R3 Delta Ceramic Acetabular System

FDA Premarket Approval P150030 S011

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

The firm is notifying the fda of the addition of manufacturing equipment used in the raw material forging of the polarstem standard and lateral femoral stems with ti/ha, which are approved for use in combination with the r3 delta ceramic acetabular system.

DeviceR3 Delta Ceramic Acetabular System
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantSmith & Nephew, Inc.
Date Received2021-06-07
Decision Date2021-06-29
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016

Supplemental Filings

Supplement NumberDateSupplement Type
P150030Original Filing
S011 2021-06-07 30-day Notice
S010 2021-06-04 30-day Notice
S009 2021-06-04 30-day Notice
S008 2020-07-22 Normal 180 Day Track No User Fee
S007 2019-05-09 30-day Notice
S006 2018-11-21 Real-time Process
S005 2018-08-22 Normal 180 Day Track No User Fee
S004 2017-11-24 30-day Notice
S003 2017-08-17 Normal 180 Day Track No User Fee
S002 2017-05-04 30-day Notice
S001 2016-11-07 Normal 180 Day Track No User Fee


Device IDPMASupp
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00885556498590 P150030 000
00885556498644 P150030 000
00885556498699 P150030 000
00885556498743 P150030 000
00885556498798 P150030 000
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00885556498941 P150030 000
00885556498996 P150030 000
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00885556499092 P150030 000
00885556499146 P150030 000
00885556499191 P150030 000
00885556499245 P150030 000
00885556498545 P150030 000

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