# K262955: OsseoFit Stemless Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Sep 24, 2026 after 31 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: 9 generations back to K911686 (1991). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241873: OsseoFit Stemless Shoulder System, Zimmer, Inc. (2024) Summary page 5.

## Indications for use
Anatomic Total Shoulder Applications: • Osteoarthritis • The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants. OsseoFit® Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement. Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Source page: https://510kreport.com/device/K262955
Methodology: https://510kreport.com/methodology