Implex Corp.
Medical device manufacturer in Allendale, NJ.
65510(k) clearances
0PMA approvals
0recalls
Device types
- JWH Prosthesis, Knee, Patellofemorotibial… 17
- JDI Prosthesis, Hip, Semi-Constrained… 10
- LPH Prosthesis, Hip, Semi-Constrained… 10
- MQP Spinal Vertebral Body Replacement Device 8
- EZX Mesh, Surgical, Metal 3
- MEH Prosthesis, Hip, Semi-Constrained… 2
- LZO Prosthesis, Hip, Semi-Constrained… 2
- MBH Prosthesis, Knee, Patello/Femorotibial… 2
- LWJ Prosthesis, Hip, Semi-Constrained… 2
- FTM Mesh, Surgical 1
- JDK Prosthesis, Hip, Cement Restrictor 1
- KWS Prosthesis, Shoulder, Semi-Constrained… 1
- KWT Prosthesis, Shoulder, Non-Constrained… 1
- KWI Prosthesis, Elbow, Hemi-, Radial, Polymer 1
- MBI Fastener, Fixation, Nondegradable, Soft… 1
- KWY Prosthesis, Hip, Hemi-, Femoral… 1
- LZN Cement Obturator 1
- HWC Screw, Fixation, Bone 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | 09/23/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | 06/17/2005SE |
| K040487 | Trabecular Metal Knee System AugmentsMBH · Traditional | 12/21/2004SE |
| K040630 | Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZJWH · Traditional | 09/30/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | 07/14/2004SE |
| K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsJWH · Traditional | 01/08/2004SE |
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZJDK · Special | 11/19/2003SE |
| K032527 | Hedrocel Vertebral Body ReplacementMQP · Special | 10/31/2003SE |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | 10/02/2003SE |
| K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…KWS · Traditional | 09/23/2003SE |
| K032282 | Modification to Hedrocel Trabecular Metal Reconstruction SystemEZX · Special | 08/21/2003SE |
| K031462 | The Nexgen Knee System Uncemented ComponentsMBH · Traditional | 08/06/2003SE |
| K031823 | Hedrocel Vertebral Body Replacement, Model 06-172-00XX1MQP · Special | 07/11/2003SE |
| K023882 | The Hedrocel Trabecular Metal Reconstruction SystemEZX · Traditional | 02/19/2003SE |
| K024161 | Nexgen Complete Knee Solution - Trabecular Metal AugmentsJWH · Special | 01/15/2003SE |
| K022377 | The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306KWT · Traditional | 12/10/2002SE |
| K022966 | Proxilock Hip Prosthesis; Size 12/36LWJ · Special | 10/02/2002SE |
| K022563 | Hydrocel Vertebral Body Replacement, Model 06-172-00XX1MQP · Special | 08/30/2002SE |
| K021967 | Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2MQP · Special | 07/17/2002SE |
| K021970 | The Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer Cat. #) and…LPH · Special | 07/12/2002SE |
| K021025 | Modification to Hedrocel Vertebral Body Replacement, Model Xx-Yyy-ZzzzMQP · Special | 05/20/2002SE |
| K020295 | Nexgen LPS Trabecular Metal Monoblock Tibia; Zimmer Cat # 00-5886-XXYY, Implex Part #…JWH · Special | 02/12/2002SE |
| K010378 | Hedrocel Vertebral Body Replacement, Model Xx-Yyy-ZzzzMQP · Traditional | 01/28/2002SE |
| K012866 | The Nexgen TMT Tibia, Models 00-5886-XXYY, 05-120-XXYY-0JWH · Special | 09/26/2001SE |
| K012507 | The Trabecular Metal Technology Acetabular Augment System, Models 4893-XX-YY (Zimmer)…LPH · Special | 08/30/2001SE |
| K012095 | The LPS - Continuum TM Hybrid Tibia, Models 32-5886-2Y-XX (Zimmer) and 05-119-XXYY1-0…JWH · Special | 07/26/2001SE |
| K011904 | Nexgen Primary Porous Patella, Model 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-6…JWH · Special | 07/19/2001SE |
