ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)— 510(k) K161668

Substantially Equivalent

Conformis, Inc.

FDA 510(k) clearance K161668 for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS), Substantially Equivalent on 2016-07-15. Applicant: Conformis, Inc..

Clearance details

Applicant: Conformis, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2016-06-16
Decision date: 2016-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.