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K Number
K100707
Device Name
REPROCESSED PINS
Manufacturer
STERILMED, INC.
Date Cleared
2010-06-25

(105 days)

Product Code
NDM
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The pins are intended to be used to rigidly fixate a Tracker to a single bone during computer assisted surgical procedures including hip, knee, and other trauma applications. Specifically:

  • Navigation and Ortholock Ex-Pins: The intended use of the Stryker OrthoLock Ex-Pins is to . rigidly fixate a Tracker to the bone undergoing treatment. The Stryker OrthoLock Ex-Pins are intended to be used with, but are not limited to, the OrthoLock system.
  • Anchoring Pins: The Anchoring Pins are components of the Hip, Trauma and Knee Modules of . the Stryker Navigation System and intended to be used to rigidly fixate a Tracker to a single bone.
Device Description

Reprocessed Pins

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding "Reprocessed Pins" by SterilMed, Inc. It does not contain the detailed information required to answer your questions about acceptance criteria and study particulars for a device performance study.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has a similar intended use, technological characteristics, and safety and effectiveness profile. The Indications for Use are provided, stating the pins are intended to rigidly fixate a Tracker to a single bone during computer-assisted surgical procedures.

However, the letter does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts and their qualifications for ground truth establishment.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information about a standalone (algorithm only) performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

These details would typically be found in the 510(k) submission itself, or in a more detailed summary of safety and effectiveness data, which is not provided in the snippet. The FDA's 510(k) decision letter focuses on regulatory approval based on substantial equivalence, rather than detailing the specifics of the underlying performance studies.

§ 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.