BLUEPRINT Patient Specific Instrumentation
FDA 510(k) K143374 · Tornier S.A.S.
510(k) numberK143374
Submission
- Device name
- BLUEPRINT Patient Specific Instrumentation
- Applicant
- Tornier S.A.S.
Montbonnot-Saint-Martin, FR - Received
- November 25, 2014
- Decision date
- April 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232265 | BLUEPRINT Patient Specific InstrumentationPHX · Traditional | 02/21/2024SE |
| 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 |
Questions and answers
When was BLUEPRINT Patient Specific Instrumentation cleared by the FDA?
BLUEPRINT Patient Specific Instrumentation (K143374) received a 510(k) decision of Substantially Equivalent on April 8, 2015, 134 days after the submission was received.
What is the product code of K143374?
The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.