PAO — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class II

FDA Device Classification

Classification Details

Product Code
PAO
Device Class
Class II
Regulation Number
888.3660
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201315tornierPERFORM Humeral System – StemSeptember 11, 2020