OMX — High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis Class f
FDA product code OMX covers "High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- OMX
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Unknown
- Implant
- Yes
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.