Panels › Orthopedic › Product code LZO · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation 888.3353
9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
Top companies in LZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 34 | 35 |
| Stryker Howmedica Osteonics | 0 | 51 |
| Medacta International | 38 | 0 |
| Exactech, Inc. | 21 | 15 |
| Corin U.S.A. Limited | 27 | 5 |
| Biomet, Inc. | 21 | 8 |
| Howmedica Osteonics | 24 | 2 |
| Smith & Nephew, Inc. | 24 | 2 |
| Microport Orthopedics, Inc. | 13 | 8 |
| Howmedica Corp. | 19 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 1994 | K933108 | TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS Landos, Inc. | LZO |
| Aug 18, 1994 | K935193 | CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM U.S. Medical Products, Inc. | LZO |
| Jul 12, 1994 | K941942 | SOLUTION HIP Depuy, Inc. | LZO |
| Jul 12, 1994 | K941847 | 5/8 POROCOAT AML HIP POROCOAT POROUS COATING Depuy, Inc. | LZO |
| Jul 6, 1994 | K934457 | STABILITY HIP STEM WITH POROCOAT Depuy, Inc. | LZO |
| Jun 16, 1994 | K935185 | MORPHOMETRIC TOTAL HIP PROSTHESIS Landos, Inc. | LZO |
| Jun 15, 1994 | K932935 | TITAN DYSPLASIC TOTAL HIP PROSTHESIS Landos, Inc. | LZO |
| Jun 14, 1994 | K931617 | EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT Exactech, Inc. | LZO |
| May 27, 1994 | K932222 | SLT FEMORAL HEAD Dow Corning Wright | LZO |
| May 18, 1994 | K934694 | KIRSCHNER ZIRCONIA FEMORAL HEAD Kirschner Medical Corp. | LZO |
| May 18, 1994 | K933499 | CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM U.S. Medical Products, Inc. | LZO |
| May 16, 1994 | K933567 | EUROFORM TOTAL HIP PROSTHESIS Landos, Inc. | LZO |
| Apr 19, 1994 | K933203 | APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP Intermedics Orthopedics | LZO |
| Apr 19, 1994 | K931571 | LINK CERAMIC HEADS 12/14 X 32MM Link America, Inc. | LZO |
| Mar 30, 1994 | K922247 | KINAMED REALITY TOTAL HIP SYSTEM Kinamed, Inc. | LZO |
| Mar 29, 1994 | K931929 | TECHMEDICA CONTINUUM HIP SYSTEM Techmedica, Inc. | LZO |
| Mar 28, 1994 | K931572 | LINK CERAMIC HEADS 14/16 X 32MM Link America, Inc. | LZO |
| Mar 10, 1994 | K932519 | OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM Osteonics Corp. | LZO |
| Mar 10, 1994 | K926395 | ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM Depuy, Inc. | LZO |
| Mar 10, 1994 | K925345 | ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) Biomet, Inc. | LZO |
| Feb 22, 1994 | K930788 | ZIRCONIA CERAMIC FEMORAL HEAD Smith & Nephew Richards, Inc. | LZO |
| Feb 16, 1994 | K921225 | INTEGRAL TOTAL HIP SYSTEM Biomet, Inc. | LZO |
| Feb 16, 1994 | K921224 | BIMETRIC TOTAL HIP SYSTEM Biomet, Inc. | LZO |
| Feb 16, 1994 | K921181 | MALLORY-HEAD TOTAL HIP SYSTEM Biomet, Inc. | LZO |
| Feb 9, 1994 | K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET Johnson & Johnson Orthopaedics, Inc. | LZO |
| Jan 7, 1994 | K930963 | SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS Encore Orthopedics, Inc. | LZO |
| Jan 7, 1994 | K925682 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED Biopro, Inc. | LZO |
| Oct 4, 1993 | K930712 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR Johnson & Johnson Orthopaedics, Inc. | LZO |
| Jul 27, 1993 | K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS Techmedica, Inc. | LZO |
| Jun 22, 1993 | K915222 | WALKER HIP PROSTHESIS Zimmer, Inc. | LZO |
| Jun 14, 1993 | K923734 | TOTAL HIP PROTHESIS FEMORAL COMPONENT Intermedics Orthopedics | LZO |
| May 5, 1993 | K920968 | INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD Dow Corning Wright | LZO |
| Apr 20, 1993 | K925695 | OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD Osteonics Corp. | LZO |
| Feb 12, 1993 | K925512 | CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION Dow Corning Wright | LZO |
| Dec 7, 1992 | K923583 | ORTHOMET PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | LZO |
| Nov 6, 1992 | K921836 | PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD Orthomet, Inc. | LZO |
| Nov 4, 1992 | K915641 | ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER Biomet, Inc. | LZO |
| Nov 3, 1992 | K920290 | KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL Kinamed, Inc. | LZO |
| Oct 30, 1992 | K920219 | KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL Kinamed, Inc. | LZO |
| Oct 22, 1992 | K921111 | S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD Joint Medical Products Corp. | LZO |
| Oct 20, 1992 | K915396 | OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD Osteonics Corp. | LZO |
| Oct 15, 1992 | K920145 | BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM Biopro, Inc. | LZO |
| Aug 31, 1992 | K920593 | CERAMIC FEMORAL HEAD Dow Corning Wright | LZO |
| May 18, 1992 | K920756 | FELDMUHLE CERAMIC HEAD Link America, Inc. | LZO |
| May 15, 1992 | K920577 | HOWEDICA ZIRCONIA FEMORAL HEAD Howmedica Corp. | LZO |
| Feb 19, 1992 | K915310 | KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL Kinamed, Inc. | LZO |
| Feb 19, 1992 | K915309 | KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL Kinamed, Inc. | LZO |
| Jan 31, 1992 | K915184 | HOWMEDICA ALUMINA FEMORAL HEAD Pfizer Hospital Products Group, Inc. | LZO |
| Jan 16, 1992 | K913420 | ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF Biomet, Inc. | LZO |
| Jan 13, 1992 | K914676 | ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER Zimmer, Inc. | LZO |
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