KWD — Prosthesis, Toe, Hemi-, Phalangeal Class II
FDA product code KWD covers "Prosthesis, Toe, Hemi-, Phalangeal", a Class II medical device regulated under 21 CFR 888.3730. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWD
- Device Class
- Class II
- Regulation Number
- 888.3730
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250074 | hyalex orthopaedics | HYALEX® MTP Hemiarthroplasty Implant | April 3, 2026 |
| K240268 | accufix surgical | Accu-Joint Hemi Implant | February 29, 2024 |
| K221220 | montross extremity medical | Montross Extremity Medical Hemi Implant System | April 19, 2023 |
| K222964 | biopoly | BioPoly Lesser Toe Hemiarthroplasty Implant | November 22, 2022 |
| K201393 | restor3d | restor3d MTP Implant | May 25, 2022 |
| K203634 | biopoly | BioPoly Great Toe Hemiarthroplasty Implant | February 2, 2021 |
| K200951 | accufix surgical | Accu-Joint Hemi Implant | December 8, 2020 |
| K190261 | arthrosurface | BOSS Toe Fixation System | August 14, 2019 |
| K190543 | vilex in tennessee | Cannulated Hemi Implant | May 31, 2019 |
| K161279 | life spine | Life Spine Metatarsal Hemi Implant | February 1, 2017 |
| K152454 | arthrosurface | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | April 11, 2016 |
| K131377 | arthrosurface | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | November 19, 2013 |
| K131187 | solana surgical | LESSER METATARSAL HEAD IMPLANT SYSTEM | October 22, 2013 |
| K121973 | biopro | BIOPRO HEMI-EDGE TOE SYSTEM | October 30, 2012 |
| K120029 | solana surgical | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | February 6, 2012 |
| K113752 | solana surgical | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | February 6, 2012 |
| K102401 | vilex | HEMI IMPLANT; MINI HEMI IMPLANT | July 20, 2011 |
| K092047 | ascension orthopedics | ASCENSION METAL GREAT TOE SYSTEM | January 14, 2010 |
| K090127 | solana surgical | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | May 1, 2009 |
| K083469 | metasurg | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 | February 13, 2009 |