Home / 510(k) Clearances / K201157

510(k) K201157

Prime BIOFOAM® Multi-Hole Shells by Microport Orthopedics, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2021
Date Received
April 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Microport Orthopedics, Inc.

  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Techniqu (February 18, 2025)
  • K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips (April 18, 2024)
  • K240452 — Ceramic Femoral Head (April 12, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233507 — EVOLUTION® Tibial Cones (January 18, 2024)
  • K231947 — EVOLUTION® Cement Keel (October 31, 2023)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K213817 — MPO Knee Instruments; MPO PROPHECY Knee Instruments (January 5, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)

Other clearances for product code MBL

  • K201701 — R3 HA Coated Acetabular Shells (October 6, 2020)
  • K182535 — R3 Anteverted Liners (November 19, 2018)
  • K161233 — OXINIUM DH Fermoral Heads (December 14, 2016)
  • K122382 — DYNASTY BIOFOAM SHELL (October 22, 2012)
  • K113848 — R3 XLPE LINERS (April 27, 2012)
  • K102370 — R3 XLPE ANTEVERTED LINERS (January 19, 2011)
  • K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (January 26, 2010)
  • K092386 — R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (November 3, 2009)
  • K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (June 6, 2007)
  • K061253 — REFLECTION 3 ACETABULAR SYSTEM (May 31, 2006)