HYALEX® MTP Hemiarthroplasty Implant
Device Facts
| Record ID | K250074 |
|---|---|
| Device Name | HYALEX® MTP Hemiarthroplasty Implant |
| Applicant | Hyalex Orthopaedics, Inc. |
| Product Code | KWD · Orthopedic |
| Decision Date | Apr 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.
