DeviceClearance

Product code KWT— Orthopedic

AGILON® XO Shoulder Replacement System

Classification name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class
Class 2
Regulation
21 CFR 888.3650
Advisory panel
Orthopedic
Total cleared
72
First cleared
Most recent

Market context for product code KWT

FDA has cleared 72 devices under product code KWT between 1979 and 2026, filed by 33 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

last 15 years

Top applicants under product code KWT

Adverse events under product code KWT

product code KWT
Injury
2,467
Other
2
Total
2,469

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 KWT

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