Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System— 510(k) K260102
Substantially EquivalentStryker Corporation (Tornier, Inc.)
FDA 510(k) clearance K260102 for Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System, Substantially Equivalent on 2026-06-12. Applicant: Stryker Corporation (Tornier, Inc.). Device class: 2.
Summary
This clearance from Stryker Corporation (Tornier, Inc.) names the Tornier Perform Reversed Glenoid and the Tornier Perform Reversed Augmented Glenoid Shoulder System. It's filed under PHX, reverse-configuration shoulder prostheses, and the record doesn't list components.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Stryker filed from Bloomington, Minnesota. Review took 150 calendar days (January 13 to June 12, 2026).
Clearance details
- Applicant
- Stryker Corporation (Tornier, Inc.)
- Product code
- Product 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 Stryker Corporation (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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.