(90 days)
The MODUS® TriLock® 2.0/2.3/2.5 is intended for use in the mandible and mid-face region for osteotomies, severe fractures and comminuted fractures. These fractures may include condylar neck fractures, mandibular angle fractures of the atrophic mandible and fractures of the orbita and zygoma complex. Mandibular reconstruction may be performed with free or vascular bone graft.
MODUS® TriLock® 2.0/2.3/2.5 is a fixation system for use in mandibular and midface trauma and reconstruction. It consists of implant plates and implant screws. Manual surgical instruments, Class I exempt and not a subject of this submission, are included in the system. The plates of the subject system are the same as plates included in the previously cleared predicate Modus Titanium Osteosynthesis System (K050934), except that the screw holes of the subject system plates are designed to accommodate TriLock Hexadrive® 6 locking screws. The MODUS® TriLock® 2.0/2.3/2.5 will be packaged and sold non-sterile and must be sterilized prior to use. The device is not represented to be "pyrogen free." Medartis recommends sterilization in the specially designed sterilization containers, instrument trays and implant containers.
This document is regarding a 510(k) premarket notification for a medical device called MODUS® Trilock® 2.0/2.3/2.5. It is a bone plate system intended for use in the mandible and mid-face region for various types of fractures and reconstruction.
Based on the provided text, none of the requested information about acceptance criteria, study data, ground truth, or expert involvement is present.
This 510(k) summary focuses on establishing substantial equivalence to previously cleared predicate devices, detailing:
- Administrative information (manufacturer, contact, etc.)
- Device name, classification, and intended use
- Device description
- Comparison to predicate devices to demonstrate substantial equivalence in terms of intended use, operating principle, basic design, materials, and sterilization.
- The FDA's decision letter acknowledging the substantial equivalence and permitting marketing.
The document does not contain information typically found in a clinical or performance study report, such as:
- Acceptance criteria and reported device performance: No specific performance metrics (e.g., strength, durability, biocompatibility test results) or the criteria these results needed to meet are mentioned.
- Sample size and data provenance: No test samples (e.g., patient cases, specific materials tested) are detailed for any study.
- Number of experts and qualifications: No experts are mentioned as having established ground truth or reviewed data.
- Adjudication method: Not applicable as no expert review process is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is a physical implant device, not an AI or imaging diagnostic tool that would typically involve human readers.
- Standalone performance: Not applicable for a physical implant device in the same way it would be for an algorithm.
- Type of ground truth: No ground truth is mentioned.
- Training set sample size: Not applicable as this is not a machine learning device.
- Ground truth for training set: Not applicable.
The FDA's 510(k) process for this type of device (bone plates) primarily relies on demonstrating substantial equivalence to already legally marketed devices, often through non-clinical performance testing (e.g., mechanical testing, biocompatibility) rather than extensive clinical studies with human subjects or AI performance evaluations, which are not outlined in this summary.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.