Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record 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. · decided 2022-03-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Titan Reverse Shoulder System | LNR-0960-191-9S | Smith & Nephew, Inc. | PHX | 00885556864135 |
| Titan Modular Shoulder System 2.5 | MHH-0923-010-4216E | Smith & Nephew, Inc. | HSD KWS | 00885556861189 |
| Titan Modular Shoulder System 2.5 | BOD-0923-020-10LRG | Smith & Nephew, Inc. | HSD KWS | 00885556859407 |
| Titan Modular Shoulder System 2.5 | STEM-0920-025-06 | Smith & Nephew, Inc. | HSD KWS | 00885556862049 |
| Titan Humeral Resurfacing Arthroplasty | HRA-900-56/21-WW | Smith & Nephew, Inc. | HSD | 00885556837276 |
| Titan Reverse Shoulder System | LNR-0960-00R | Smith & Nephew, Inc. | KWS PHX | 00885556864029 |
| Titan Modular Shoulder System 2.5 | MHH-0923-010-4620E | Smith & Nephew, Inc. | HSD KWS | 00885556861288 |
| Titan Modular Shoulder System 2.5 | BSW-0920-021-01 | Smith & Nephew, Inc. | HSD KWS | 00885556859537 |
| Modular Radial Head (MRH) System | MRH-350-24L-WW | Smith & Nephew, Inc. | KWI | 00885556857434 |
| Titan Modular Shoulder System 2.5 | STEM-0920-025-07 | Smith & Nephew, Inc. | HSD KWS | 00885556862056 |
| Titan Modular Shoulder System 2.5 | GLN-0920-030-00K | Smith & Nephew, Inc. | HSD KWS | 00885556860342 |
| Titan Reverse Shoulder System | GLS-0961-05E-S | Smith & Nephew, Inc. | PHX | 00885556863824 |
| Titan Reverse Shoulder System | BBS-0960-21STD | Smith & Nephew, Inc. | KWS PHX | 00885556863480 |
| Titan Modular Shoulder System 2.5 | GLN-0920-030-00P | Smith & Nephew, Inc. | HSD KWS | 00885556860359 |
| Katalyst Biopolar Radial Head System | 221800 | Smith & Nephew, Inc. | KWI | 00885556827352 |
| Titan Reverse Shoulder System | GLS-0960-05E | Smith & Nephew, Inc. | KWS PHX | 00885556863787 |
| Titan Modular Shoulder System 2.5 | BOD-0923-020-14STD | Smith & Nephew, Inc. | HSD KWS | 00885556859469 |
| Titan Modular Shoulder System 2.5 | STEM-0920-025-08 | Smith & Nephew, Inc. | HSD KWS | 00885556862063 |
| Titan Reverse Shoulder System | SCW-0960-055-25 | Smith & Nephew, Inc. | KWS PHX | 00885556864357 |
| Titan Reverse Shoulder System | BBS-0960-21SML | Smith & Nephew, Inc. | KWS PHX | 00885556863473 |
| Titan Modular Shoulder System 2.5 | GLN-0920-030-02K | Smith & Nephew, Inc. | HSD KWS | 00885556860380 |
| Titan Humeral Resurfacing Arthroplasty | HRA-900-44/15-WW | Smith & Nephew, Inc. | HSD | 00885556837214 |
| Titan Modular Shoulder System 2.5 | MHH-0923-010-4419C | Smith & Nephew, Inc. | HSD KWS | 00885556861219 |
| Titan Reverse Shoulder System | LNR-0960-192-0R | Smith & Nephew, Inc. | PHX | 00885556864142 |
| Titan Reverse Shoulder System | LNR-0960-09R | Smith & Nephew, Inc. | KWS PHX | 00885556864081 |