# K182516: Comprehensive Nano Stemless Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Apr 22, 2019 after 221 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: 7 generations back to K911686 (1991). 61 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 68 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.
- K171858: Sidus Stem-Free Shoulder, Zimmer GmbH (2017) Summary page 4.
- K173388: Exactech Equinoxe Stemless Shoulder, Exactech, Inc. (2018) Summary page 4.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 4.

## Most influential descendants
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K241873: OsseoFit Stemless Shoulder System (2024), 1 descendant of its own
- K262955: OsseoFit Stemless Shoulder System (2026), 0 descendants of its own
- K243248: Inhance Intact™ (2024), 0 descendants of its own
- K230831: INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (2023), 0 descendants of its own

## Indications for use
1. Primary total shoulder arthroplasty. 2. Non-inflammatory degenerative joint disease including osteoarthritis Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications. The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.

Source page: https://510kreport.com/device/K182516
Methodology: https://510kreport.com/methodology