510(k) K241609
- Device
- Tornier Humeral Reconstruction System (Tornier HRS)
- Applicant
- Stryker Corporation (Tornier, Inc.)
- 510(k) number
- K241609
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-10
- Date received
- 2024-06-05
- Regulation
- 888.3660
- Classification name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jang Long
- Address
- 10801 Nesbitt Ave. S. Bloomington MN US 55437 55437
FDA Registration Numbers#
- 1221934
- 3013700547
- 3010314800
- 3007539489
- 1835831
- 3010331645
- 3015916578
- 3015806723
- 1836357
- 1828464
- 1526534
- 1818910
- 3002806603
- 2528981
- 1000517406
- 3009973844
- 3008337808
- 3008388276
- 1721676
- 1424263
- 3011015572
- 3006128100
- 3010039400
- 3004748528
- 9681465
- 3003477135
- 3004371426
- 9611390
- 3021566676
- 9616671
- 1836116
- 1833986
- 2249615
- 3002806470
- 3003403260
- 3014833750
- 9616680
- 1220246
- 3016090213
- 3033509898
- 1822565
- 3012552981
- 3006946276
- 1825034
- 1222928
- 3006721341
- 3010178296
- 1834379
- 3014262693
- 3007420745
- 3007740680
- 3016851379
- 3004513872
- 3000258338
- 3009141957
- 1038671
- 3007923096
- 1054811
- 3035366890
- 2028632
- 3005751028
- 1220477
- 3008556682
- 3008534770
- 1057425
- 3015516266
- 3000264985
- 3013561205
- 3014315560
- 3000931034
- 2245304
- 1526350
- 3005913274
- 3009941480
- 3009475821
- 3012818475
- 3015231789
- 1649518
- 3015542154
- 3012544635
Source Documents#
Other 510(k) Records For Product Code KWS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023-09-26 |
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2023-06-23 |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-07 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022-07-07 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | 2022-03-11 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021-12-10 |