K170288 is an FDA 510(k) clearance for the BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on June 15, 2017, 136 days after receiving the submission on January 30, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K170288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2017 |
| Decision Date | June 15, 2017 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |