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K Number
K030608
Device Name
OTI BONE CEMENT PLUG
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2003-06-12

(106 days)

Product Code
JDK
Regulation Number
878.3300
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.

Device Description

OTI Bone Cement Plug - Line extension

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "OTI Bone Cement Plug." It does not contain any information about acceptance criteria, device performance data from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

The document primarily focuses on:

  • Device Identification: OTI Bone Cement Plug
  • Regulatory Classification: Class II, Product Code JDK (Surgical mesh)
  • Substantial Equivalence Determination: FDA has determined the device is substantially equivalent to legally marketed predicate devices.
  • Limitations: A crucial warning is mandated: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
  • Indications For Use: To allow bone cement pressurization in the intramedullary canal, preventing cement seepage distally, when placed at a set distance from the proximal end of the femur prior to bone cement and femoral prosthesis placement.
  • General Controls: Mentions requirements for annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot fulfill your request for details on acceptance criteria and study information as these are not present in the provided text. This document is a regulatory clearance letter, not a study report or clinical trial summary.

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.