DeviceClearance

Product code PAO— Orthopedic

PERFORM Humeral System Stem

Classification name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Device class
Class 2
Regulation
21 CFR 888.3660
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PAO under 21 CFR 888.3660, via openFDA

Market context for product code PAO

FDA has cleared 1 device under product code PAO, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PAO

Adverse events under product code PAO

product code PAO
Injury
273
Total
273

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PAO

Data sourced from openFDA. This site is unofficial and independent of the FDA.