510(k) K243192— iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

Substantially Equivalent

Nextstep Arthopedix, LLC

Clearance details

Applicant: Nextstep Arthopedix, LLC
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2024-09-30
Decision date: 2026-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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.