Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid— 510(k) K161742
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K161742 for Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Substantially Equivalent on 2016-11-15. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, MN, US
Recent devices under product code PHX
view allMore clearances from Tornier, Inc.
view allAdverse 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 →
Recalls naming K161742
K-number listed on FDA's recall record- Z-1237-2026 — TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
- Z-0113-2024 — stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- Z-1216-2022 — Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161742.
Data sourced from openFDA. This site is unofficial and independent of the FDA.