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K Number
K030384
Device Name
EVOLVE CERAMIC RADIAL HEAD IMPLANT
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2003-08-12

(188 days)

Product Code
KWI
Regulation Number
888.3170
Type
Special
Panel
OR
Reference & Predicate Devices
K991915,K960659
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Use of the Modular Radial Head Implant may be considered for :

  • . Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
    • a. joint destruction and/or subluxation visible on x-ray; and/or
    • b. resistance to conservative treatment.
  • Primary replacement after fracture of the radial head.
  • Symptomatic sequelae after radial head resection. .
  • Revision following failed radial head arthroplasty. ●
Device Description

The EVOLVE® Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 510(k): K991915- EVOLVE® Modular Radial Head. The only difference between the two devices is the type of materials used to manufacture the head components. The EVOLVE® Modular Radial Head system is approved with a CoCr head component, and a CoCr stem component. Wright Medical Technology is now adding a ceramic head component for use with the CoCr stem component previously cleared under the EVOLVE® Modular Radial Head (510(k): K991915).

The design features for both EVOLVE® radial head components are as follows:

  • The proximal portion of the radial head will have a concave design to provide . stability to the bearing surface and closely approximate the natural anatomy of the radial head and humeral-capitellum articulating surface.
  • The sides of the head are designed with a radius of curvature that articulates with the . proximal radial-ulnar joint and closely approximates the natural anatomy.
  • The heads are interchangeable, since the interface has the same dimensions ● throughout the system.
  • Heads are available in 2.0mm increments, ranging from 20.0mm to 28.0mm in . diameter.
AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (EVOLVE® Ceramic Radial Head Implant), focusing on its substantial equivalence to previously cleared devices.

Therefore, I cannot extract the requested information.

§ 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.