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510(k) Data Aggregation
K Number
K081025Device Name
ISOELASTICU
Manufacturer
REMI SCIENCES, INC.
Date Cleared
2008-11-21
(225 days)
Product Code
KXE, KXF
Regulation Number
888.3810Why did this record match?
Applicant Name (Manufacturer) :
REMI SCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications
- -Rheumatoid arthritis with or without tendon ruptures
- -Degenerative arthritis or post traumatic arthritis
- 1. Arthrofibrosis of the DRUJ o
- 2. Reconstruction of the distal ulna post tumor resection o
- 3. Failed Ulnar Head Resection 0
- 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
- 5. Revision following failed ulnar head arthroplasty O
- Ulna stems are intended for uncemented use -
Device Description
The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.
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