Blueprint Patient-Specific Instrumentation— 510(k) K253674

Substantially Equivalent

Stryker Corporation (Tornier, S.A.S.)

FDA 510(k) clearance K253674 for Blueprint Patient-Specific Instrumentation, Substantially Equivalent on 2026-04-03. Applicant: Stryker Corporation (Tornier, S.A.S.).

Clearance details

Applicant: Stryker Corporation (Tornier, S.A.S.)
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2025-11-21
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montbonnot-Saint-Martin, FR

Download summary PDF View on FDA.gov ↗

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.