# K212933: INHANCETM Hybrid Anatomic Glenoid Implant

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jun 8, 2022 after 266 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 160 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 162 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202716: Ignite Anatomic Shoulder System, Ignite Orthopedics, LLC (2021) Summary page 4.
- K060694: Modular Hybrid Glenoid, Biomet Manufacturing Corp (2006) Summary page 4.

## Most influential descendants
- K243248: Inhance Intact™ (2024), 0 descendants of its own

## Indications for use
Anatomic Total Shoulder or Hemi-Shoulder 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 The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis. * Revision where other devices or treatments have failed. * Correction of functional deformity. * Fractures of the humeral head (with Short Humeral Stems) * Fractures of the proximal humerus (with Standard or Long Stems) * Difficult clinical management problems where other methods oftreatment may not be suitable or may be inadequate. Fixation Methods The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Source page: https://510kreport.com/device/K212933
Methodology: https://510kreport.com/methodology