BLUEPRINT Patient Specific Instrumentation
FDA 510(k) K232265 · Tornier S.A.S.
510(k) numberK232265
Submission
- Device name
- BLUEPRINT Patient Specific Instrumentation
- Applicant
- Tornier S.A.S.
Montbonnot-Saint-Martin, FR - Received
- July 31, 2023
- Decision date
- February 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
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.
Other 510(k)s with product code PHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | Restor3D | 07/01/2026SE |
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | Zimmer, Inc. | 06/16/2026SE |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional | Stryker Corporation (Tornier, Inc.) | 06/12/2026SE |
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International, SA | 06/10/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | Restor3D | 05/07/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | Biomet Orthopedics | 04/15/2026SE |
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 04/14/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 04/13/2026SE |
| K253674 | Blueprint Patient-Specific InstrumentationPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 04/03/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 03/11/2026SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K222510 | Blueprint Mixed Reality systemOLO · Traditional | 01/20/2023SE |
| K203315 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 04/15/2021SE |
| K190521 | Aequalis Ascend Flex Shoulder SystemKWS · Special | 06/12/2019SE |
| K162800 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 02/22/2017SE |
| K161789 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 12/27/2016SE |
| K153452 | Salto XT, Salto TalarisHSN · Traditional | 08/11/2016SE |
| K160555 | BLUEPRINT Patient Specific InstrumentationKWS · Special | 06/10/2016SE |
| K152966 | Aequalis Fx2PHX · Special | 01/14/2016SE |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS · Special | 09/24/2015SE |
| K143374 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 04/08/2015SE |
Questions and answers
When was BLUEPRINT Patient Specific Instrumentation cleared by the FDA?
BLUEPRINT Patient Specific Instrumentation (K232265) received a 510(k) decision of Substantially Equivalent on February 21, 2024, 205 days after the submission was received.
What is the product code of K232265?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.