Artisan Bone Plug, Universal Cement Restrictor

FDA 510(k) K220838 · Howmedica Osteonics, Dba Stryker Orthopaedics

Substantially Equivalent

510(k) numberK220838

Submission

Device name
Artisan Bone Plug, Universal Cement Restrictor
Applicant
Howmedica Osteonics, Dba Stryker Orthopaedics
Mahwah, NJ, US
Received
March 22, 2022
Decision date
May 20, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LZN – Cement Obturator
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code LZN

510(k)DeviceApplicantDecision
K061824Tornier Cement RestrictorLZN · Traditional Tornier09/14/2006SE
K032685Cemstop Cement RestrictorLZN · Traditional Teknimed, S.A.11/26/2003SE
K023680Biobuck Cement RestrictorLZN · Special Smith & Nephew, Inc.11/19/2002SE
K011943Impro Vise Absorbable Cement Flow RestrictorLZN · Traditional Kensey Nash Corp.09/19/2001SE
K010840SynplugLZN · Special Isotis NV04/20/2001SE
K993841Cemstop Cement RestrictorLZN · Traditional Encore Orthopedics, Inc.05/04/2000SE
K000587Shuttle StopLZN · Traditional Isotis NV05/04/2000SE
K992462Osteonics Universal Distal Cement PlugLZN · Traditional Howmedica Osteonics Corp.08/13/1999SE
K972411Link Cement PlugLZN · Traditional Turnkey Intergration USA, Inc.08/29/1997SE
K970779Osteonics Tibial Tray Screw Hole PlugsLZN · Traditional Osteonics Corp.05/09/1997SE

Questions and answers

When was Artisan Bone Plug, Universal Cement Restrictor cleared by the FDA?

Artisan Bone Plug, Universal Cement Restrictor (K220838) received a 510(k) decision of Substantially Equivalent on May 20, 2022, 59 days after the submission was received.

What is the product code of K220838?

The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.