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510(k) Data Aggregation
K Number
K132735Device Name
AXIA RADIAL HEAD SYSTEM
Manufacturer
IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
Date Cleared
2014-01-07
(126 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Radial head arthroplasty
The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow.
- Radial head replacement for degenerative or post-traumatic disabilities when presenting with . pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- 0 Joint destruction and/or subluxation
- Resistance to conservative treatment O .
- Primary radial head replacement after fracture
- Symptomatic sequelae after radial head resection ◆
- Revision following failed radial head arthroplasty .
CAUTION: This device is intended for uncemented use only.
Device Description
The Axia Radial Head System is a 2-part system comprised of a radial head implant and a radial stem implant. There are 6 sizes of radial heads and 6 sizes of stem implant is available in 3 offset sizes. The large combination of implant sizes and the amount size interchangeability in the system allows for better reproduction of individual patient anatomy.
The Axia Radial Head System radial head implants are made from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. The radial head stems are made from titanium alloy (Ti-6Al-4V).
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