OFFSET TIBIAL TRAY
FDA 510(k) clearance K010212 · decided 2001-02-14
Clearance details
- K-number
- K010212
- Device name
- OFFSET TIBIAL TRAY
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-23
- Decision date
- 2001-02-14
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- MBV
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| TRICON-M TOTAL KNEE SYSTEM (K884824) | Richards Medical Co., Inc. | 1989-11-21 |
| FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE (K873429) | Protek, Inc. | 1987-10-28 |
| FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP (K853730) | Protek, Inc. | 1986-02-18 |
| TRICON M TOTAL KNEE SYSTEM (K833200) | Richards Medical Co., Inc. | 1983-11-29 |
| POROCOAT FREEMAN/SAMUELSON TOTAL KNEE (K831441) | Depuy, Inc. | 1983-09-01 |
| MARK I TOTAL KNEE SYS. ARTHROPLASTY (K832302) | Advanced Biosearch Assn. | 1983-08-16 |
| MARK I & II TOTAL KNEE REPLACE. SYS (K830726) | Advanced Biosearch Assn. | 1983-06-22 |
| RMC TOTAL KNEE SYSTEM (K823837) | Richard'S Medical Equip., Inc. | 1983-03-29 |
| FREEMAN/SAMUELSON TOTAL KNEE (K830408) | Depuy, Inc. | 1983-02-24 |
| TOTAL KNEE SYSTEM (K822583) | Richard'S Medical Equip., Inc. | 1982-10-04 |
| ICLH TIBIAL PLATEAU (K802921) | Depuy, Inc. | 1981-01-08 |
| KNEE, TOTAL, FEMORAL & TIBIAL (K780904) | Depuy, Inc. | 1978-06-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); I recall (Z-2177-2018) | Zimmer Biomet, Inc. | 2018-06-01 |
| Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee jo recall (Z-0533-2013) | Biomet, Inc. | 2012-12-17 |
| Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, recall (Z-1061-2009) | Biomet, Inc. | 2009-04-07 |
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 |