ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing

FDA Premarket Approval P060037 S009

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the addition of prolong highly crosslinked polyethylene tibial articular surfaces to the nexgen lps-flex mobile and lps-mobile bearing knee system.

DeviceZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS
Classification NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
ApplicantZIMMER, INC.
Date Received2009-04-24
Decision Date2010-11-03
PMAP060037
SupplementS009
Product CodeNJL
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708

Supplemental Filings

Supplement NumberDateSupplement Type
P060037Original Filing
S082 2022-09-30 30-day Notice
S081
S080 2022-07-25 Special (immediate Track)
S079 2022-05-09 30-day Notice
S078 2022-03-07 30-day Notice
S077 2022-01-31 30-day Notice
S076 2021-12-10 30-day Notice
S075 2021-09-30 30-day Notice
S074 2021-08-10 30-day Notice
S073
S072 2021-06-21 30-day Notice
S071 2021-06-10 30-day Notice
S070 2020-11-25 30-day Notice
S069 2020-09-28 Real-time Process
S068 2020-09-21 30-day Notice
S067 2020-09-17 30-day Notice
S066 2020-07-28 30-day Notice
S065 2020-06-16 30-day Notice
S064 2020-05-07 30-day Notice
S063
S062 2019-09-26 30-day Notice
S061 2019-07-11 30-day Notice
S060 2019-06-03 30-day Notice
S059
S058
S057 2018-11-07 30-day Notice
S056 2018-04-23 30-day Notice
S055 2018-02-27 30-day Notice
S054 2018-02-20 30-day Notice
S053 2017-10-19 30-day Notice
S052 2017-09-29 30-day Notice
S051 2017-09-07 30-day Notice
S050 2017-08-31 30-day Notice
S049 2017-06-07 30-day Notice
S048 2016-11-23 30-day Notice
S047 2016-09-08 Normal 180 Day Track No User Fee
S046 2016-08-08 30-day Notice
S045 2016-05-03 30-day Notice
S044 2016-03-31 30-day Notice
S043 2015-12-17 Special (immediate Track)
S042 2015-10-30 30-day Notice
S041 2015-10-16 30-day Notice
S040 2015-09-30 30-day Notice
S039 2015-08-12 30-day Notice
S038 2015-06-29 135 Review Track For 30-day Notice
S037 2015-06-26 30-day Notice
S036 2015-06-22 Special (immediate Track)
S035 2015-03-17 30-day Notice
S034 2015-02-24 30-day Notice
S033 2014-12-04 30-day Notice
S032 2014-09-30 135 Review Track For 30-day Notice
S031 2014-08-28 135 Review Track For 30-day Notice
S030 2014-02-18 Normal 180 Day Track No User Fee
S029 2014-01-22 30-day Notice
S028 2013-09-30 135 Review Track For 30-day Notice
S027 2013-09-23 135 Review Track For 30-day Notice
S026 2013-08-08 Normal 180 Day Track No User Fee
S025
S024 2013-07-15 135 Review Track For 30-day Notice
S023 2013-07-01 30-day Notice
S022 2013-05-23 30-day Notice
S021 2013-03-25 135 Review Track For 30-day Notice
S020 2012-09-27 135 Review Track For 30-day Notice
S019 2012-08-21 135 Review Track For 30-day Notice
S018 2012-07-13 30-day Notice
S017 2012-04-06 135 Review Track For 30-day Notice
S016 2012-01-12 30-day Notice
S015 2011-11-23 30-day Notice
S014 2011-07-05 135 Review Track For 30-day Notice
S013 2010-05-12 Special (immediate Track)
S012 2010-04-06 Normal 180 Day Track No User Fee
S011 2009-06-10 30-day Notice
S010 2009-05-22 Special (immediate Track)
S009 2009-04-24 Normal 180 Day Track
S008 2009-04-21 30-day Notice
S007 2008-11-25 Real-time Process
S006 2008-10-10 135 Review Track For 30-day Notice
S005 2008-09-29 Normal 180 Day Track
S004 2008-09-02 Normal 180 Day Track No User Fee
S003 2008-06-06 135 Review Track For 30-day Notice
S002
S001 2008-01-29 30-day Notice

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