ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
FDA 510(k) clearance K161668 · decided 2016-07-15
Clearance details
- K-number
- K161668
- Device name
- ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-16
- Decision date
- 2016-07-15
- Days to decision
- 29 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 ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee recall (Z-0991-2017) | ConforMIS, Inc. | 2017-01-10 |