Product code LWJ— Orthopedic
MODIFICATION TO PROVIDENT HIP SYSTEM
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Total cleared
- 81
- First cleared
- Most recent
Market context for product code LWJ
FDA has cleared devices under product code LWJ between 1984 and 2012, filed by 37 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2012
- 2011
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code LWJ
Adverse events under product code LWJ
product code LWJ- Injury
- 544
- Total
- 544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LWJ
- K120595 — UNISYN PLUS HIP STEM
- K103518 — TRINITY ACETABULAR SYSTEM
- K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS
- K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
- K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
- K062978 — U2 HIP STEM, TI PLASMA SPRAY
- K062383 — UNISYN HA PLASMA MODULAR HIP
- K061699 — EXCIA
- K051826 — BETACONE HIP PROSTHESIS SYSTEM
- K050262 — U2 ACETABULAR COMPONENT
- K042344 — EXCIA TOTAL HIP SYSTEM
- K040685 — Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
- K033313 — QUATRO M FEMORAL COMPONENT
- K032709 — MODULAR PLUS HIP STEM
- K032110 — PROCLASS PRESS FIT HIP STEM
- K030971 — MODIFICATION TO MODULAR PLUS REVISION STEM
- K023692 — GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
- K030122 — DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
- K024134 — UNI HIP STEM
- K022966 — PROXILOCK HIP PROSTHESIS; SIZE 12/36
- K003649 — TRITON HIP SYSTEM
- K010243 — TRI-FIT FEMORAL STEM
- K003016 — PRO-FEMUR R
- K994146 — EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
- K002941 — ACETABULAR PLATES
- K002575 — INTER-OP DURASUL ACETABULAR INSERTS (4MM)
- K002796 — MODIFICATION TO PROVIDENT HIP SYSTEM
- K002141 — ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
- K001471 — THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
- K001745 — MODIFICATION TO PROVIDENT HIP SYSTEM
- K001942 — SL-PLUS AND SLR-PLUS STEMS
- K994126 — MODULAR-PLUS REVISION STEM
- K993601 — HOWMEDICA OSTEONICS FEMORAL HEADS
- K982936 — OSTEONICS EXTENDED FEMORAL BEARING HEAD
- K971900 — LATERAL FLARE INTERNAL COLLAR (LFIC)
- K972931 — PLUS EPF ACETABULAR CUP
- K973077 — PLUS-FIT ACETABULAR CUP
- K964178 — PRESS-FIT HIP STEM
- K955553 — PERFECTA REVISION HIP SYSTEM
- K962034 — SC, CEMENTLESS HIP SYSTEM
- K962268 — CHROME COBALT BALL HEAD
- K961378 — DELTA HIP PROSTHESIS
- K960633 — PRESS-FIT FLARED SHELL
- K963155 — INTERMOORE FRACTURE HIP STEM (MODIFY)
- K960908 — SRRS PRESSED FIT FEMORAL REVISION COMPONENT
- K954854 — INTERMOORE FRACTURE HIP STEM
- K952776 — LFIC OR FETTO HIP
- K953268 — DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
- K952297 — FOUNDATION TEXTURED STEM
- K950541 — HOWMEDICA V40 22MM FEMORAL HEAD
- K931423 — PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
- K934909 — COBALT CHROME GEMINI
- K933359 — OSTEONICS 22MM, +10 NECK BEARING HEADS
- K921382 — FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
- K923911 — INTRINSIC STEM
- K910664 — MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
- K913708 — VENUS HIP
- K914343 — TI-FIT FEMORAL COMPONENT
- K903563 — HOWMEDICA HNR SYSTEM
- K910010 — Q SYSTEM 28 HIP STEM
- K905254 — THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
- K905186 — GERI TOTAL HIP SYSTEM
- K900262 — ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
- K900435 — ACSYS SHEARER ACETABULAR CUP PROSTHESIS
- K901687 — F-24 FEMORAL HIP PROSTHESIS
- K901594 — H.N. TOTAL HIP PROSTHESIS
- K895702 — KDR ACETABULAR COMPONENT
- K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM
- K894051 — PREMIER-TOTAL HIP
- K893785 — ARC-2F ACETABULAR CUP
- K893584 — GRIPPER II ACETABULAR CUP
- K891539 — CTI II STRAIGHT STEM
- K891262 — KDG ACETABULAR COMPONENT
- K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH
- K883661 — MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
- K883921 — OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
- K881983 — HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
- K881288 — CORIN MODULAR MOORE STEM
- K870088 — S-ROM SUPERCUP ACETABULAR CUP
- K873797 — TI-FIT TOTAL HIP SYSTEM
- K833970 — MICRO-STRUCTURED HS2P HIP STEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.