IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
FDA 510(k) clearance K093513 · decided 2009-12-16
Clearance details
- K-number
- K093513
- Device name
- IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-13
- Decision date
- 2009-12-16
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- NPJ
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Burlington, MA, 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 |
|---|---|---|
| RESTORIS Multicompartmental Knee System (K150307) | Mako Surgical Corp. | 2015-03-10 |
| RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (K133039) | Mako Surgical Corporation | 2013-12-10 |
| SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (K093056) | Smith & Nephew, Inc. | 2009-12-15 |
| RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (K090763) | Mako Surgical Corporation | 2009-06-17 |
| DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (K070849) | DePuy Orthopaedics, Inc. | 2007-06-26 |
| DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (K061648) | DePuy Orthopaedics, Inc. | 2006-09-11 |
| SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569) | Smith & Nephew, Inc. | 2006-07-06 |
| CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488) | Conformis, Inc. | 2006-03-09 |
| SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (K052265) | Smith & Nephew, Inc. | 2005-12-27 |
| STRYKER COMPARTMENTAL KNEE SYSTEM (K052917) | Howmedica Osteonics Corp. | 2005-12-27 |
| SMITH & NEPHEW HYBRID KNEE FEMORAL (K042896) | Smith & Nephew, Inc. | 2005-01-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Numbe recall (Z-0142-2016) | ConforMIS, Inc. | 2015-10-21 |
| ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalo recall (Z-0143-2016) | ConforMIS, Inc. | 2015-10-21 |
| ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS recall (Z-0148-2016) | ConforMIS, Inc. | 2015-10-21 |