TOTAL TOE SYSTEM II
FDA 510(k) clearance K941650 · decided 1994-12-19
Clearance details
- K-number
- K941650
- Device name
- TOTAL TOE SYSTEM II
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-05
- Decision date
- 1994-12-19
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- LZJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |