Product code LZJ
- Device name
- Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
- Medical specialty
- Unknown
- Device class
- U
- 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 |
|---|---|---|---|
| K132496 | ARTHROSURFACE TOEMOTION | Arthrosurface, Inc. | 2014-02-26 |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | Ascension Orthopedics, Inc. | 2010-12-21 |
| K072251 | MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM | Merete Medical GmbH | 2008-05-08 |
| K950864 | GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) | Acu Med, Inc. | 1995-07-31 |
| K941650 | TOTAL TOE SYSTEM II | Biomet, Inc. | 1994-12-19 |
| K924724 | KINETIK GREAT TOE SYSTEM | Kinetikos Medical, Inc. | 1994-01-05 |
| K922211 | OSTEOMED GREAT TOE SYSTEM | Osteomed Corp. | 1993-11-09 |
| K920446 | TOTAL TOE SYSTEM | Biomet, Inc. | 1993-03-22 |
| K920667 | GREAT TOE IMPLANT | Acu Med, Inc. | 1992-06-19 |
| K911552 | ANATOMIC TOE SYSTEM | Orthopaedic Biosystems | 1991-06-28 |
| K884561 | KOENIG TOTAL TOE IMPLANT | Dow Corning Wright | 1989-01-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556828311 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556828281 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556828250 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556828229 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556828472 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556828441 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556828410 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556828502 | Movement Great Toe System | Smith & Nephew, Inc. | 2022-12-21 |
| 10381780065401 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065395 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065487 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065470 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065463 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065456 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065449 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065432 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065425 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065418 | KGTI™ Kinetik Great Toe Implant System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780234999 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236863 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236894 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236924 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236955 | Movement® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780257264 | KGTI™ | Ascension Orthopedics, Inc. | 2016-07-25 |
| M5289P0710020 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| 04048266000941 | ToeMobile™ Great Toe Endoprosthesis | Merete GmbH | 2015-10-15 |
| 04048266000958 | ToeMobile™ Great Toe Endoprosthesis | Merete GmbH | 2015-10-15 |
| 04048266000965 | ToeMobile™ Great Toe Endoprosthesis | Merete GmbH | 2015-10-15 |
| 04048266000972 | ToeMobile™ Great Toe Endoprosthesis | Merete GmbH | 2015-10-15 |
| 04048266047229 | ToeMobile™ Phalangeal Implant | Merete GmbH | 2015-10-15 |