K221675 is an FDA 510(k) clearance for the United U2 femoral head, 22mm delta ceramic head. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on November 4, 2022, 148 days after receiving the submission on June 9, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K221675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 148 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |