Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
FDA 510(k) clearance K211359 · decided 2021-11-12
Clearance details
- K-number
- K211359
- Device name
- Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
- Applicant
- Tornier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-03
- Decision date
- 2021-11-12
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bloomington, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for sh recall (Z-1738-2025) | Tornier S.A.S. | 2025-05-08 |
| Stryker Blueprint Software, Catalog #BPUE001. recall (Z-1883-2024) | Tornier S.A.S. | 2024-05-22 |