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K Number
K050607
Device Name
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
Manufacturer
SYNTHES (USA)
Date Cleared
2005-04-11

(32 days)

Product Code
HRS
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

The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.

Device Description

The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head profile with rounded edges with a cruciform recess, and are available in lengths from 2 -- 4 mm.

AI/ML Overview

This document is a 510(k) Summary and FDA clearance letter for a medical device, the Synthes 1.0mm Ti. Cortex, Self-drilling Screws. It does NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) process for medical devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study with acceptance criteria in the same way one might for a novel AI/software device.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on:

  • Sponsor and Device Information: Synthes (USA), 1.0mm Ti. Cortex, Self-drilling Screws.
  • Intended Use: Fracture fixation in hand surgery and neurosurgery.
  • Classification: 21 CFR 888.3040 (Smooth or Threaded Metallic Bone Fixation Fastener), Class II.
  • Predicate Devices: Synthes 1.0 / 1.2 mm Plusdrive Screws and KLS Martin 1.0mm System Center-Drive Screw System.
  • Substantial Equivalence: The primary claim is that the device is substantially equivalent to existing legally marketed devices, meaning it has the same intended use, technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.

There are no details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  6. Standalone performance studies.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

These kinds of details are typically pertinent to the evaluation of software as a medical device (SaMD) or AI-based devices, which are not applicable to the physical bone screw described here.

§ 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.