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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Product CodeHRY
Regulation Number 888.3530
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-22-2021
2 Biomet U.K., Ltd. II Jun-29-2011
3 Biomet, Inc. II Jan-26-2023
4 Biomet, Inc. II Dec-17-2020
5 Biomet, Inc. II May-28-2020
6 Biomet, Inc. II Jun-15-2015
7 Biomet, Inc. II Jul-11-2013
8 DePuy Orthopaedics, Inc. II Mar-20-2018
9 Exactech, Inc. II Oct-04-2021
10 Materialise USA LLC II Jan-03-2014
11 MicroPort Orthopedics Inc. II Nov-22-2022
12 Stryker Howmedica Osteonics Corp. II Jan-12-2009
13 Zimmer Biomet, Inc. II Mar-27-2017
14 Zimmer Biomet, Inc. II Jan-06-2017
15 Zimmer, Inc. II Mar-20-2014
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