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K Number
K040611
Device Name
MODULAR RADIAL HEAD REPLACEMENT DEVICE
Manufacturer
BIOMET, INC.
Date Cleared
2004-06-04

(88 days)

Product Code
KWI
Regulation Number
888.3170
Type
Traditional
Panel
OR
Reference & Predicate Devices
K012551,K984290,K002644,K991915
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Modular Radial Head Replacement Device is intended for:

  1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
    a) Joint destruction and/or subluxation visible on x-ray
    b) Resistance to conservative treatment
  2. Primary replacement after fracture of the radial head
  3. Symptomatic sequelae after radial head resection
  4. Revision following failed radial head arthroplasty
    The device is intended for single use with bone cement.
Device Description

The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6Al-4V) and a head (Co-Cr-Mo). The tapered stem is cemented into the intramedullary canal of the radius. The head has a highly polished concave surface to articulate with the natural bone of the humerus and ulna. The proximal portion of the stems are roughened with a Bond Coat surface. The components connect via a dove-tail joint secured by a locking screw. The device is available in three diameters, 18mm, 20mm and 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) premarket notification for a medical device (Modular Radial Head Replacement Device).

Here's what the document indicates:

  • Non-Clinical Testing and Clinical Testing: The document explicitly states "none provided as a basis of substantial equivalence." This means no new testing was submitted to demonstrate the device's performance against specific acceptance criteria.
  • Substantial Equivalence: The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway relies on demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market, rather than requiring new performance studies against predefined acceptance criteria.

Therefore, since no study was conducted or reported in this document to demonstrate performance against acceptance criteria, most of the requested information cannot be extracted.

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.