Atlas FDA

PRO-FEMUR R

FDA 510(k) clearance K003016 · decided 2000-12-13

Clearance details

K-number
K003016
Device name
PRO-FEMUR R
Applicant
Wrightmedicaltechnologyinc
Decision
Substantially Equivalent
Date received
2000-09-27
Decision date
2000-12-13
Days to decision
77 days
Clearance type
Abbreviated
Product code
LWJ
Device class
2
Regulation number
888.3360
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Arlington, TN, US
Third-party review
No
Expedited review
No

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U2 HIP STEM, TI PLASMA SPRAY (K062978)United Orthopedic Corp.2007-01-16
UNISYN HA PLASMA MODULAR HIP (K062383)Hayes Medical, Inc.2006-12-21
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BETACONE HIP PROSTHESIS SYSTEM (K051826)Waldemar Link GmbH & Co. KG2005-11-18
U2 ACETABULAR COMPONENT (K050262)United Orthopedic Corp.2005-08-15
EXCIA TOTAL HIP SYSTEM (K042344)Aesculap, Inc.2005-03-16
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (K040685)Osteoimplant Technology, Inc.2005-01-25

Recalls involving this device

RecordFirmDate
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA0 recall (Z-2941-2020)MicroPort Orthopedics Inc.2020-09-18
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip pros recall (Z-2942-2020)MicroPort Orthopedics Inc.2020-09-18
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Num recall (Z-2948-2020)MicroPort Orthopedics Inc.2020-09-09
PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in recall (Z-2588-2016)MicroPort Orthopedics Inc.2016-08-18
Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and recall (Z-0183-2013)Wright Medical Technology Inc2012-10-31
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIB recall (Z-0184-2013)Wright Medical Technology Inc2012-10-31
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lo recall (Z-0185-2013)Wright Medical Technology Inc2012-10-31
Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cemen recall (Z-0867-2007)Wright Medical Technology Inc2007-06-07
Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, T recall (Z-0868-2007)Wright Medical Technology Inc2007-06-07

PMA approvals by this applicant

RecordFirmDate
ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011)Wrightmedicaltechnologyinc2000-09-27
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004)Wrightmedicaltechnologyinc1999-08-11
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008)Wrightmedicaltechnologyinc1999-06-02
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006)Wrightmedicaltechnologyinc1999-04-21
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005)Wrightmedicaltechnologyinc1999-03-18
ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003)Wrightmedicaltechnologyinc1999-01-14
ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002)Wrightmedicaltechnologyinc1998-11-25
ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001)Wrightmedicaltechnologyinc1998-09-11