iTotal® Hip Replacement System— 510(k) K162719

Substantially Equivalent

Conformis, Inc.

FDA 510(k) clearance K162719 for iTotal® Hip Replacement System, Substantially Equivalent on 2017-06-14. Applicant: Conformis, Inc..

Clearance details

Applicant: Conformis, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2016-09-29
Decision date: 2017-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.