510(k) K213827
- Device
- 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)
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K213827
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-11
- Date received
- 2021-12-08
- 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
- Stephanie Rincones
- Address
- 11101 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3014262693
- 3031914485
- 9616680
- 3020967480
- 3006128100
- 2029275
- 8010379
- 3000258338
- 3006721341
- 3006563559
- 3013561205
- 2528981
- 3003898228
- 2244478
- 1526350
- 1835444
- 1423662
- 3021008900
- 3007740680
- 3010537287
- 3009973844
- 9615674
- 1836116
- 3013700547
- 3016851379
- 8010177
- 3010287737
- 3019269298
- 3012544635
- 1422572
- 3033509898
- 3010400367
- 3008110533
- 3006984710
- 3014004349
- 3007993775
- 3002907620
- 2032521
- 3026771806
- 3010331645
- 3012755988
- 3011061242
- 3004371426
- 3014207283
- 2249697
- 3021566676
- 3008868758
- 3014315560
- 2028632
- 2245304
- 1644408
- 3008337808
- 3012470322
- 1018470
- 1064858
- 3008556682
- 9617083
- 9616671
- 8043792
- 3014680795
- 1057425
- 1818910
- 1836357
- 3000264985
- 3014833750
- 3009475821
- 3005913274
- 1220477
- 3005061536
- 3009888740
- 3015231789
- 3005144609
- 3010041693
- 3003998208
- 3008021110
- 3010047402
- 9616944
- 3005180920
- 3010375065
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 |
| 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 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021-12-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases