510(k) K232426— Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts

Substantially Equivalent

Conformis, Inc.

Clearance details

Applicant: Conformis, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2023-08-11
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Billerica, MA, US

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.