Blueprint Patient-Specific Instrumentation— 510(k) K253674
Substantially EquivalentStryker 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.). Device class: 2.
Summary
Blueprint Patient-Specific Instrumentation comes from Stryker Corporation (Tornier, S.A.S.), as the record lists the applicant, and is filed under product code PHX (Shoulder Prosthesis, Reverse Configuration). The record doesn't describe the instrumentation beyond its name and that code name.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Stryker filed from Montbonnot-Saint-Martin, France. The record shows 133 calendar days from receipt to decision (November 21, 2025 to April 3, 2026).
Clearance details
- Applicant
- Stryker Corporation (Tornier, S.A.S.)
- 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
- Montbonnot-Saint-Martin, FR
Recent devices under product code PHX
view allMore clearances from Stryker Corporation (Tornier, S.A.S.)
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.