NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

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

FDA Premarket Approval P060037

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the zimmer nexgen lps-flex mobile and lps-mobile bearing knees. These devices are indicated for patients with severe knee pain and disability due to osteoarthritis; primary and secondary traumatic arthritis; avascular necrosis of the femoral condyle; or moderate valgus, varus, or flexion deformities (i. E. , valgus/varus deformity of

DeviceNEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
Classification NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
ApplicantZIMMER, INC.
Date Received2006-12-18
Decision Date2007-12-10
Notice Date2008-09-26
PMAP060037
SupplementS
Product CodeNJL
Docket Number08M-0522
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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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