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K Number
K050637
Device Name
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
Manufacturer
ORTHO DEVELOPMENT CORP.
Date Cleared
2005-09-23

(196 days)

Product Code
JDI
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include:

  1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic acetabuli and painful hip dysplasia.
  2. Previously failed surgery.
  3. Proximal femoral neck fractures or dislocation.
  4. Idiopathic avascular necrosis of the femoral head.
  5. Non-union of proximal femoral neck fractures.
  6. Treatment of fractures that are unmanageable using other forms of therapy.
  7. Benign or malignant bone tumors, congenital abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a hip implant, not a study report for an AI/ML medical device. Therefore, I cannot extract the information requested as it is not present in the provided document.

The document discusses:

  • Device Name: Encompass™ Cemented Hip System
  • Regulation Number: 21 CFR 888.3350
  • Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis
  • Regulatory Class: II
  • Product Code: JDI
  • Indications for Use: Conditions like osteoarthritis, rheumatoid arthritis, fractures, avascular necrosis, etc., where a hip arthroplasty is indicated.

This document confirms the FDA's clearance of the device based on its substantial equivalence to a legally marketed predicate device, as per Section 510(k) of the Federal Food, Drug, and Cosmetic Act. It does not contain any information about performance studies, acceptance criteria, sample sizes for AI training or testing, expert ground truth adjudication, or any AI-related metrics.

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.