CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM

• K Number: K100599
• Device Name: CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
• Manufacturer: ORTHOSOFT, INC.
• Date Cleared: 2010-04-05 ( 33 days)
• Product Code: OLO
• Regulation Number: 882.4560
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K071929

Intended Use

CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.

Device Description

CAS Fixation Pins are threaded bone pins similar to Steinmann pins. They are used to temporarily fixate locational reference instruments to bones in order to reference their location in Computer Assisted Surgery (CAS) systems.

AI/ML Overview

This 510(k) summary describes a device, CAS Fixation Pins, which is substantially equivalent to a predicate device, the Navitrack System – Partial Hip Resurfacing Universal. The primary difference is the sterilization method. This submission does not include a study or performance data that would establish acceptance criteria for device performance related to a diagnostic or therapeutic function, nor does it involve an AI/ML algorithm.

Therefore, I cannot provide the information requested in the prompt based on the provided document because the device in question is a physical surgical instrument and the submission focuses on its equivalence in sterilization and packaging to a predicate device, not on AI-driven diagnostic or therapeutic performance.

The document states: "The proposed pin will be provided sterile using validated sterilization and packaging methods with an SAL of 10-9." This is the only "performance data" mentioned, pertaining to its sterility, not a functional or diagnostic performance. There is no mention of a "device performance" in terms of clinical outcomes or diagnostic accuracy.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).