K243817

Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert

510(k) number

K243817

Device name

Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert

Applicant

Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US

Product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai

Decision date

2025-02-06

Date received

2024-12-12

Decision

Substantially Equivalent

Clearance type

Traditional

Advisory committee

Orthopedic