K192024 is an FDA 510(k) clearance for the Cemented TSI Hip Stem. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II - Special Controls, product code LZO).
Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on June 19, 2020, 326 days after receiving the submission on July 29, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K192024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2019 |
| Decision Date | June 19, 2020 |
| Days to Decision | 326 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |