Biocore9 Acetabular Cup System

FDA 510(k) K212761 · Biocore9, LLC

Substantially Equivalent

510(k) numberK212761

Submission

Device name
Biocore9 Acetabular Cup System
Applicant
Biocore9, LLC
Whippany, NJ, US
Received
August 31, 2021
Decision date
May 17, 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
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
K201219Biocore9 Femoral Head Resurfacing ComponentKXA · Traditional 01/19/2021SE
K193122Biocore9 Humeral Resurfacing SystemHSD · Traditional 05/15/2020SE

Questions and answers

When was Biocore9 Acetabular Cup System cleared by the FDA?

Biocore9 Acetabular Cup System (K212761) received a 510(k) decision of Substantially Equivalent on May 17, 2022, 259 days after the submission was received.

What is the product code of K212761?

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.