Product code KWA— Orthopedic
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- Classification name
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device class
- Class 3
- Regulation
- 21 CFR 888.3330
- Advisory panel
- Orthopedic
- Total cleared
- 114
- First cleared
- Most recent
Market context for product code KWA
FDA has cleared devices under product code KWA between 1978 and 2012, filed by 29 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.
Clearances per year
last 15 years- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1993
Top applicants under product code KWA
Adverse events under product code KWA
product code KWA- Death
- 38
- Injury
- 10,439
- Malfunction
- 1,862
- Total
- 12,339
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 KWA
1–100 of 114- K122778 — PROFEMUR Z REVISION HIP STEM
- K121544 — DYNASTY BIOFOAM SHELL
- K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
- K113322 — CONSERVE THIN SHELL
- K112080 — PRESERVE HIP STEM
- K112150 — PROFEMUR GLADIATOR HA HIP STEM
- K113019 — PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
- K111910 — GLADIATOR HIP STEM
- K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
- K110400 — TAPERLOC COMPLETE MICROPLASTY STEM
- K111698 — PROFEMUR(R) E CEMENTLESS HIP STEM
- K111699 — PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
- K110399 — GLADIATOR PLASMA CLASSIC HIP STEM
- K110029 — CONSERVE BIO FOAM SHELL
- K103755 — TAPERLOC COMPLETE, SIZE 5 AND 6
- K102565 — ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
- K100469 — ARCOS INTERLOCKING DISTAL STEMS
- K101086 — TAPERLOC COMPLETE
- K101475 — COMPRESS ANTI-ROTATION SPINDLES
- K093235 — RINGLOC + HYBRID ACETABULAR SYSTEM
- K092331 — DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110
- K091003 — ZIMMER MMC CUP
- K091973 — METASUL TAPER LINERS, METASUL FEMORAL HEADS
- K090757 — BIOMET MODULAR FEMORAL REVISION SYSTEM
- K091423 — PROFEMUR HIP SYSTEM MODULAR NECKS
- K083651 — REVELATION STEM, MODEL 427-21/42-080/180
- K082924 — DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
- K083642 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K082585 — DEPUY ASPHERE M-SPEC HEAD
- K082446 — BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
- K080991 — DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
- K081090 — PROFEMUR LX 5/8 COATED HIP STEM
- K081007 — ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
- K080663 — PROFEMUR LX REVISION 5/8 COATED HIP STEM
- K073637 — PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
- K071723 — ZIMMER POROLOCK MIS STEM
- K073413 — DEPUY ASR 300 ACETABULAR CUP SYSTEM
- K071856 — ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
- K070221 — FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
- K070274 — ECHO BI-METRIC PRESS-FIT STEMS
- K062994 — LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
- K070359 — DEPUY ASR TAPER SLEEVE ADAPTER
- K063614 — ALTRA FX HIP SYSTEM
- K063251 — ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
- K062998 — COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
- K062426 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K063414 — MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
- K062995 — M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
- K063002 — ALTRA PRESS-FIT HIP SYSTEM
- K061221 — DUPUY S-ROM STD HIP STEM PROSTHESIS
- K061423 — M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
- K060358 — PROFEMUR TL HIP STEM
- K060356 — CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
- K053536 — DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
- K052915 — PROFEMUR XTR HIP STEM
- K053588 — PROFEMUR LX HIP STEM
- K052320 — ENCORE CLP OFFSET TOTAL HIP SYSTEM
- K052888 — POROUS TITANIUM ACETABULAR AUGMENTS
- K050124 — POROUS COATED ACETABULAR COMPONENTS
- K043099 — LINEAGE HA ACETABULAR SHELLS
- K040627 — DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
- K043547 — COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
- K050251 — BALANCE HIP SYSTEM
- K043073 — PROCOTYL-E ACETABULAR SYSTEM
- K042530 — CONSERVE PLUS HA ACETABULAR SHELLS
- K040354 — METAL/METAL HIP SYSTEM
- K033943 — ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
- K042037 — M2A MAGNUM SYSTEM
- K033634 — EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
- K041425 — CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
- K031963 — CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
- K023786 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
- K021349 — METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
- K011110 — M2A ACETABULAR SYSTEM
- K003758 — ALLOFIT ACETABULAR SYSTEM
- K003250 — FMP METAL/METAL ACETABULAR INSERT
- K003523 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K002883 — PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K002379 — M2A 28MM RINGLOC LINER
- K001523 — ULTIMA METAL-ON-METAL ACETABULAR CUP
- K001536 — INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
- K993438 — METAL ON METAL ACETABULAR SYSTEM
- K993569 — APR METASUL ACETABULAR INSERT
- K974728 — INTER-OP METASUL ACETABULAR SYSTEM
- K922868 — THOMPSON TYPE HIP PROTHESIS
- K902110 — MODIFIED FREEMAN ACETABULAR CUP
- K902111 — MODIFIED FREEMAN REVISION ACETABULAR CUP
- K901626 — H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
- K895157 — S.A.F. ACETABULAR CUP
- K885049 — RS-CUP ACETABULAR PROSTHESIS
- K882671 — SAMUELSON SCREWLOC CUP
- K882675 — ATH METAL:UHMWPE TOTAL HIP SYSTEM
- K872768 — OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
- K872985 — SAMUELSON ACETABULAR CUP
- K870923 — SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
- K870924 — CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
- K871453 — ZWEYMUELLER-SL HIP PROSTHESIS STEM
- K871956 — MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
- K864515 — RING UPM TOTAL HIP REPLACEMENT
- K861723 — (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.