KWD · Prosthesis, Toe, Hemi-, Phalangeal
Orthopedic · 21 CFR 888.3730 · Class 2
Overview
| Product Code | KWD |
|---|---|
| Device Name | Prosthesis, Toe, Hemi-, Phalangeal |
| Regulation | 21 CFR 888.3730 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | Apr 3, 2026 | SESE |
| K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | Feb 29, 2024 | SESE |
| K221220 | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | Apr 19, 2023 | SESE |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | Nov 22, 2022 | SESE |
| K201393 | restor3d MTP Implant | Restor3D, Inc. | May 25, 2022 | SESE |
| K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | Feb 2, 2021 | SESE |
| K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | Dec 8, 2020 | SESE |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | Aug 14, 2019 | SESE |
| K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | May 31, 2019 | SESE |
| K161279 | Life Spine Metatarsal Hemi Implant | Life Spine, Inc. | Feb 1, 2017 | SESE |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | Apr 11, 2016 | SESE |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | Nov 19, 2013 | SESE |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | Solana Surgical, LLC | Oct 22, 2013 | SESE |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | Biopro, Inc. | Oct 30, 2012 | SESE |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | Feb 6, 2012 | SESE |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | Feb 6, 2012 | SESE |
| K102401 | HEMI IMPLANT; MINI HEMI IMPLANT | Vilex, Inc. | Jul 20, 2011 | SESE |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Ascension Orthopedics, Inc. | Jan 14, 2010 | SESE |
| K090127 | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | Solana Surgical, LLC | May 1, 2009 | SESE |
| K083469 | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 | Metasurg | Feb 13, 2009 | SESE |
Top Applicants
- Arthrosurface, Inc. — 5 clearances
- Solana Surgical, LLC — 4 clearances
- Biopro, Inc. — 3 clearances
- Osteomed LP — 3 clearances
- Vilex, Inc. — 3 clearances
