(308 days)
ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
- comminuted fractures
- supracondylar fractures
- extra-articular fractures
- fractures in osteopenic bone
- nonunions
- malunions
Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.
ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically,
- Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
- Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.
ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.
ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.
ARMARTM / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.
This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically bone plates and screws. It does not contain information about an AI/ML device, AI acceptance criteria, or a study proving an AI device meets acceptance criteria.
Therefore, I cannot extract the requested information regarding AI device performance, acceptance criteria, sample sizes, expert ground truth, MRMC studies, or training/test set details from this document. The document describes the substantial equivalence of bone fixation appliances to existing predicate devices based on technological characteristics and mechanical performance data (e.g., static four-point bending, dynamic four-point bending, static torsion, static axial pullout).
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.