510(k) K003016 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
PRO-FEMUR R
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Dec 13, 2000 |
| Received | Sep 27, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K003016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2020 | MicroPort Orthopedics Inc. PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component. Terminated |
LWJ | None listed |
| Sep 18, 2020 | MicroPort Orthopedics Inc. PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component Terminated |
LWJ | None listed |
| Sep 9, 2020 | MicroPort Orthopedics Inc. PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions:
Item Number Description Description 2
PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME
PHAC1204 PROFEMUR NECK NEUTRA Open, Classified |
LWJ | None listed |
| Aug 18, 2016 | MicroPort Orthopedics Inc. PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature pati Terminated |
LWJ | None listed |
| Oct 31, 2012 | Wright Medical Technology Inc Hip Components:
INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225
INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226
TETE INOX "COLLEGIA" T 28/0 Terminated |
LPH | None listed |
| Oct 31, 2012 | Wright Medical Technology Inc Knee Components:
ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380
INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876
Terminated |
LPH | None listed |
| Oct 31, 2012 | Wright Medical Technology Inc Extremity Components:
PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985
PROTHES Terminated |
LPH | None listed |
| Jun 7, 2007 | Wright Medical Technology Inc Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant. Terminated |
LZO | None listed |
| Jun 7, 2007 | Wright Medical Technology Inc Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant. Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.