High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
OMX · f · Unknown
Classification
FDA Product Code
OMX
Device class
f
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.