ULTIMA SIZE 0 CEMENTED FEMORAL STEM— 510(k) K953200

Substantially Equivalent for Some Indications

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K953200 for ULTIMA SIZE 0 CEMENTED FEMORAL STEM, Substantially Equivalent for Some Indications on 1996-01-31. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1995-07-10
Decision date: 1996-01-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.