ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER— 510(k) K052086

Name: FDA 510(k) clearance K052086
Creator: U.S. Food and Drug Administration
Published: 2005-08-31

Substantially Equivalent

Encore Medical, Inc.

FDA 510(k) clearance K052086 for ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER, Substantially Equivalent on 2005-08-31. Applicant: Encore Medical, Inc.. Device class: 2.

Clearance details

Applicant: Encore Medical, Inc.
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2005-08-02
Decision date: 2005-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

view all

K260556 — Veritas Shoulder System2026-07-01
K261683 — Augment Off-Axis Instrument System2026-06-16
K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
K261016 — MSS - Humeral reverse liners extension2026-06-10
K253992 — Veritas Reverse Total Shoulder System2026-05-07

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.