510(k) K260102
K260102 is an FDA 510(k) premarket notification submitted by Stryker Corporation (Tornier, Inc.) for the device "Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System". The FDA issued a decision of Substantially Equivalent on June 12, 2026. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Stryker Corporation (Tornier, Inc.) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2026
- Date Received
- January 13, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoulder Prosthesis, Reverse Configuration
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type
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.