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K243817Substantially Equivalent

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

Howmedica Osteonics Corp., dba Stryker Orthopaedics, Mahwah NJ / Traditional, Substantially Equivalent

K243817 is the FDA 510(k) clearance record for 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, a class II device, cleared for Howmedica Osteonics Corp., Dba Stryker Orthopaedics on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 33 510(k) clearances for Howmedica Osteonics Corp., Dba Stryker Orthopaedics, from to . As of , FDA records show no recalls naming K243817.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JWH

Trailing 12 months
14 clearances under product code JWH in the twelve months to October 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260