Tomier Perform Reversed Glenoid Cannulated Glenospheres— 510(k) K213124

Name: FDA 510(k) clearance K213124
Creator: U.S. Food and Drug Administration
Published: 2021-10-26

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K213124 for Tomier Perform Reversed Glenoid Cannulated Glenospheres, Substantially Equivalent on 2021-10-26. Applicant: Tornier, Inc.. Device class: 2.

Clearance details

Applicant: Tornier, Inc.
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2021-09-27
Decision date: 2021-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, MN, 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

More clearances from Tornier, Inc.

view all

K260721 — Tornier Perform Advanced Glenoid2026-07-22
K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)2026-01-08
K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail2023-10-31
K220914 — Tornier Perform Humeral System Fracture2022-10-14

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.