Cleared Traditional

K243817 - Scorpio Universal Dome Patella (FDA 510(k) Clearance)

Also includes:

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

K243817 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device

Feb 2025

Decision

56d

Days

Class 2

Risk

K243817 is an FDA 510(k) clearance for the Scorpio Universal Dome Patella. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).

Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on February 6, 2025, 56 days after receiving the submission on December 12, 2024.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K243817 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 12, 2024
Decision Date	February 06, 2025
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 888.3560