# K143552: Simpliciti Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Mar 4, 2015 after 79 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911686 (1991). 9 ancestors in all.
24 later devices descend from it; 10 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103007: Affiniti Total and Hemi-Shoulder System, Tornier, Inc. (2010) Summary page 4.

## Most influential descendants
- K171858: Sidus Stem-Free Shoulder (2017), 13 descendants of its own
- K173388: Exactech Equinoxe Stemless Shoulder (2018), 9 descendants of its own
- K183194: Arthrex Eclipse Shoulder Prosthesis System (2019), 8 descendants of its own
- K182516: Comprehensive Nano Stemless Shoulder (2019), 6 descendants of its own
- K193226: AltiVate Anatomic Canal-Sparing (CS) Shoulder (2020), 4 descendants of its own

## Indications for use
The SimplicitiTM Shoulder System is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The metaphyseal humeral stems are indicated for press-fit, un-cemented use. The glenoid components are indicated for cemented use only and are indicated only for use with bone cement. This device is for single use.

Source page: https://510kreport.com/device/K143552
Methodology: https://510kreport.com/methodology