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K Number
K033856
Device Name
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
Manufacturer
PETER STEVENS, MD
Date Cleared
2005-01-07

(393 days)

Product Code
KTT,HWC
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This pediatric surgical implant is designed for the following intended purposes:

    1. To engage long bones including the femur, tibia, humerus, radius or ulna and permit the bone(s) to be secured to an external fixator or frame via a locking bolt.
    1. Thus to stabilize bone fragments to provide fracture alignment and stability; or
    1. Thus to stabilize bones that have been surgically cut in order to correct deformities including angular, rotational or length discrepancy.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (5.0mm and 6.0mm Cannulated Drill Pins), along with its Indications for Use. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details required to answer your request regarding a study that proves the device meets acceptance criteria.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies against pre-defined acceptance criteria as would be typical for a novel device or a significantly different technology.

Therefore, I cannot extract the requested information from the provided text.

§ 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.