# PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

- Device class: 2; regulation: 21 CFR 888.3660; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 190 days (middle half 124–261)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 4
- 2021: 2
- 2022: 3
- 2023: 1
- 2024: 3
- 2025: 1
- 2026: 2

## Most-cited predicates
- K143552: Simpliciti Shoulder System (2015), cited by 10
- K171858: Sidus Stem-Free Shoulder (2017), cited by 5
- K173388: Exactech Equinoxe Stemless Shoulder (2018), cited by 4
- K240716: AETOS Shoulder System Stemless Humeral Prosthesis (2024), cited by 3
- K203108: Ignite Stemless Anatomic Shoulder System (2021), cited by 3
- K182516: Comprehensive Nano Stemless Shoulder (2019), cited by 2
- K192097: Exactech® Equinoxe® Stemless Humeral Components (2020), cited by 1
- K201542: Arthrex Eclipse Shoulder Prosthesis System (2020), cited by 1
- K241873: OsseoFit Stemless Shoulder System (2024), cited by 1
- K193226: AltiVate Anatomic Canal-Sparing (CS) Shoulder (2020), cited by 1

Source page: https://510kreport.com/product-code/PKC
Data by year (CSV): https://510kreport.com/product-code/PKC.csv