510(k) K111596
- Device
- TOTAL SHOULDER SYSTEM
- Applicant
- SHOULDER INNOVATIONS, LLC
- 510(k) number
- K111596
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-05
- Date received
- 2011-06-08
- Regulation
- 888.3660
- Classification name
- Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW RODENHOUSE
- Address
- 4670 Fulton St. E. Ada MI US 49301 49301
FDA Registration Numbers#
- 1834331
- 3019807891
- 3011061242
- 3010009693
- 1526534
- 3008337808
- 3017397663
- 3004513872
- 2032521
- 3012755988
- 2245304
- 1043534
- 3008658204
- 3008534770
- 3009546990
- 2528981
- 8010379
- 3016090213
- 1828464
- 3004154314
- 3003998208
- 3011189525
- 3003898228
- 3003477135
- 3004371426
- 9613350
- 1057425
- 8031020
- 8010177
- 1822565
- 3021566676
- 3004641308
- 3015806723
- 3014833750
- 3004153896
- 3006356043
- 3010041693
- 3008110533
- 3006801265
- 3010400367
- 1222928
- 3013176080
- 3015516266
- 3009153862
- 3006946276
- 3011683674
- 3003403260
- 3009116370
- 1054811
- 1827096
- 3007366790
- 3012319330
- 9680515
- 2249697
- 1721676
- 3009241418
- 3012818475
- 3013791180
- 1649518
- 3009141957
- 3008556682
- 1424263
- 3010386387
- 2028632
- 3006721341
- 3026771806
- 9617840
- 1643264
- 1064858
- 3009887475
- 3031914485
- 8010916
- 9616680
- 3005144609
- 3005061536
- 1818910
- 3038503932
- 3036756245
- 3009555447
Source Documents#
Other 510(k) Records For Product Code KWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | 2026-07-22 |
| 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 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| 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 |
Legacy Summary#
summary
FDA Review#
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