(21 days)
The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.
The MODUS® Titanium Osteosynthesis System consists of implant plates, implant screws and instruments and is used for the internal fixation of fractures, correction osteotomies, the bridging of load bearing bone segments and distraction in the craniofacial skeleton. This submission includes modifications to the MODUS system plates that enhance clinical effectiveness due to improved strength or anatomical adaptation. All modifications discussed in this submission use previously cleared Medartis titanium screws.
The provided text is a 510(k) summary for a medical device modification. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study proving the device meets them, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The available text focuses on:
- Device Name: MODUS® Titanium Osteosynthesis System
- Manufacturer: Medartis, Inc.
- Predicate Device: MODUS® Titanium Osteosynthesis System from Medartis AG (originally Elekta Instruments, Inc. CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation System, K946165; and MODUS® 2.5 Mandibular Trauma Set, K992683).
- Device Classification: Class II (21 CFR 872.4760), Product Code JEY.
- Intended Use: For osteotomies and fractures involving any part of the craniofacial skeleton requiring positional and functional stability. Specific indications listed include fixation in various craniofacial areas, fixation of comminuted fractures, tumor surgery defect bridging, reconstruction of bony structures with mesh, burr hole coverings, nasal bone trauma, dentofacial deformation correction, and post-tumor surgery reconstruction.
- Device Description: The system includes implant plates, implant screws, and instruments for internal fixation. The current submission is for modifications to system plates to enhance strength or anatomical adaptation, using previously cleared Medartis titanium screws. The materials (CP titanium) meet ASTM F 67 and ISO 5832-2 standards.
- Equivalence to Marketed Product: The modified implants are considered substantially equivalent to the predicate devices due to having the same intended use, operating principle, basic design, and materials.
No performance study details or acceptance criteria are presented in this 510(k) 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.