MyShoulder Planner (5.3SSWPL)

510(k)K241292OrthopedicKWS

Medacta International S.A. is listed for MyShoulder Planner (5.3SSWPL) (K241292). The FDA list gives January 30, 2025 as the date of the final decision. The lead panel is Orthopedic, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is KWS. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241292

Official FDA database record

Date of final decision: January 30, 2025
Company on the FDA list: Medacta International S.A.
Lead panel: Orthopedic
Primary product code: KWS
openFDA device name for the code: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: 2
Regulation number: 888.3660
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary