# K171858: Sidus Stem-Free Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Dec 18, 2017 after 180 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911686 (1991). 21 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 4.
- K982981: New Zimmer Shoulder System, Zimmer, Inc. (1998) Summary page 4.

## Most influential descendants
- K183194: Arthrex Eclipse Shoulder Prosthesis System (2019), 8 descendants of its own
- K182516: Comprehensive Nano Stemless Shoulder (2019), 6 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K241873: OsseoFit Stemless Shoulder System (2024), 1 descendant of its own
- K201542: Arthrex Eclipse Shoulder Prosthesis System (2020), 1 descendant of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0300-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0318-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Aug 21, 2019 · Class II · Z-2762-2019: Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.

## Indications for use
The Indications for Use of the Sidus Stem-Free Shoulder are: - Osteoarthritis; - Posttraumatic arthrosis; - Focal avascular necrosis of the humeral head; - Previous surgeries of the shoulder that do not compromise the fixation. The Sidus Stem-Free Shoulder components (Anchors and Humeral Heads) are intended for cementless use.

Source page: https://510kreport.com/device/K171858
Methodology: https://510kreport.com/methodology