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510(k) Data Aggregation
K Number
K183618Device Name
Revolution Radial Head
Manufacturer
Ignite Orthopedics, Inc.
Date Cleared
2019-05-17
(142 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
Ignite Orthopedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ignite Orthopedics Revolution Radial Head is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o 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 Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
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