DeviceClearance

Product code KWS— Orthopedic

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Classification name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class
Class 2
Regulation
21 CFR 888.3660
Advisory panel
Orthopedic
Total cleared
191
First cleared
Most recent

Market context for product code KWS

FDA has cleared 191 devices under product code KWS between 1980 and 2026, filed by 60 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 KWS

Adverse events under product code KWS

product code KWS
Death
6
Injury
9,652
Malfunction
1,385
Other
1
Total
11,044

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 KWS

1–100 of 191

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