of the implants. The Two-Step Implant System implants and k-wires are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and hand (toes and fingers)
Indicated Patient Age Range
Not Found
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
Non-Clinical Performance Summary: Performance testing is presented per methods developed from ASTM F543 to demonstrate equivalence to predicates in terms of established performance specifications.
Clinical Test Summary: No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Hammer Toe Implant (Trilliant Surgical, K122959), Tiger Headless Cannulated Screws (Trilliant Surgical, K112737), Trilliant Surgical K-Wires (Trilliant Surgical, K121008), KMedic External Fixation Devices - (Teleflex Medical Group, K030336)
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
October 26, 2018
Image /page/0/Picture/1 description: The image contains 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.
Trilliant Surgical Jon Olson President 727 N Shepherd Dr. STE 100 Houston, Texas 77007
Re: K181898
Trade/Device Name: Two-Step Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: September 19, 2018 Received: September 20, 2018
Dear Mr. Jon Olson:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S 2018.10.26 12:17:00 -04'00'
For:
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181898
Device Name Two-Step Implant System
Indications for Use (Describe)
The Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.
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 Two-Step Implant System
In accordance with 21 CFR 807.92(c) of the Federal Code of Regulations, the following 510(k) summary is submitted for the Two-Step Implant System.
l. GENERAL INFORMATION
| Date Prepared | September 19th, 2018 |
|---|---|
| Submitted By | Trilliant Surgical |
| 727 N. Shepherd Drive, Suite 100 | |
| Houston, TX 77007 | |
| Telephone: (800) 495-2919 | |
| Fax: (877) 778-3864 | |
| Contact: Gabriel Kern | |
| Email: gkern@trilliantsurgical.com | |
| Trade Name | Two-Step Implant System |
| Regulatory Class | Class II |
| CFR Section, | |
| Product Code, | |
| Classification Name, | |
| and Common Name | 21 CFR Section 888.3040, Product Code HWC, Screw, Fixation, |
| Bone, threaded metallic bone fixation fastener, bone screw | |
| 21 CFR Section 888.3040, Product Code HTY, Pin, Fixation, | |
| Smooth, smooth metallic bone fixation fastener, k-wire | |
| Device Panel | Orthopedic |
| Primary Predicate Device | Hammer Toe Implant (Trilliant Surgical, K122959) |
| Secondary Predicate | Tiger Headless Cannulated Screws (Trilliant Surgical, K112737) |
| Devices | Trilliant Surgical K-Wires (Trilliant Surgical, K121008) |
| KMedic External Fixation Devices - (Teleflex Medical Group, | |
| K030336) |
II. DEVICE DESCRIPTION
The Two-Step Implant System is used for fixation of the bones of the foot and hand. The system includes a cannulated, threaded, spaded implant that is offered in multiple threaded diameters, lengths, and spade diameters. The system includes k-wire implants in multiple sizes. Available implants and instrumentation can be packaged in a sterilization tray as a single system. System instrumentation includes spade pilot drills, spade drivers, thread pilot drills, reamers, impactor, and handles to facilitate the placement of the implants. The Two-Step Implant System implants and k-wires are intended for single use only.
4
= Indications for Use
The Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the bones of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.
IV. Technological Comparison to Predicate Devices
The Two-Step Implant System has the same technological characteristics as one or more predicate devices in terms of design, material, performance, and energy source.
V. Non-Clinical Performance Summary
Performance testing is presented per methods developed from ASTM F543 to demonstrate equivalence to predicates in terms of established performance specifications.
VI. Clinical Test Summary
No clinical studies were performed.
VII. Conclusions
Based upon the similarities in indications for use, technology, materials, and performance, Trilliant Surgical considers the Two-Step Implant System to be as safe and effective as predicate devices and performs as well as predicate devices.
VIII. Substantial Equivalence Claimed to Predicate Devices
The Two-Step Implant System is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance specifications.