(76 days)
Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Synthes DHS/DCS One-Step Lag Screw has a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The DHS/DCS One-Step is manufactured from stainless steel. Additionally, Synthes Ti-DHS/DCS One-Step Lag Screw and DHS/DCS Lag Screws have a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The Ti-DHS/DCS One-The DHS/DCS Lag Screw is Step Lag Screw is manufactured from Titanium Alloy. manufactured from stainless steel. Synthes DHS/DCS One-Step Lag Screw will be provided sterile; gamma radiation will be used to sterilize the device.
This document does not contain information about acceptance criteria or a study proving that a device meets those criteria.
This document describes the Synthes DHS/DCS One-Step Lag Screws, their intended use, and a comparison to other similar Synthes lag screws. It primarily focuses on:
-
Device Description:
- Synthes DHS/DCS One-Step Lag Screws for use with Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates.
- Intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures.
- Available in 12.7 mm or 14.0 mm thread diameter and various lengths, manufactured from stainless steel.
- Sterilized by gamma radiation.
-
Comparison/Equivalence:
- States that Synthes DHS/DCS One-Step Lag Screws are compared to Synthes Ti DHS/DCS Lag Screws and Synthes DHS/DCS Lag Screws.
- Mentions that Ti-DHS/DCS One-Step Lag Screws are made from Titanium Alloy, and DHS/DCS Lag Screws are made from stainless steel.
- Concludes that the Synthes DHS/DCS One-Step Lag Screw is equivalent to the Synthes Ti-DHS/DCS One-Step Lag Screw and the Synthes DHS/DCS Lag Screw.
No study details, acceptance criteria, or performance metrics are provided in this document. It reads like a summary for regulatory submission (e.g., a 510(k) summary) rather than a clinical study report. Therefore, I cannot extract the requested information.
§ 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.