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K Number
K090208
Device Name
BIOPRO FEMORAL HEADS
Manufacturer
BIOPRO, INC.
Date Cleared
2009-05-22

(114 days)

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

The BioPro Femoral Heads are indicated for use for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis; revision of failed femoral head replacement, cup arthroplasty, or other hip procedures; proximal femoral fractures, avascular necrosis of the femoral head; non-union of proximal femoral neck fractures; other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The BioPro hip system (PSL) is for cemented and non-cemented use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Biopro Femoral Heads," indicating that the device is substantially equivalent to legally marketed predicate devices.

The text specifies:

  • Trade/Device Name: Biopro Femoral Heads
  • Regulation Number: 21 CFR 888.3358
  • Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
  • Regulatory Class: II
  • Product Code: LPH, JDI
  • 510(k) Number: K090208
  • Indications For Use: For significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis; revision of failed femoral head replacement, cup arthroplasty, or other hip procedures; proximal femoral fractures, avascular necrosis of the femoral head; non-union of proximal femoral neck fractures; other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The BioPro hip system (PSL) is for cemented and non-cemented use.

However, it does not include any details on:

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

This document is a regulatory approval letter, not a study report or a summary of performance data.

§ 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.