(16 days)
The I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
The I.T.S. Pilonplate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 4.5mm Cortical screws of various lengths are self-tapping and secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
The provided text describes a medical device, the "Pilonplate with Angular Stability," and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence to previously marketed devices rather than presenting performance study results against specific criteria.
Therefore, I cannot populate the requested table and answer questions 2 through 9 based solely on the provided text. The document confirms:
- Device Name: Pilonplate with Angular Stability
- Intended Use: Fixation of complex intra- and extra-articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
- Substantial Equivalence: The basis of substantial equivalence is to Synthes, DePuy/ACE, Link America, and Zimmer bone plate systems.
- Claim of Safety and Effectiveness: "The I.T.S. Pilonplate with Angular Stability is shown to be safe and effective for use in fracture fixation of the distal tibia in the leg." However, no study data or acceptance criteria are presented to support this claim in this document.
§ 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.