Blueprint Patient-Specific Instrumentation
FDA 510(k) clearance K253674 · decided 2026-04-03
Clearance details
- K-number
- K253674
- Device name
- Blueprint Patient-Specific Instrumentation
- Applicant
- Stryker Corporation (Tornier, S.A.S.)
- Decision
- Substantially Equivalent
- Date received
- 2025-11-21
- Decision date
- 2026-04-03
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montbonnot-Saint-Martin, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Veritas Shoulder System (K260556) | Restor3D | 2026-07-01 |
| Augment Off-Axis Instrument System (K261683) | Zimmer, Inc. | 2026-06-16 |
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| MSS - Humeral reverse liners extension (K261016) | Medacta International, SA | 2026-06-10 |
| Veritas Reverse Total Shoulder System (K253992) | Restor3D | 2026-05-07 |
| Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (K252404) | Biomet Orthopedics | 2026-04-15 |
| Equinoxe® Shoulder System (K260583) | Exactech, Inc. | 2026-04-14 |
| InSet Reverse Total Shoulder System (K254128) | Shoulder Innovations, Inc. | 2026-04-13 |
| INHANCE™ Reverse Shoulder System (K253624) | Depuy Ireland UC | 2026-03-11 |
| MSS - Monobloc stem (K250644) | Medacta International S.A. | 2026-02-03 |
| SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (K252352) | Lima Corporate S.P.A. | 2026-01-22 |
| AltiVate Reverse® ADLC Glenosphere (K252567) | Encore Medical L.P. | 2026-01-15 |
Recalls involving this device
No recalls on record reference this clearance.