EMPOWR™ blade stem

FDA 510(k) K223779 · Encore Medical, LLC

Substantially Equivalent

510(k) numberK223779

Submission

Device name
EMPOWR™ blade stem
Applicant
Encore Medical, LLC
Austin, TX, US
Received
December 16, 2022
Decision date
February 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3358
Specialty
Orthopedic
Implant
Yes

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K253630Mpact 3D Metal FoamLPH · Traditional Medacta International S.A.08/28/2026SE
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K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional Howmedica Osteonics Corp., Dba Stryker…07/10/2026SE
K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional Nextstep Arthopedix, LLC06/05/2026SE
K251270Taperloc® Complete Hip StemLPH · Traditional Biomet, Inc.05/19/2026SE
K252623G7® Revision Acetabular SystemLPH · Traditional Zimmer, Inc.02/04/2026SE
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyLPH · Traditional Medacta International S.A.01/28/2026SE
K252067Velora Acetabular SystemLPH · Traditional Restor3D, Inc.12/05/2025SE
K252846TaperSet™ Hip SystemLPH · Special Shalby Advanced Technologies, Inc. Dba Consensus…11/20/2025SE
K251833EMPOWR Acetabular® Liner ExtensionLPH · Traditional Encore Medical L.P.11/12/2025SE

More from Encore Medical L.P.

510(k)DeviceDecision
K052320Encore CLP Offset Total Hip SystemKWA · Traditional 12/30/2005SE
K052086Encore Reverse Shoulder Prosthesis Humeral Stem AdapterPHX · Special 08/31/2005SE

Questions and answers

When was EMPOWR™ blade stem cleared by the FDA?

EMPOWR™ blade stem (K223779) received a 510(k) decision of Substantially Equivalent on February 13, 2023, 59 days after the submission was received.

What is the product code of K223779?

The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.