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K Number
K971800
Device Name
OSTEO CANNULATED SCREW SYSTEM
Manufacturer
OSTEONICS CORP.
Date Cleared
1997-07-30

(76 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K980482,K971987,K923238
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Osteo Cannulated Screw System is indicated for the following:

  • Intracapsular fractures of the femoral neck .
  • . Intertrochanteric fractures of the femur
  • Tibial plateau fractures .
  • Fractures of the dorsal pelvic ring .
  • Pelvic sacroiliac joint disruptions .
  • Ankle arthrodesis .
Device Description

The Osteo Cannulated Screw System consists of three self-tapping cannulated screws of various lengths, and one washer, which can accommodate any one of the three screws. All devices in the system are provided both sterile. The three screws and washer are manufactured from Titanium 6Al-4V alloy. Two of the three screws have a thread diameter of 6.5mm. One of the two 6.5mm screws has a thread length of 20mm, while the other has a thread length of 40mm. The third screw has an 8.0mm thread diameter and a 25mm thread length. The washer has an outer diameter of 14mm and an inner diameter of 7.5mm.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) premarket notification for the Osteo Cannulated Screw System, which focuses on demonstrating substantial equivalence to predicate devices and outlining the intended use and regulatory classifications. It does not include details on performance studies, sample sizes, ground truth establishment, or expert evaluations.

§ 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.