Product code PHX— Orthopedic
AEQUALIS REVERSED SHOULDER PROSTHESIS
- Classification name
- Shoulder Prosthesis, Reverse Configuration
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Total cleared
- 205
- First cleared
- Most recent
FDA classification definition
“Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.”
Market context for product code PHX
FDA has cleared devices under product code PHX between 2003 and 2026, filed by 43 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code PHX
Adverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PHX
1–100 of 205- K260556 — Veritas Shoulder System
- K261683 — Augment Off-Axis Instrument System
- K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
- K261016 — MSS - Humeral reverse liners extension
- K253992 — Veritas Reverse Total Shoulder System
- K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
- K260583 — Equinoxe® Shoulder System
- K254128 — InSet Reverse Total Shoulder System
- K253674 — Blueprint Patient-Specific Instrumentation
- K253624 — INHANCE Reverse Shoulder System
- K250644 — MSS - Monobloc stem
- K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
- K252516 — N22 EZ Glenosphere
- K252567 — AltiVate Reverse® ADLC Glenosphere
- K254003 — JARVIS Metaphyseal Stem
- K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)
- K250338 — MSS - Humeral reverse liners extension
- K253345 — JARVIS Diaphyseal Stem Standard
- K252221 — Inset Reverse Total Shoulder System
- K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis
- K252141 — AltiVate Reverse® Glenoid
- K243448 — Equinoxe® Shoulder System
- K243826 — SMR Reverse HP Shoulder System
- K243643 — restor3d Reverse Total Shoulder Arthroplasty System
- K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
- K242253 — JARVIS Glenoid Reverse Shoulder Prosthesis
- K241491 — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
- K233482 — Equinoxe® Central Screw Baseplate System
- K233481 — AltiVate Reverse® Glenoid
- K240278 — Full Wedge Lateralized and Augmented Baseplates
- K241043 — Augment Off-Axis Instrument System
- K234105 — Catalyst F1x Shoulder System
- K233148 — Augment Off-Axis Instrument System
- K232265 — BLUEPRINT Patient Specific Instrumentation
- K231445 — LINK Embrace Shoulder System - Reverse Configuration
- K231911 — Glenoid Reconstruction System Full Wedge Baseplate
- K232583 — Catalyst R1 Reverse Shoulder System
- K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
- K232226 — ARROW Off-Centred Humeral Insert
- K223801 — FX V135(TM) Shoulder Prosthesis
- K223655 — Catalyst R1 Reverse Shoulder System
- K230366 — Arthrex Univers Revers Monoblock Stem Size 4/33
- K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
- K223211 — INHANCETM Shoulder System Humeral Stems and Stemless
- K213459 — Glenoid Reconstruction System
- K222936 — Humeris® 135 Shoulder System
- K220914 — Tornier Perform Humeral System Fracture
- K221467 — INHANCETM Reverse Glenoid Peripheral Posts
- K213349 — Catalyst R1 Reverse Shoulder System
- K213117 — FX V135 Shoulder Prosthesis
- K212737 — INHANCE Reverse Shoulder System
- K212800 — PRIMA Humeral System and SMR Glenosphere Ø42
- K202024 — ARROW Short Stem Humeral System
- K212992 — LINK® Embrace Shoulder System - Reverse Configuration
- K212415 — Arthrex Modular Glenoid System-Titanium Glenosphere
- K211359 — Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation
- K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner
- K213124 — Tomier Perform Reversed Glenoid Cannulated Glenospheres
- K212710 — GLOBAL UNITE Platform Shoulder System
- K211074 — Univers Revers Modular Glenoid System, Standard Augment Baseplates
- K210790 — Lateralized and Augmented Baseplates
- K210533 — Inset Reverse Total Shoulder System
- K211553 — Tecomet Global Unite Short Stem Instrumentation
- K211991 — Catalyst R1 Reverse Shoulder System
- K203694 — DELTA XTEND Reverse Shoulder System
- K210717 — Bone Screws dia. 5,0 mm
- K203375 — OVOMotion Reverse Shoulder Arthroplasty System
- K210207 — Humeral Eccentric Reverse Metaphysis
- K203755 — Shoulder System - TiNbN Coating
- K202232 — Comprehensive Vault Reconstruction System
- K210167 — DELTA XTEND Reverse Shoulder System
- K202611 — Catalyst OrthoScience R1 Reverse Shoulder System
- K200368 — LINK Embrace Shoulder System - Reverse Configuration
- K202098 — GLOBAL UNITE Platform Shoulder System
- K200171 — SMR TT Augmented Glenoid System
- K200895 — Univers Revers Modular Glenoid System, Half Augment Baseplate
- K193175 — Lateralized Glenosphere
- K191146 — Humelock TiN Coated Glenosphere
- K193394 — Humeral Cup Stability & Humeral Cup 135/145o Stability
- K193373 — Comprehensive® Reverse Shoulder
- K192967 — Medacta Shoulder System
- K192855 — DELTA XTEND(TM) Reverse Shoulder System
- K192799 — Glenoid Baseplate with Screw
- K193098 — Exactech® Equinoxe® Reverse Shoulder Glenospheres
- K193099 — Anatomical Shoulder System
- K193372 — Univers Revers Modular Glenoid System (Augemented baseplates)
- K191960 — Arthrex Univers Revers Modular Glenoid System
- K190738 — MyShoulder Placement Guides
- K190588 — Integra TITAN Reverse Shoulder System
- K191746 — SMR TT Augmented Glenoid System
- K192206 — 32mm Glenosphere and Humeral Cup
- K192448 — Delta Xtend Revers Shoulder System
- K191561 — Exactech Equinoxe Humeral Augmented Trays
- K183077 — Delta Xtend Reverse Shoulder System
- K183696 — Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
- K181826 — Glenoid Polyaxial Non-locking Screws
- K181999 — Integra TITAN Reverse Shoulder System
- K182536 — Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
- K182039 — Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
- K181611 — Comprehensive Reverse Shoulder System
Data sourced from openFDA. This site is unofficial and independent of the FDA.