(202 days)
The TRIGENTM Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGENTM) Titanium Nail System. The TRIGEN™ Low Profile Bone Screw therefore has the following indications:
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail. Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.
In addition to the indications for intramedulary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic fractures).
The TRIGEN™ InterTAN nails are indicated for fractures of the femur including; simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; intertrochanteric fractures; ipsilateral fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.
META-TANTM Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, META-TAN™ TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
The TRIGENTM Low Profile Bone Screw is intended for single use only.
The subject of this Special 510(k) Premarket Notification is the 5.0mm TRIGEN™ Low Profile Bone Screws. Specifically, subject devices are modified with a change in the tip. All described implant devices are manufactured from implant grade titanium alloy material (Ti-Al-4V) and designed for single use. The subject devices are provided in a sterile packaged option and will be sterilized via Gamma irradiation.
The subject devices are designed to be used with TRIGEN™ Titanium intramedullary nail systems.
This document describes a Special 510(k) Premarket Notification for the Smith & Nephew TRIGEN™ Low Profile Bone Screws, which involves a modification to the screw tip.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was measured?) | Reported Device Performance |
|---|---|
| Insertion Torque (Comparison to original design) | The modified TRIGEN™ Low Profile Bone Screws with the design change to the screw tip require less insertion torque than the predicate. This suggests superior insertion torque performance for the modified device compared to the predicate design. No specific numerical value or range is provided for acceptance criteria or specific performance, but the comparative outcome serves as the performance indicator. |
| Bacterial Endotoxin Limits (Sterility assessment) | Testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance documents: "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72. No specific numerical values for endotoxin limits or actual test results are given, but compliance with established standards is reported. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for Insertion Torque Evaluation Testing): The document does not explicitly state the sample size used for the insertion torque evaluation testing. It refers to "testing evaluated the performance of the subject device compared to the original design," but the number of devices tested is not provided.
- Data Provenance: The study appears to be a prospective in-house engineering study conducted by Smith & Nephew, Inc. No country of origin is explicitly mentioned for the data, but given Smith & Nephew's location (Memphis, Tennessee) and the FDA submission, it can be inferred that the testing was conducted under appropriate U.S. regulatory and quality standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable to this type of submission. The studies described are primarily engineering/performance evaluations, not clinical studies requiring expert ground truth for interpretation (e.g., image analysis by radiologists). The "ground truth" for insertion torque is direct measurement, and for endotoxin testing, it's compliance with established quantitative limits.
4. Adjudication Method for the Test Set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human readers/interpreters where there might be disagreement in interpretations. For mechanical testing and sterility assessments, the results are typically quantitative and objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device submission. This type of study is relevant for diagnostic devices where human readers interpret medical images. The TRIGEN™ Low Profile Bone Screw is an orthopedic implant for fixation of fractures.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
- This concept is not applicable here as this is a physical medical device (bone screw), not an AI algorithm or software device. Performance is evaluated through mechanical testing and biological safety assessments.
7. The Type of Ground Truth Used:
- For Insertion Torque Evaluation Testing: The "ground truth" is the direct measurement of insertion torque of the device itself and its comparison to the direct measurement of the predicate device.
- For Bacterial Endotoxin Testing: The "ground truth" is established by quantitative limits specified in recognized international standards (e.g., ANSI/AAMI ST72) and FDA guidance documents.
8. The Sample Size for the Training Set:
- This information is not applicable. This submission is for a physical medical device and its performance evaluation, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable as there is no training set for a physical medical device.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.