| K004013 | Implex Continuum Knee System-Patellar Components, Model 04-XX-YYYYYJWH · Special | 01/25/2001SE |
| K003181 | Implex Continuum Hip System Acetabular Components - Model Xx-Yyy-ZzzzLPH · Special | 11/07/2000SE |
| K001759 | Hedrocel Revision Cup, Model 02-2YY-ZZZZJDI · Traditional | 08/24/2000SE |
| K001471 | The Implex Hedrocel Acetabular Augment, Xx-Yyy-ZzzzLWJ · Traditional | 08/07/2000SE |
| K001039 | The Implex Hedrocel Modular Elliptical Acetabular CupLPH · Abbreviated | 06/15/2000SE |
| K001307 | Continuum Knee System-Ps Femoral Components- Porous, Model Xx-Yyy-ZzzzzJWH · Special | 05/23/2000SE |
| K990330 | Cross Linked Polyethylene Acetabular Components,Model Xx-Yy-ZzzzzzJDI · Traditional | 03/01/2000SE |
| K994076 | Implex Hedrocel PS Tibial Component, Model Hedrocel Posterior Stabilized Tibial…JWH · Traditional | 02/18/2000SE |
| K992409 | The Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZJDI · Traditional | 10/08/1999SE |
| K991869 | Cobrex Hip Stem, Model 01-128-XXXXXJDI · Abbreviated | 07/14/1999SE |
| K983837 | Hedrocel Acetabular Cage SystemLPH · Traditional | 07/01/1999SE |
| K990183 | Implex Alumina Femoral HeadLZO · Traditional | 06/11/1999SE |
| K984290 | Implex Radial Head Replacement SystemKWI · Traditional | 06/01/1999SE |
| K983835 | Implex Continuum Patella-Revision Hedrocel PatellaJWH · Traditional | 03/15/1999SE |
| K984291 | Continuum Knee System Cobalt Chromium Alloy Tibial ComponentJWH · Traditional | 02/01/1999SE |
| K982751 | Implex Screw and Washer SystemMBI · Traditional | 02/01/1999SE |
| K980637 | Implex Continuum Knee Unity Tibial ComponentJWH · Traditional | 12/16/1998SE |
| K983128 | Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-XXYYY, 02-247-XXYYY…JDI · Traditional | 12/03/1998SE |
| K982302 | Implex Continuum Knee - Hedrocel Tibial SpacersJWH · Traditional | 07/31/1998SN |
| K981560 | Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 SystemJWH · Traditional | 06/08/1998SE |
| K980781 | Implex Continuum Knee- Hedrocel Revision Femoral SpacersJWH · Traditional | 05/22/1998SE |
| K980486 | Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 SystemJDI · Traditional | 04/14/1998SE |
| K971705 | Implex Hep Acetabular Cup System, CementedJDI · Traditional | 08/06/1997SE |
| K971789 | Implex Continuum Porous PatellarJWH · Traditional | 07/24/1997SN |
| K964509 | Implex A-240 Hep Acetabular Cup SystemLPH · Traditional | 06/19/1997SE |
| K970447 | Implex Bipolar Hip SystemKWY · Traditional | 04/30/1997SE |
| K964882 | Implex Replacement Acetabular Cup InsertLPH · Traditional | 03/13/1997SE |
| K962468 | Hedrocel Acetabular RestrictorJDI · Traditional | 02/03/1997SE |
| K955117 | Implex Ceramic HeadLZO · Traditional | 04/05/1996SE |
| K941612 | F-230 Porous Femoral Hip Stem (Cementless)LPH · Traditional | 07/06/1995SN |
| K943378 | Implex Cement Restrictor SystemLZN · Traditional | 09/23/1994SE |
| K935990 | F-220 Press-Fit Femoral Hip Stem SystemMEH · Traditional | 07/13/1994SN |
| K932924 | Implex A-230 Porous Acetabular Cup Syst. CementedLPH · Traditional | 05/12/1994SE |
| K932923 | Implex A-230 Porous Acetabular Cup Syst.CementlessLPH · Traditional | 05/03/1994SE |
| K931187 | Implex Acetabular Cup Screw SystemHWC · Traditional | 02/07/1994SE |
| K926134 | H-220 Press-Fit Acetabular Cup SystemMEH · Traditional | 10/15/1993SE |
| K926323 | H-110 Acetabular Cup SystemJDI · Traditional | 05/26/1993SE |
| K925348 | Implex H-110 and H-120 Cemented Hip Stem SystemJDI · Traditional | 05/12/1993SE |