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.
Cleared Devices (46)
| 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 |
| K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING | Osteomed LP | Aug 1, 2008 | SESE |
| K073635 | SBI SR MTP TOE IMPLANT | Small Bone Innovations, Inc. | Mar 19, 2008 | SESE |
| K073065 | OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM | Osteomed LP | Feb 21, 2008 | SESE |
| K072922 | 3S HEMI TOE | Trilliant Surgical, Ltd. | Nov 28, 2007 | SESE |
| K071243 | METAL HEMI IMPLANT | Orthopro, LLC | May 23, 2007 | SESE |
| K070052 | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION | Vilex, Inc. | Mar 28, 2007 | SESE |
| K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | Arthrosurface, Inc. | Jan 12, 2007 | SESE |
| K063058 | ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS | Arthrex, Inc. | Jan 3, 2007 | SESE |
| K062908 | ORTHROPRO HEMI TOE | Orthopro, LLC | Nov 13, 2006 | SESE |
| K062040 | SBI TRIHEDRON MTP HEMI GT | Small Bone Innovations, Inc. | Oct 3, 2006 | SESE |
| K060536 | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM | Osteomed LP | Jun 2, 2006 | SESE |
| K060560 | ASCENSION PYROSPHERE CMC/TMT | Ascension Orthopedics, Inc. | May 5, 2006 | SESE |
| K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | Biopro, Inc. | Nov 12, 2004 | SESE |
| K023684 | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 | Vilex, Inc. | Mar 1, 2004 | SESE |
| K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | Feb 18, 2004 | SESE |
| K030319 | ORTHOSPHERE CERAMIC SPHERICAL IMPLANT | Wrightmedicaltechnologyinc | Nov 26, 2003 | SESE |
| K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | Kinetikos Medical, Inc. | Dec 12, 2002 | SESE |
| K021063 | GREAT TOE IMPLANT | Signal Medical Corp. | Jul 1, 2002 | SESE |
| K014164 | GREAT TOE IMPLANT SYSTEM | Harmos Orthopaedics, Inc. | Mar 12, 2002 | SESE |
| K003629 | MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 | Terray Corp. | Feb 22, 2001 | SESE |
| K971047 | FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT | Nexa Orthopedics, Inc. | Jun 20, 1997 | SESE |
| K911378 | TOWNLEY GREAT TOE JOINT | Biopro, Inc. | Nov 22, 1991 | SESE |
| K875249 | SUTTER PHALANGEAL CAP | Sutter Biomedical, Inc. | Feb 3, 1988 | SESE |
| K864492 | SWANSON TITANIUM GREAT TOE IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |
| K861983 | SUTTER LESSER METATARSAL CAP | Sutter Biomedical, Inc. | Sep 8, 1986 | SESE |
| K781870 | IMPLANT, H.P. CONDYLAR | Dow Corning Corp. Healthcare Industries Materials | Feb 9, 1979 | SESE |
Top Applicants
- Arthrosurface, Inc. — 5 clearances
- Solana Surgical, LLC — 4 clearances
- Vilex, Inc. — 3 clearances
- Osteomed LP — 3 clearances
- Biopro, Inc. — 3 clearances
