K152454 is an FDA 510(k) clearance for the HemiCAP MTP Resurfacing Hemi-Arthroplasty System. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on April 11, 2016, 227 days after receiving the submission on August 28, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K152454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2015 |
| Decision Date | April 11, 2016 |
| Days to Decision | 227 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD - Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |