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The Aptis Medical Distal Radio Ulnar Joint implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint - Failed ulnar head resection; e.g. Darrach resection - Primary replacement after fracture of the ulnar head or neck. - Revision following failed ulnar head arthroplasty. This prosthesis is intended for single use only.

The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including; Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head. The device consists of a plate of various sizes which is fixed to the radius and a stem of various sizes which is fixed to the ulna.

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint - Failed ulnar head resection; eg. Darrach resection - Primary replacement after fracture of the ulnar head or neck. - Revision following failed ulnar head arthroplasty.

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment . - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint - Failed ulnar head resection; eg. Darrach resection . - Primary replacement after fracture of the ulnar head or neck. . - Revision following failed ulnar head arthroplasty. .

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: - Pain and weakness of the wrist joint not improved by non-operative treatment - Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint - Failed ulnar head resection; eg. Darrach resection - Primary replacement after fracture of the ulnar head or neck. - Revision following failed ulnar head arthroplasty.

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.