# K243248: Inhance Intact™

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Dec 23, 2024 after 73 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: 16 generations back to K911686 (1991). 180 ancestors in all.
No later device cites it as a predicate yet.
1 of 181 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203108: Ignite Stemless Anatomic Shoulder System, Ignite Orthopedics, LLC (2021) Summary page 5.
- K212933: INHANCETM Hybrid Anatomic Glenoid Implant, Depuy Ireland UC (2022) Summary page 5.

## Indications for use
The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: » Osteoarthritis » Post-traumatic arthrosis » Focal avascular necrosis of the humeral head * Previous surgeries of the shoulder that do not compromise the fixation Fixation Methods: The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only. The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process and for storage.

Source page: https://510kreport.com/device/K243248
Methodology: https://510kreport.com/methodology