LogoFDA 510(k) Search
K Number
K191817
Device Name
ActivOrtho Continuous Compression Screw System
Manufacturer
ActivOrtho, Inc.
Date Cleared
2019-07-26

(21 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K181610,K160427,K963192
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Activ Ortho Continuous Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.

Device Description

The ActivOrtho Continuous Compression Screw System is a cannulated Nitinol bone screw having various sizes to accommodate a variety of applications. The screws are headed, cannulated, and partially threaded. The continuous compression screw incorporates a helical expansion section in the smooth shaft of the screw which elongates as the distal thread engages bone to produce a continuous compression force across the fracture site.

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text is an FDA 510(k) clearance letter for the ActivOrtho Continuous Compression Screw System, which establishes substantial equivalence to previously marketed devices. This type of submission relies on comparisons to existing devices rather than new clinical outcome studies with predefined acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.