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K Number
K961625

Validate with FDA (Live)

Device Name
QUATROLOC FEMORAL COMPONENT & HEAD
Manufacturer
WHITESIDE BIOMECHANICS, INC.
Date Cleared
1996-09-10

(137 days)

Product Code
LPH
Regulation Number
888.3358
Type
Traditional
Panel
Orthopedic
Age Range
All
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to be used for :

  • noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
    1. rheumatoid arthritis,
  • correction of functional deformity, 3.
  • revision procedures where other treatments or devices have failed, and 4.
  • treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
Device Description

The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AJ- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. Th distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, specifically a modular femoral component and head for hip replacement. This document primarily focuses on describing the device, its intended use, and manufacturing materials.

It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any form of clinical or performance data that would typically be described in the context of device validation or verification studies.

Therefore, I cannot provide the requested information. The document is a regulatory submission summary, not a study report.

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SEP 10 1996

510(k) SUMMARY

Device:

Classification Name:

Prosthesis Hip, Semi-constrained, Metal / Polymer, Porous Uncemented

Classification No .: Common / Usual Name: Proprietary Name:

87LPH Modular femoral component and head Quatroloc Femoral Component and Head

Manufacturer Identification:

Whiteside Biomechanics. Inc. 12634 Olive Blvd. Creve Coeur, MO 63141

Establishment Registration Number: 1932213

Device Description:

The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AJ- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. Th distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion.

Intended Use:

This device is intended to be used for :

  • noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
    1. rheumatoid arthritis,
  • correction of functional deformity, 3.
  • revision procedures where other treatments or devices have failed, and 4.
  • treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.

Additional Information:

This femoral component is made of wrought titanium 6A1-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunnion. The porous coating will consist of 3 layers (0.030" total thickness) of commercially pure titanium beads The device is to be sterilized with 100% ethylene oxide and nitrogen in (-45+60Mesh). accordance with AAMI guidelines for sterilization.

N/A