iTotal Posterior Stabilized (PS) Knee Replacement System
FDA 510(k) clearance K142404 · decided 2014-12-11
Clearance details
- K-number
- K142404
- Device name
- iTotal Posterior Stabilized (PS) Knee Replacement System
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-27
- Decision date
- 2014-12-11
- Days to decision
- 106 days
- Clearance type
- Special
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M recall (Z-0141-2016) | ConforMIS, Inc. | 2015-10-21 |
| ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KI recall (Z-0147-2016) | ConforMIS, Inc. | 2015-10-21 |