DeviceClearance

Product code PKC— Orthopedic

AETOS Shoulder System Stemless Humeral Prosthesis

Classification name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device class
Class 2
Regulation
21 CFR 888.3660
Advisory panel
Orthopedic
Total cleared
19
First cleared
Most recent

FDA classification definition

“Replacement of the humeral head for total anatomic shoulder arthroplasty”

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

Market context for product code PKC

FDA has cleared 19 devices under product code PKC between 2015 and 2026, filed by 15 applicant companies. 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.

Clearances per year

Top applicants under product code PKC

Adverse events under product code PKC

product code PKC
Injury
258
Total
258

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 PKC

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