FDA Product Code
FDA Product Code KWD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3730
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | 2026-04-03 | Traditional | PDF ↗ |
| K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2024-02-29 | Special | PDF ↗ |
| K221220 | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | 2023-04-19 | Traditional | PDF ↗ |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022-11-22 | Traditional | PDF ↗ |
| K201393 | restor3d MTP Implant | Restor3D, Inc. | 2022-05-25 | Traditional | PDF ↗ |
| K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021-02-02 | Traditional | PDF ↗ |
| K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020-12-08 | Traditional | PDF ↗ |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | 2019-08-14 | Traditional | PDF ↗ |
| K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019-05-31 | Traditional | PDF ↗ |
| K161279 | Life Spine Metatarsal Hemi Implant | Life Spine, Inc. | 2017-02-01 | Traditional | PDF ↗ |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016-04-11 | Special | PDF ↗ |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | 2013-11-19 | Traditional | PDF ↗ |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | Solana Surgical, LLC | 2013-10-22 | Traditional | PDF ↗ |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | Biopro, Inc. | 2012-10-30 | Traditional | PDF ↗ |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 | Traditional | PDF ↗ |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 | Traditional | PDF ↗ |
| K102401 | HEMI IMPLANT; MINI HEMI IMPLANT | Vilex, Inc. | 2011-07-20 | Traditional | PDF ↗ |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Ascension Orthopedics, Inc. | 2010-01-14 | Traditional | PDF ↗ |
| K090127 | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | Solana Surgical, LLC | 2009-05-01 | Traditional | PDF ↗ |
| K083469 | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 | Metasurg | 2009-02-13 | Traditional | PDF ↗ |
| K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING | Osteomed LP | 2008-08-01 | Special | PDF ↗ |
| K073635 | SBI SR MTP TOE IMPLANT | Small Bone Innovations, Inc. | 2008-03-19 | Traditional | PDF ↗ |
| K073065 | OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM | Osteomed LP | 2008-02-21 | Traditional | PDF ↗ |
| K072922 | 3S HEMI TOE | Trilliant Surgical, Ltd. | 2007-11-28 | Traditional | PDF ↗ |
| K071243 | METAL HEMI IMPLANT | Orthopro, LLC | 2007-05-23 | Special | PDF ↗ |
| K070052 | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION | Vilex, Inc. | 2007-03-28 | Traditional | PDF ↗ |
| K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | Arthrosurface, Inc. | 2007-01-12 | Traditional | PDF ↗ |
| K063058 | ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS | Arthrex, Inc. | 2007-01-03 | Traditional | PDF ↗ |
| K062908 | ORTHROPRO HEMI TOE | Orthopro, LLC | 2006-11-13 | Traditional | PDF ↗ |
| K062040 | SBI TRIHEDRON MTP HEMI GT | Small Bone Innovations, Inc. | 2006-10-03 | Traditional | PDF ↗ |
| K060536 | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM | Osteomed LP | 2006-06-02 | Traditional | PDF ↗ |
| K060560 | ASCENSION PYROSPHERE CMC/TMT | Ascension Orthopedics, Inc. | 2006-05-05 | Traditional | PDF ↗ |
| K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | Biopro, Inc. | 2004-11-12 | Traditional | PDF ↗ |
| K023684 | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 | Vilex, Inc. | 2004-03-01 | Traditional | PDF ↗ |
| K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | 2004-02-18 | Traditional | PDF ↗ |
| K030319 | ORTHOSPHERE CERAMIC SPHERICAL IMPLANT | Wrightmedicaltechnologyinc | 2003-11-26 | Abbreviated | PDF ↗ |
| K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | Kinetikos Medical, Inc. | 2002-12-12 | Special | PDF ↗ |
| K021063 | GREAT TOE IMPLANT | Signal Medical Corp. | 2002-07-01 | Traditional | PDF ↗ |
| K014164 | GREAT TOE IMPLANT SYSTEM | Harmos Orthopaedics, Inc. | 2002-03-12 | Traditional | PDF ↗ |
| K003629 | MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 | Terray Corp. | 2001-02-22 | Traditional | PDF ↗ |
| K971047 | FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT | Nexa Orthopedics, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K911378 | TOWNLEY GREAT TOE JOINT | Biopro, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K875249 | SUTTER PHALANGEAL CAP | Sutter Biomedical, Inc. | 1988-02-03 | Traditional | PDF ↗ |
| K864492 | SWANSON TITANIUM GREAT TOE IMPLANT | Dow Corning Wright | 1987-04-15 | Traditional | PDF ↗ |
| K861983 | SUTTER LESSER METATARSAL CAP | Sutter Biomedical, Inc. | 1986-09-08 | Traditional | PDF ↗ |
| K781870 | IMPLANT, H.P. CONDYLAR | Dow Corning Corp. Healthcare Industries Materials | 1979-02-09 | Traditional | PDF ↗ |
Product code KWD · Class II · Orthopedic. Data: openFDA.