(50 days)
Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extraarticular, intra-articular, joint depression, tongue type and severely comminuted fractures.
Synthes LCPs are designed to address complex fractures of the calcaneus and are applied to the lateral side. The plate has 15 threaded screw holes, which accept 2.7 mm and 3.5 mm cortex screws, as well as 3.0 mm locking screws. The plates are 2.0 mm thick, 69 mm and 76 mm in length, and are available for right and left placements.
I am sorry to inform you that the provided text does not contain the information requested about acceptance criteria and a study proving a device meets them.
The document is a 510(k) summary for Synthes Locking Calcaneal Plates, primarily focused on regulatory submission details. It includes:
- Device name and classification
- Predicate device
- Device description
- Intended use
- Material
- A letter from the FDA confirming substantial equivalence
- Indications for Use statement
There is no mention of:
- Acceptance criteria for performance
- Any specific study that evaluated device performance against acceptance criteria
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study results.
This document is a regulatory filing for market clearance based on substantial equivalence to a predicate device, not a performance study report.
§ 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.