Panels › Orthopedic › Product code KWD · Class 2
Prosthesis, Toe, Hemi-, Phalangeal
Regulation 888.3730
1510(k)s in 12 months (46 all time)
1recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in KWD
| Company | 510(k)s | Recalls |
|---|---|---|
| Biopro, Inc. | 3 | 10 |
| Arthrosurface, Inc. | 5 | 0 |
| Solana Surgical, LLC | 4 | 0 |
| Orthopro, LLC | 2 | 1 |
| Osteomed LP | 3 | 0 |
| Vilex, Inc. | 3 | 0 |
| Accufix Surgical, Inc. | 2 | 0 |
| Ascension Orthopedics, Inc. | 2 | 0 |
| BioPoly, LLC | 2 | 0 |
| Restor3D, Inc. | 1 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2026 | K250074 | HYALEX® MTP Hemiarthroplasty Implant Hyalex Orthopaedics, Inc. | KWD |
| Feb 29, 2024 | K240268 | Accu-Joint Hemi Implant Accufix Surgical, Inc. | KWD |
| Apr 19, 2023 | K221220 | Montross Extremity Medical Hemi Implant System Montross Extremity Medical | KWD |
| Nov 22, 2022 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant BioPoly, LLC | KWD |
| May 25, 2022 | K201393 | restor3d MTP Implant Restor3D, Inc. | KWD |
| Feb 2, 2021 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant BioPoly, LLC | KWD |
| Dec 8, 2020 | K200951 | Accu-Joint Hemi Implant Accufix Surgical, Inc. | KWD |
| Aug 14, 2019 | K190261 | BOSS Toe Fixation System Arthrosurface, Inc. | KWD |
| May 31, 2019 | K190543 | Cannulated Hemi Implant Vilex IN Tennessee, Inc. | KWD |
| Feb 1, 2017 | K161279 | Life Spine Metatarsal Hemi Implant Life Spine, Inc. | KWD |
| Apr 11, 2016 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System Arthrosurface, Inc. | KWD |
| Nov 19, 2013 | K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT Arthrosurface, Inc. | KWD |
| Oct 22, 2013 | K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM Solana Surgical, LLC | KWD |
| Oct 30, 2012 | K121973 | BIOPRO HEMI-EDGE TOE SYSTEM Biopro, Inc. | KWD |
| Feb 6, 2012 | K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET Solana Surgical, LLC | KWD |
| Feb 6, 2012 | K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET Solana Surgical, LLC | KWD |
| Jul 20, 2011 | K102401 | HEMI IMPLANT; MINI HEMI IMPLANT Vilex, Inc. | KWD |
| Jan 14, 2010 | K092047 | ASCENSION METAL GREAT TOE SYSTEM Ascension Orthopedics, Inc. | KWD |
| May 1, 2009 | K090127 | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 Solana Surgical, LLC | KWD |
| Feb 13, 2009 | K083469 | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 Metasurg | KWD |
| Aug 1, 2008 | K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING Osteomed LP | KWD |
| Mar 19, 2008 | K073635 | SBI SR MTP TOE IMPLANT Small Bone Innovations, Inc. | KWD |
| Feb 21, 2008 | K073065 | OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM Osteomed LP | KWD |
| Nov 28, 2007 | K072922 | 3S HEMI TOE Trilliant Surgical, Ltd. | KWD |
| May 23, 2007 | K071243 | METAL HEMI IMPLANT Orthopro, LLC | KWD |
| Mar 28, 2007 | K070052 | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION Vilex, Inc. | KWD |
| Jan 12, 2007 | K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY Arthrosurface, Inc. | KWD |
| Jan 3, 2007 | K063058 | ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS Arthrex, Inc. | KWD |
| Nov 13, 2006 | K062908 | ORTHROPRO HEMI TOE Orthopro, LLC | KWD |
| Oct 3, 2006 | K062040 | SBI TRIHEDRON MTP HEMI GT Small Bone Innovations, Inc. | KWD |
| Jun 2, 2006 | K060536 | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM Osteomed LP | KWD |
| May 5, 2006 | K060560 | ASCENSION PYROSPHERE CMC/TMT Ascension Orthopedics, Inc. | KWD |
| Nov 12, 2004 | K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 Biopro, Inc. | KWD |
| Mar 1, 2004 | K023684 | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 Vilex, Inc. | KWD |
| Feb 18, 2004 | K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT Arthrosurface, Inc. | KWD |
| Nov 26, 2003 | K030319 | ORTHOSPHERE CERAMIC SPHERICAL IMPLANT Wrightmedicaltechnologyinc | KWD |
| Dec 12, 2002 | K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) Kinetikos Medical, Inc. | KWD |
| Jul 1, 2002 | K021063 | GREAT TOE IMPLANT Signal Medical Corp. | KWD |
| Mar 12, 2002 | K014164 | GREAT TOE IMPLANT SYSTEM Harmos Orthopaedics, Inc. | KWD |
| Feb 22, 2001 | K003629 | MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 Terray Corp., CA | KWD |
| Jun 20, 1997 | K971047 | FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT Nexa Orthopedics, Inc. | KWD |
| Nov 22, 1991 | K911378 | TOWNLEY GREAT TOE JOINT Biopro, Inc. | KWD |
| Feb 3, 1988 | K875249 | SUTTER PHALANGEAL CAP Sutter Biomedical, Inc. | KWD |
| Apr 15, 1987 | K864492 | SWANSON TITANIUM GREAT TOE IMPLANT Dow Corning Wright | KWD |
| Sep 8, 1986 | K861983 | SUTTER LESSER METATARSAL CAP Sutter Biomedical, Inc. | KWD |
| Feb 9, 1979 | K781870 | IMPLANT, H.P. CONDYLAR Dow Corning Corp. Healthcare Industries Materials | KWD |
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