# K212737: INHANCE™ Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Apr 21, 2022 after 234 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 15 generations back to K911686 (1991). 183 ancestors in all.
9 later devices descend from it; 7 cite it directly.
1 of 193 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193373: Comprehensive® Reverse Shoulder, Biomet, Inc. (2020) Summary page 6.
- K202716: Ignite Anatomic Shoulder System, Ignite Orthopedics, LLC (2021) Summary page 6.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 6.

## Most influential descendants
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K241817: InSet Total Shoulder System (2025), 1 descendant of its own
- K262173: N22 Offset Humeral Head (2026), 0 descendants of its own
- K261016: MSS - Humeral reverse liners extension (2026), 0 descendants of its own
- K254128: InSet Reverse Total Shoulder System (2026), 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, where other methods of treatment are deemed inadequate (with Standard or Long Stems) * Difficult clinical management problems where other methods of treatment 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. Reverse Total Shoulder The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem. * A severely painful, disabling, arthritic joint * Fractures of the humeral head (with Short Humeral Stems) * Fractures of the proximal humerus (with Standard or Long Stems) * Revisions of previously failed shoulder joint replacements Fixation Methods The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Source page: https://510kreport.com/device/K212737
Methodology: https://510kreport.com/methodology