Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
FDA 510(k) clearance K241878 · decided 2024-12-06
Clearance details
- K-number
- K241878
- Device name
- Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
- Applicant
- Stryker Corporation (Tornier, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2024-06-28
- Decision date
- 2024-12-06
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- KWS
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tornier Perform Advanced Glenoid (K260721) | Tornier, Inc. | 2026-07-22 |
| AETOS Shoulder System - CONCELOC Glenoids (K254084) | Smith & Nephew, Inc. | 2026-04-06 |
| Catalyst F1x Shoulder System (K252418) | Catalyst Orthoscience, Inc. | 2025-11-06 |
| AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416) | Smith & Nephew, Inc. | 2025-10-29 |
| MyShoulder Planner (5.3SSWPL) (K241292) | Medacta International S.A. | 2025-01-30 |
| Tornier Humeral Reconstruction System (Tornier HRS) (K241609) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| Arthrex Univers Apex OptiFit Humeral Stem (K230513) | Arthrex, Inc. | 2023-09-26 |
| AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592) | Encore Medical L.P. | 2023-06-23 |
| AETOS Shoulder System (K230572) | Smith & Nephew, Inc. | 2023-06-07 |
| AETOS Shoulder System (K220847) | Smith & Nephew, Inc. | 2023-01-03 |
| Catalyst EA Convertible Stemmed Shoulder (K222317) | Catalyst Orthoscience, Inc. | 2022-11-10 |
| AltiVate® Anatomic Shoulder AG e+™ with Markers (K213387) | Encore Medical L.P. | 2022-07-07 |
Recalls involving this device
No recalls on record reference this clearance.