K201157 is an FDA 510(k) clearance for the Prime BIOFOAM® Multi-Hole Shells. This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous (Class II - Special Controls, product code MBL).
Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on August 24, 2021, 481 days after receiving the submission on April 30, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K201157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2020 |
| Decision Date | August 24, 2021 |
| Days to Decision | 481 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBL — Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |