K112438 is an FDA 510(k) clearance for the TITAN MODULAR TOTAL SHOULDER SYSTEM. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Ascension Orthopedic (Austin, US). The FDA issued a Cleared decision on April 11, 2012, 231 days after receiving the submission on August 24, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K112438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2011 |
| Decision Date | April 11, 2012 |
| Days to Decision | 231 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |