Product code KWD
- Device name
- Prosthesis, Toe, Hemi-, Phalangeal
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3730
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | 2026-04-03 |
| K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2024-02-29 |
| K221220 | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | 2023-04-19 |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022-11-22 |
| K201393 | restor3d MTP Implant | Restor3D, Inc. | 2022-05-25 |
| K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021-02-02 |
| K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020-12-08 |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | 2019-08-14 |
| K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019-05-31 |
| K161279 | Life Spine Metatarsal Hemi Implant | Life Spine, Inc. | 2017-02-01 |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016-04-11 |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | 2013-11-19 |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | Solana Surgical, LLC | 2013-10-22 |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | Biopro, Inc. | 2012-10-30 |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-02-06 |
| K102401 | HEMI IMPLANT; MINI HEMI IMPLANT | Vilex, Inc. | 2011-07-20 |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Ascension Orthopedics, Inc. | 2010-01-14 |
| K090127 | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | Solana Surgical, LLC | 2009-05-01 |
| K083469 | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 | Metasurg | 2009-02-13 |
| K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING | Osteomed LP | 2008-08-01 |
| K073635 | SBI SR MTP TOE IMPLANT | Small Bone Innovations, Inc. | 2008-03-19 |
| K073065 | OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM | Osteomed LP | 2008-02-21 |
| K072922 | 3S HEMI TOE | Trilliant Surgical, Ltd. | 2007-11-28 |
| K071243 | METAL HEMI IMPLANT | Orthopro, LLC | 2007-05-23 |
| K070052 | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION | Vilex, Inc. | 2007-03-28 |
| K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | Arthrosurface, Inc. | 2007-01-12 |
| K063058 | ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS | Arthrex, Inc. | 2007-01-03 |
| K062908 | ORTHROPRO HEMI TOE | Orthopro, LLC | 2006-11-13 |
| K062040 | SBI TRIHEDRON MTP HEMI GT | Small Bone Innovations, Inc. | 2006-10-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810005668095 | Trigon | NVISION BIOMEDICAL TECHNOLOGIES, INC. | 2026-04-24 |
| 00810005668101 | Trigon | NVISION BIOMEDICAL TECHNOLOGIES, INC. | 2026-04-24 |
| 00810005668118 | Trigon | NVISION BIOMEDICAL TECHNOLOGIES, INC. | 2026-04-24 |
| 00810005668187 | Trigon | NVISION BIOMEDICAL TECHNOLOGIES, INC. | 2026-04-24 |
| 00810135963565 | Trigon | NVISION BIOMEDICAL TECHNOLOGIES, INC. | 2026-04-24 |
| 00810135963572 | Trigon | NVISION BIOMEDICAL TECHNOLOGIES, INC. | 2026-04-24 |
| 00885556830765 | PyroSphere CMC | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556830772 | PyroSphere CMC | Smith & Nephew, Inc. | 2022-12-22 |
| 10381780279471 | K2™ Hemi Toe Implant System | INTEGRA LIFESCIENCES CORPORATION | 2018-04-10 |
| 00841731121820 | Vilex Drill Cannulated | VILEX LLC | 2018-03-22 |
| 10381780065548 | Integra® Miltex® | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 10381780074274 | Integra® BioMotion® Cannulated Hemi System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065579 | K2™ Hemi Toe Implant System | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 10381780065562 | K2™ Hemi Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065555 | Integra® Miltex® | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 00889797027014 | METAL HEMI | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00889797027021 | METAL HEMI | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 00889797027038 | METAL HEMI | WRIGHT MEDICAL TECHNOLOGY, INC. | 2016-09-17 |
| 10381780237150 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780237143 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236948 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236931 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236917 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236900 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236887 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236870 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236856 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236849 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780234999 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780257240 | K2™ | Ascension Orthopedics, Inc. | 2016-07-25 |