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 1, 2000 | K002441 | FENNING HIP STEM DePuy Orthopaedics, Inc. | LZO |
| Aug 4, 2000 | K001449 | TRIDENT ACETABULAR SHELLS: PS Howmedica Osteonics Corp. | LZO |
| Jun 5, 2000 | K993874 | BOFOR REVISION COUP Plus Orthopedics | LZO |
| Apr 24, 2000 | K000432 | RESPONSE 2000 CEMENTED HIP STEM DePuy Orthopaedics, Inc. | LZO |
| Apr 24, 2000 | K000392 | RESPONSE 2000 HIP STEM DePuy Orthopaedics, Inc. | LZO |
| Feb 18, 2000 | K992359 | MRS-TITAN Rotec Medizintechnik GmbH, DE | LZO |
| Feb 15, 2000 | K994184 | PLR SPLINED REVISION STEM Biomet, Inc. | LZO |
| Feb 11, 2000 | K993889 | EXETER CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. | LZO |
| Jan 28, 2000 | K991162 | BIOLOX ALUMINA CERAMIC FEMORAL HEAD Smith & Nephew, Inc. | LZO |
| Jan 21, 2000 | K992403 | MRP-TITAN Rotec Medizintechnik GmbH, DE | LZO |
| Dec 2, 1999 | K993043 | MS-30 FEMORAL STEM Sulzer Orthopedics, Inc. | LZO |
| Nov 23, 1999 | K992235 | ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS Corin USA | LZO |
| Sep 22, 1999 | K992144 | BIOPRO RIMMED ACETABULAR COMPOMENT Biologically Oriented Prostheses | LZO |
| Aug 27, 1999 | K990261 | PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) Plus Orthopedics | LZO |
| Jul 30, 1999 | K991708 | ZIRCONIA 22.22MM CERAMIC MODULAR HEADS Biomet, Inc. | LZO |
| Jun 29, 1999 | K991952 | OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS Howmedica Osteonics Corp. | LZO |
| Jun 11, 1999 | K990183 | IMPLEX ALUMINA FEMORAL HEAD Implex Corp. | LZO |
| Jun 1, 1999 | K991226 | FOUNDATION POROUS HIP STEM Encore Orthopedics, Inc. | LZO |
| Dec 22, 1998 | K983404 | TYPE 3 FEMORAL COMPONENTS Howmedica Corp. | LZO |
| Jul 17, 1998 | K981847 | BIOLOX ALUMINA CERAMIC FEMORAL HEAD Smith & Nephew, Inc. | LZO |
| Jun 25, 1998 | K981302 | SMC 28MM CERAMIC FEMORAL HEADS Signal Medical Corp. | LZO |
| May 29, 1998 | K981201 | OSTEOLOCK ACETABULAR CUP Howmedica Corp. | LZO |
| Apr 29, 1998 | K980774 | OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS Osteonics Corp. | LZO |
| Apr 16, 1998 | K980473 | PRESS-FIT STEM Encore Orthopedics, Inc. | LZO |
| Apr 16, 1998 | K980239 | PARTNERSHIP CALCAR FEMORAL COMPONENTS Howmedica, Inc. | LZO |
| Apr 9, 1998 | K980081 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD Johnson & Johnson Professionals, Inc. | LZO |
| Jan 6, 1998 | K973837 | CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL Sulzer Orthopedics, Inc. | LZO |
| Dec 19, 1997 | K973681 | NATURAL-HIP COCR OFFSET STEM Sulzer Orthopedics, Inc. | LZO |
| Dec 5, 1997 | K972228 | MERIDIAN TITANIUM FEMORAL STEMS Howmedica, Inc. | LZO |
| Nov 24, 1997 | K973261 | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD Whiteside Biomechanics, Inc. | LZO |
| Nov 20, 1997 | K973307 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD Johnson & Johnson Professionals, Inc. | LZO |
| Nov 14, 1997 | K973087 | MOST HEX INTRAMEDULLARY (I/M) STEM Sulzer Orthopedics, Inc. | LZO |
| Nov 3, 1997 | K972893 | PARTNERSHIP REVISION FEMORAL STEMS Howmedica Corp. | LZO |
| Oct 15, 1997 | K972690 | ZIRCONIA CERAMIC FEMORAL HEAD Zimmer, Inc. | LZO |
| Oct 1, 1997 | K972637 | PRECEDENT REVISION HIP SYSTEM Sulzer Orthopedics, Inc. | LZO |
| Sep 23, 1997 | K972361 | V40 ZIRCONIA FEMORAL HEADS Howmedica, Inc. | LZO |
| Aug 22, 1997 | K970675 | HEADLOC CERAMIC HEAD Ortho Development Corp. | LZO |
| Aug 11, 1997 | K964431 | ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) Biomet, Inc. | LZO |
| Jul 30, 1997 | K971752 | ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) Zimmer, Inc. | LZO |
| Jul 30, 1997 | K971721 | WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD Whiteside Biomechanics, Inc. | LZO |
| Jul 16, 1997 | K971497 | OSTEONICS ANTEVERTED NECK HIP STEM Osteonics Corp. | LZO |
| Jul 16, 1997 | K971414 | ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS Smith & Nephew, Inc., Orthopaedic Div. | LZO |
| Jul 9, 1997 | K971435 | HEADLOC CERAMIC FEMORAL HEADS Ortho Development Corp. | LZO |
| Jul 9, 1997 | K971426 | HEADLOC CERAMIC HEAD Ortho Development Corp. | LZO |
| Jul 9, 1997 | K971409 | OSTEONICS ALUMINA C-TAPER HEAD Osteonics Corp. | LZO |
| Jun 27, 1997 | K965002 | ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND Encore Orthopedics, Inc. | LZO |
| Jun 5, 1997 | K970846 | 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD Landos, Inc. | LZO |
| May 2, 1997 | K970490 | PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT Stelkast Company | LZO |
| Apr 9, 1997 | K970200 | RELIANCE PF FEMORAL STEMS Howmedica Corp. | LZO |
| Apr 8, 1997 | K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM Intermedics Orthopedics | LZO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.