Tornier Perform Advanced Glenoid— 510(k) K260721
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K260721 for Tornier Perform Advanced Glenoid, Substantially Equivalent on 2026-07-22. Applicant: Tornier, Inc.. Device class: 2.
Summary
Tornier's Perform Advanced Glenoid is filed under KWS, semi-constrained metal/polymer cemented shoulder prostheses. The record doesn't give sizes or materials.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Tornier filed from Bloomington, Minnesota. Review took 139 calendar days (March 5 to July 22, 2026).
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Product code KWS
- 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 KWS
view allMore clearances from Tornier, Inc.
view allAdverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.