Prosthesis, Toe, Hemi-, Phalangeal
FDA product code KWD · Class II (moderate risk) · 21 CFR 888.3730 · Orthopedic
46510(k) clearances
0PMA approvals
13recalls
Implantimplanted device
Manufacturers
- Arthrosurface, Inc. 5
- Solana Surgical, LLC 4
- Biopro, Inc. 3
- Osteomed LP 3
- Vilex, LLC 3
- Accufix Surgical, Inc. 2
- BioPoly, LLC 2
- Orthopro, LLC 2
- Small Bone Innovations, Inc. 2
- Ascension Orthopedics, Inc. 2
- Sutter Biomedical, Inc. 2
- Wrightmedicaltechnologyinc 1
- Kinetikos Medical, Inc. 1
- Signal Medical Corp. 1
- Harmos Orthopaedics, Inc. 1
- Terray Corp. 1
- Nexa Orthopedics, Inc. 1
- Hyalex Orthopaedics, Inc. 1
- Trilliant Surgical, Ltd. 1
- Dow Corning Wright 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty ImplantKWD · Traditional | Hyalex Orthopaedics, Inc. | 04/03/2026SE |
| K240268 | Accu-Joint Hemi ImplantKWD · Special | Accufix Surgical, Inc. | 02/29/2024SE |
| K221220 | Montross Extremity Medical Hemi Implant SystemKWD · Traditional | Montross Extremity Medical | 04/19/2023SE |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 11/22/2022SE |
| K201393 | restor3d MTP ImplantKWD · Traditional | Restor3D, Inc. | 05/25/2022SE |
| K203634 | BioPoly Great Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 02/02/2021SE |
| K200951 | Accu-Joint Hemi ImplantKWD · Traditional | Accufix Surgical, Inc. | 12/08/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | Arthrosurface, Inc. | 08/14/2019SE |
| K190543 | Cannulated Hemi ImplantKWD · Traditional | Vilex IN Tennessee, Inc. | 05/31/2019SE |
| K161279 | Life Spine Metatarsal Hemi ImplantKWD · Traditional | Life Spine, Inc. | 02/01/2017SE |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD · Special | Arthrosurface, Inc. | 04/11/2016SE |
| K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantKWD · Traditional | Arthrosurface, Inc. | 11/19/2013SE |
| K131187 | Lesser Metatarsal Head Implant SystemKWD · Traditional | Solana Surgical, LLC | 10/22/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | Biopro, Inc. | 10/30/2012SE |
| K120029 | Hemi Phalangeal Implant Surgical Instrument SetKWD · Traditional | Solana Surgical, LLC | 02/06/2012SE |
| K113752 | Metatarsal Decompression Implant Surgical Instrument SetKWD · Traditional | Solana Surgical, LLC | 02/06/2012SE |
| K102401 | Hemi Implant; Mini Hemi ImplantKWD · Traditional | Vilex, Inc. | 07/20/2011SE |
| K092047 | Ascension Metal Great Toe SystemKWD · Traditional | Ascension Orthopedics, Inc. | 01/14/2010SE |
| K090127 | Metatarsal Decompression Implant, Model 100KWD · Traditional | Solana Surgical, LLC | 05/01/2009SE |
| K083469 | Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000KWD · Traditional | Metasurg | 02/13/2009SE |
| K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingKWD · Special | Osteomed LP | 08/01/2008SE |
| K073635 | Sbi SR MTP Toe ImplantKWD · Traditional | Small Bone Innovations, Inc. | 03/19/2008SE |
| K073065 | Osteomed Metatarsal Resurfacing Implant SystemKWD · Traditional | Osteomed LP | 02/21/2008SE |
| K072922 | 3S Hemi ToeKWD · Traditional | Trilliant Surgical, Ltd. | 11/28/2007SE |
| K071243 | Metal Hemi ImplantKWD · Special | Orthopro, LLC | 05/23/2007SE |
| K070052 | Met-Head Model# Mhdd-Xx:Cc Diameter, CC CannulationKWD · Traditional | Vilex, Inc. | 03/28/2007SE |
| K063370 | Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyKWD · Traditional | Arthrosurface, Inc. | 01/12/2007SE |
| K063058 | Arthrex Anatoemic Phalangeal ProsthesisKWD · Traditional | Arthrex, Inc. | 01/03/2007SE |
| K062908 | Orthropro Hemi ToeKWD · Traditional | Orthopro, LLC | 11/13/2006SE |
| K062040 | Sbi Trihedron MTP Hemi GTKWD · Traditional | Small Bone Innovations, Inc. | 10/03/2006SE |
| K060536 | Osteomed 1ST MPJ Hemi Implant SystemKWD · Traditional | Osteomed LP | 06/02/2006SE |
| K060560 | Ascension Pyrosphere Cmc/TmtKWD · Traditional | Ascension Orthopedics, Inc. | 05/05/2006SE |
| K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870KWD · Traditional | Biopro, Inc. | 11/12/2004SE |
| K023684 | Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565…KWD · Traditional | Vilex, Inc. | 03/01/2004SE |
| K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantKWD · Traditional | Arthrosurface, Inc. | 02/18/2004SE |
| K030319 | Orthosphere Ceramic Spherical ImplantKWD · Abbreviated | Wrightmedicaltechnologyinc | 11/26/2003SE |
| K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)KWD · Special | Kinetikos Medical, Inc. | 12/12/2002SE |
| K021063 | Great Toe ImplantKWD · Traditional | Signal Medical Corp. | 07/01/2002SE |
| K014164 | Great Toe Implant SystemKWD · Traditional | Harmos Orthopaedics, Inc. | 03/12/2002SE |
| K003629 | MTP Resesurfacing JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03KWD · Traditional | Terray Corp. | 02/22/2001SE |
| K971047 | Futura Biomedical Metal Hemi Toe ImplantKWD · Traditional | Nexa Orthopedics, Inc. | 06/20/1997SE |
| K911378 | Townley Great Toe JointKWD · Traditional | Biopro, Inc. | 11/22/1991SE |
| K875249 | Sutter Phalangeal CapKWD · Traditional | Sutter Biomedical, Inc. | 02/03/1988SE |
| K864492 | Swanson Titanium Great Toe ImplantKWD · Traditional | Dow Corning Wright | 04/15/1987SE |
| K861983 | Sutter Lesser Metatarsal CapKWD · Traditional | Sutter Biomedical, Inc. | 09/08/1986SE |
| K781870 | Implant, H.P. CondylarKWD · Traditional | Dow Corning Corp. Healthcare Industries Materials | 02/09/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0691-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0690-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0689-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0688-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0687-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0686-2022 Class II | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0685-2022 Class II | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0684-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0683-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0682-2022 Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU… | BioPro, Inc. | 02/01/2022Terminated |
| Z-0562-2020 Class II | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104The firm discovered a lack of adequate documentation confirming sterility on certain products. | Wright Medical Technology, Inc. | 11/08/2016Terminated |
| Z-0813-2015 Class II | Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint…Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and… | Integra LifeSciences Corp. | 11/06/2014Terminated |
| Z-2228-2008 | Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03…Labeling presented conflicting information as to whether device was sterile or not. | OrthoPro LLC | 05/29/2008Terminated |