# K253624: INHANCE™ Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Mar 11, 2026 after 113 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: 16 generations back to K911686 (1991). 190 ancestors in all.
No later device cites it as a predicate yet.
1 of 191 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212737: INHANCE™ Reverse Shoulder System, Depuy Ireland UC (2022) Summary page 7.
- K192855: DELTA XTEND (TM) Reverse Shoulder System, Depuy (Ireland) (2020)
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013)

## 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 humeral head and proximal humerus, where other methods of treatments 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 stem is intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only. The baseplate components of the convertible glenoids are intended for cementless application with the addition of screw fixation. When a convertible glenoid liner is used, the baseplate is indicated for use with a central screw and three peripheral locking screws that are 25mm or greater in length. The peripheral non-locking screws, peripheral posts and central posts are not indicated for use with the convertible glenoid. 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 humeral head and proximal humerus (with Standard or Long Stems) • Revision of previously failed shoulder joint replacement 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. When a Peripheral Post is used, the baseplate is indicated for use with a Central Screw and two Peripheral Locking Screws that are 25mm or greater in length. The peripheral Non-Locking screws and Central Post are not indicated for use with the Peripheral Post.

Source page: https://510kreport.com/device/K253624
Methodology: https://510kreport.com/methodology