The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for 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).
| Device ID | K213827 |
| 510k Number | K213827 |
| Device Name: | 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) |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Smith & Nephew, Inc. 11101 Metric Blvd Austin, TX 78758 |
| Contact | Stephanie Rincones |
| Correspondent | Stephanie Rincones Smith & Nephew, Inc. 11101 Metric Blvd Austin, TX 78758 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWI |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-08 |
| Decision Date | 2022-03-11 |