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 |
|---|---|---|---|
| Feb 19, 1997 | K970346 | PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT Kairos Orthopaedics | LZO |
| Jan 27, 1997 | K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT Hayes Medical, Inc. | LZO |
| Jan 27, 1997 | K964357 | NATURAL-HIP SYSTEM COCR STEM Intermedics Orthopedics | LZO |
| Jan 24, 1997 | K964704 | DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM Depuy, Inc. | LZO |
| Jan 14, 1997 | K964249 | BRIDGE LONG STEM FEMORAL COMPONENT Wrightmedicaltechnologyinc | LZO |
| Dec 27, 1996 | K964150 | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD Whiteside Biomechanics, Inc. | LZO |
| Dec 27, 1996 | K953111 | CORAIL Landos, Inc. | LZO |
| Oct 8, 1996 | K955877 | ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD Zimmer, Inc. | LZO |
| Aug 29, 1996 | K962248 | P.F.C. CERAMIC HIP HEAD Johnson & Johnson Professionals, Inc. | LZO |
| Aug 19, 1996 | K962101 | ZWEYMUELLER SL FEMORAL HIP STEM Intermedics Orthopedics | LZO |
| Aug 5, 1996 | K961921 | APR OVERSIZED HIP STEM Intermedics Orthopedics | LZO |
| Aug 5, 1996 | K960588 | WAGNER REVISION STEM Intermedics Orthopedics | LZO |
| Jul 19, 1996 | K961727 | NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM Intermedics Orthopedics | LZO |
| Jul 9, 1996 | K961589 | APR FULLY TEXTURED HIP STEM Intermedics Orthopedics | LZO |
| Jun 7, 1996 | K953690 | CLS STEM (MODIFICATION) Intermedics Orthopedics | LZO |
| Apr 5, 1996 | K955117 | IMPLEX CERAMIC HEAD Implex Corp. | LZO |
| Feb 20, 1996 | K955386 | CONSENSUS ZIRCONIA FEMORAL HEAD U.S. Medical Products, Inc. | LZO |
| Feb 16, 1996 | K955350 | BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM Biomet, Inc. | LZO |
| Jan 31, 1996 | K953925 | FINE GRAIN CAST COBALT CHROMIUM HIP STEMS Biomet, Inc. | LZO |
| Jan 18, 1996 | K954768 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD Biologically Oriented Prostheses | LZO |
| Nov 29, 1995 | K953689 | WAGNER REVISION STEM (MODIFICATION) Intermedics Orthopedics | LZO |
| Nov 29, 1995 | K953688 | CLS ACETABULAR COMPONENT (MODIFICATION) Intermedics Orthopedics | LZO |
| Nov 6, 1995 | K953792 | CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 U.S. Medical Products, Inc. | LZO |
| Oct 20, 1995 | K944689 | ZIRCONIA CERAMIC FEMORAL HEAD Wrightmedicaltechnologyinc | LZO |
| Sep 27, 1995 | K953045 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD Biologically Oriented Prostheses | LZO |
| Sep 19, 1995 | K952686 | BUCHALTER FAUSER FEMORAL COMPONENTS Biomet, Inc. | LZO |
| Aug 8, 1995 | K953169 | STELKAST ALL POLYETHYLENE ACETABULAR CUP Stelkast Company | LZO |
| Jul 3, 1995 | K952418 | V40 ZIRCONIA FEMORAL HEADS Howmedica Corp. | LZO |
| Jun 30, 1995 | K952088 | ZIRCONIA ARTICUL/EZE FEMORAL BALLS Depuy, Inc. | LZO |
| Mar 20, 1995 | K946026 | HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS Howmedica, Inc. | LZO |
| Mar 6, 1995 | K943774 | OSTEONICS RESTORATION MONOLITHIC HIP STEM Osteonics Corp. | LZO |
| Feb 14, 1995 | K945516 | NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM Intermedics Orthopedics | LZO |
| Jan 19, 1995 | K945096 | CDH HIP STEM Howmedica Corp. | LZO |
| Jan 19, 1995 | K945095 | APC FEMORAL COMPONENT Howmedica Corp. | LZO |
| Jan 19, 1995 | K945094 | HNR-PC HIP Howmedica Corp. | LZO |
| Jan 19, 1995 | K945093 | P.C.A. E-SERIES HIP- CEMENTLESS USE Howmedica, Inc. | LZO |
| Jan 19, 1995 | K945092 | P.C.A.PRIMARY HIP- CEMENTLESS USE Howmedica Corp. | LZO |
| Jan 19, 1995 | K945090 | HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD Howmedica Corp. | LZO |
| Jan 19, 1995 | K945089 | SENTRY TOTAL HIP Howmedica Corp. | LZO |
| Jan 18, 1995 | K945091 | HOWMEDICA ALUMINA FEMORAL HEAD Howmedica Corp. | LZO |
| Jan 12, 1995 | K944601 | ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD Zimmer, Inc. | LZO |
| Dec 15, 1994 | K935913 | HOWMEDICA SENTRY S TOTAL HIP SYSTEM Howmedica, Inc. | LZO |
| Dec 9, 1994 | K944209 | APR II NON POROUS HIP STEM Intermedics Orthopedics | LZO |
| Nov 28, 1994 | K935921 | ZIRCONIA CERAMIC FEMORAL HEAD Smith & Nephew Richards, Inc. | LZO |
| Nov 14, 1994 | K936256 | MODULAR CERAMIC FEMORAL HEAD Stelkast Company | LZO |
| Oct 17, 1994 | K943586 | ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) Biomet, Inc. | LZO |
| Oct 14, 1994 | K933942 | SOLUTION BOWED FEMORAL HIP PROTSTHESIS Depuy, Inc. | LZO |
| Oct 6, 1994 | K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT Johnson & Johnson Orthopaedics, Inc. | LZO |
| Oct 4, 1994 | K942330 | APR II FEMORAL COMPONENT (VARIOUS) Intermedics Orthopedics | LZO |
| Sep 28, 1994 | K933275 | P.F.C. CERAMIC HIP HEAD Johnson & Johnson Orthopaedics, Inc. | LZO |
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