LZJ
11 FDA 510(k) clearances · Product code
201 daysmedian time to decision
471 days90th percentile
11clearances measured
FDA profile
- Official device name
- Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
- Device class
- Unclassified
- Medical specialty
- Unknown
- Flags
- Implant
- Adverse events (MAUDE)
- 2004: 6 · 2005: 3 · 2006: 3 · 2007: 3 · 2008: 4 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ARTHROSURFACE TOEMOTION (K132496) | Arthrosurface, Inc. | 2014-02-26 |
| THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (K102549) | Ascension Orthopedics, Inc. | 2010-12-21 |
| MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (K072251) | Merete Medical GmbH | 2008-05-08 |
| GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (K950864) | Acu Med, Inc. | 1995-07-31 |
| TOTAL TOE SYSTEM II (K941650) | Biomet, Inc. | 1994-12-19 |
| KINETIK GREAT TOE SYSTEM (K924724) | Kinetikos Medical, Inc. | 1994-01-05 |
| OSTEOMED GREAT TOE SYSTEM (K922211) | Osteomed Corp. | 1993-11-09 |
| TOTAL TOE SYSTEM (K920446) | Biomet, Inc. | 1993-03-22 |
| GREAT TOE IMPLANT (K920667) | Acu Med, Inc. | 1992-06-19 |
| ANATOMIC TOE SYSTEM (K911552) | Orthopaedic Biosystems | 1991-06-28 |
| KOENIG TOTAL TOE IMPLANT (K884561) | Dow Corning Wright | 1989-01-24 |
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Every clearance here is in the API, with alerts when new ones post.