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K Number
K961360
Device Name
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
Manufacturer
ENCORE ORTHOPEDICS, INC.
Date Cleared
1997-03-13

(338 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
K813371,K893377,K914371
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TRUE/FIT™ Femoral Intramedullary Rod System is intended as an implantable device for the fixation of the following types of femoral fractures:

  • a. femoral shaft fractures
  • b. high and low subtrochanteric fractures of the femur (femoral shaft fractures distal to the proximal portion of the lesser trocahanter)
  • c. intertrochanteric femoral fractures
  • d. femoral neck fractures
  • e. ipsilateral femoral neck and shaft fractures
Device Description

TRUE/FIT™ Femoral Intramedullary Rod System (Ti-6A1-4V) consists of:

    1. Distal Segment
    • Transcorticle Interlocking Screws A.
  • Proximal Segments 2.
    • Standard Segment A.
    • Dynamic Compression Segment B.
      • Locking Bolt a.
      • Dynamic Compression Bolt b.
      • End Caps C.
      • Transcorticle Interlocking Screws d.
    • C. Recon/Oblique Segment
      • Recon Cancellous Screws a.
      • Oblique Screws b.
      • Transcorticle Interlocking Screws c.
AI/ML Overview

I'm sorry, but based on the provided text, I cannot answer your request. The document describes a medical device, its components, intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as outlined in your prompt.

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.