FDA Product Code PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
FDA product code PKC covers uncemented metal total anatomic shoulder prostheses cleared for shoulder arthroplasty.
These implants achieve fixation through biological ingrowth or ongrowth into porous-coated surfaces rather than bone cement. Uncemented fixation is preferred in younger, more active patients where long-term biological fixation may outperform cemented alternatives.
PKC devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Tornier, Inc. and Lima Corporate S.P.A..
List of Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained devices (product code PKC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →