K170072 is an FDA 510(k) clearance for the Fitmore® Hip Stem. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on February 7, 2017, 29 days after receiving the submission on January 9, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K170072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2017 |
| Decision Date | February 07, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |