Osteonics Corp.
Medical device manufacturer in Allendale, NJ.
178510(k) clearances
0PMA approvals
0recalls
Device types
- JDI Prosthesis, Hip, Semi-Constrained… 29
- JWH Prosthesis, Knee, Patellofemorotibial… 24
- MEH Prosthesis, Hip, Semi-Constrained… 24
- LZO Prosthesis, Hip, Semi-Constrained… 10
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 8
- HWC Screw, Fixation, Bone 8
- LPH Prosthesis, Hip, Semi-Constrained… 7
- KWS Prosthesis, Shoulder, Semi-Constrained… 7
- LWJ Prosthesis, Hip, Semi-Constrained… 6
- HRS Plate, Fixation, Bone 6
- JDK Prosthesis, Hip, Cement Restrictor 6
- MNH Orthosis, Spondylolisthesis Spinal Fixation 5
- HSB Rod, Fixation, Intramedullary And Accessories 4
- HRY Prosthesis, Knee, Femorotibial… 4
- HSX Prosthesis, Knee, Femorotibial… 3
- KWP Appliance, Fixation, Spinal Interlaminal 3
- KWA Prosthesis, Hip, Semi-Constrained (Metal… 3
- JDL Prosthesis, Hip, Semi-Constrained (Metal… 3
- JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis 2
- KWZ Prosthesis, Hip, Constrained, Cemented Or… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983657 | Osteonics Series 7000 Ad Tibial TrayHRY · Traditional | 04/06/2000SE |
| K980070 | Osteonics Ha-Coated DevicesMEH · Traditional | 07/23/1999SE |
| K984375 | Osteonics Spinal System - Sacral Offset Connector AssemblyKWP · Traditional | 04/30/1999SE |
| K982798 | Osteonics Anterior Cervical Compression Plating SystemKWQ · Traditional | 03/25/1999SE |
| K984585 | Osteonics +10 Unipolar Adaptor SleeveKWL · Traditional | 02/24/1999SE |
| K990203 | Osteonics Primary Secur-Fit Plus Hip StemsMEH · Special | 02/18/1999SE |
| K990158 | Osteonics Combination Screw Ring/BlockerMNI · Special | 02/01/1999SE |
| K984302 | Osteonics Spinal System Cylindrical Bone ScrewsMNH · Special | 12/18/1998SE |
| K984353 | Osteo 9MM Ic Tibial NailHSB · Special | 12/16/1998SE |
| K983502 | Osteonics Secur-Fit Ad Generation II Acetabular Component SystemLPH · Traditional | 12/16/1998SE |
| K983382 | Osteonics Ha Generation II Acetabular Component SystemMEH · Traditional | 12/11/1998SE |
| K983508 | Osteo Compression Condyle Screw SystemHWC · Traditional | 12/07/1998SE |
| K983226 | Osteonics X Cemented Hip Stem SeriesJDI · Traditional | 12/04/1998SE |
| K983165 | Osteo 4.0MM Cannulated Screw SystemHWC · Traditional | 12/03/1998SE |
| K983870 | Osteonics Restoration Ha Hip StemsMEH · Special | 12/02/1998SN |
| K983339 | Osteo Dynatroc Proximal Femoral NailHSB · Traditional | 10/27/1998SE |
| K982936 | Osteonics Extended Femoral Bearing HeadLWJ · Traditional | 10/21/1998SE |
| K983152 | Osteonics Spinal System 5.5MM & 10.0MM Bone ScrewsMNH · Special | 09/25/1998SE |
| K982553 | Osteo Compression Hip Screw SystemHRS · Traditional | 09/22/1998SE |
| K974685 | Osteonics Polyethylene Acetabular ComponentsJDI · Traditional | 09/22/1998SE |
| K982601 | Osteo Ic Retrograde/Antegrade Femoral NailHSB · Traditional | 09/14/1998SE |
| K982032 | Osteonics Omnifit Ha Hip Stem Series, Osteonics Secur-Fit Ha Hip Stem Series, Osteonics…MEH · Special | 07/09/1998SE |
| K981309 | Osteo I-C Humeral Nail SystemHSB · Traditional | 06/22/1998SE |
| K980766 | Osteonics Anteverted Neck Ha Hip StemsMEH · Traditional | 05/27/1998SE |
| K981452 | Osteonics Long Arm Containment RingKWP · Traditional | 05/20/1998SE |
| K981259 | Osteo 4.0MM Cannulated Screw SystemHWC · Traditional | 05/11/1998SE |
| K980594 | Osteonics Fx-Cablelok Grip ComponentsLYT · Traditional | 05/05/1998SE |
| K980502 | Osteonics Total Elbow SystemJDC · Traditional | 05/05/1998SE |
| K980774 | Osteonics Gap-Ii Restoration Acetabular ShellsLZO · Traditional | 04/29/1998SE |
| K974807 | Osteo Austin Moore Endoprosthesis SystemKWL · Traditional | 03/16/1998SE |
| K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemJWH · Traditional | 02/27/1998SE |
| K972967 | Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total…JWH · Traditional | 01/16/1998SN |
| K974434 | Osteonics Series 7000 Total Knee Anterior Femoral BlocksHRY · Traditional | 01/12/1998SN |
| K973438 | Osteo Bos System Product Line ExtensionHRS · Traditional | 12/09/1997SE |
| K973406 | Osteonics Series 7000 Total Knee Augmented Femoral ComponentJWH · Traditional | 12/08/1997SN |
| K973204 | Osteo Bos System in Stainless SteelHRS · Traditional | 09/25/1997SE |
| K972460 | Osteonics Omnifit-C Cemented Hip Stem (Line Extension)JDI · Traditional | 09/25/1997SE |
| K972323 | Osteo Bos SystemHRS · Traditional | 09/10/1997SE |
| K972196 | Osteo Anatomical Bone PlatesHRS · Traditional | 08/25/1997SE |
| K971962 | Osteo Kirschner WiresHTY · Traditional | 08/11/1997SE |
| K971800 | Osteo Cannulated Screw SystemHWC · Traditional | 07/30/1997SE |
| K971497 | Osteonics Anteverted Neck Hip StemLZO · Traditional | 07/16/1997SE |
| K971654 | Osteo Compression Hip Screw SystemHWC · Traditional | 07/09/1997SE |
| K971409 | Osteonics Alumina C-Taper HeadLZO · Traditional | 07/09/1997SE |
| K971321 | Osteo Compression Condyle Screw SystemHRS · Traditional | 07/09/1997SE |
| K971778 | Osteo Small and Mini Bone ScrewsHWC · Traditional | 06/27/1997SE |
| K970957 | Osteonics Restoration Acetabular RingJDJ · Traditional | 06/03/1997SE |
| K971422 | Osteonics Acetabular Wedge SystemMEH · Traditional | 05/22/1997SN |
| K970779 | Osteonics Tibial Tray Screw Hole PlugsLZN · Traditional | 05/09/1997SE |
| K970697 | Osteonics Normalized Ad Acetabular Component SystemJDI · Traditional | 04/24/1997SE |
| K970394 | Osteonics Normalized Ad-Ha Acetabular Component SystemMEH · Traditional | 04/22/1997SE |
| K965056 | Osteonics Screw Hole PlugsJDK · Traditional | 02/28/1997SE |
| K964893 | Hansson Pin SystemJDW · Traditional | 02/28/1997SE |
| K964544 | Osteonics Spinal System - Variable Offset Connector AssemblyMNH · Traditional | 02/11/1997SE |
| K963671 | Osteonics Flanged Polyethylene Acetabular CupJDI · Traditional | 02/03/1997SE |
| K963946 | Osteonics Modular Acetabular Cup (Microstructured Version)LPH · Traditional | 01/27/1997SE |
| K964304 | Osteonics Spinal System-Toploading Transverse Connector AssemblyMNH · Traditional | 01/17/1997SE |
| K963959 | Osteonics Modular Acetabular Cup (Ha-Coated Version)MEH · Traditional | 12/19/1996SE |
| K962314 | Halifax Plus Interlaminar Clamp SystemKWP · Traditional | 12/09/1996SE |
| K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee SystemJWH · Traditional | 08/14/1996SN |
| K962082 | Osteonics All Polyethylene Glenoid Shoulder ComponentKWS · Traditional | 08/13/1996SE |
| K962132 | Silkon Stainless Steel Cable SystemJDQ · Traditional | 08/08/1996SE |
| K955944 | Osteonics N2/VAC Packaging ProcessKWS · Traditional | 04/09/1996SE |
| K954598 | Osteonics Offset Hip StemsJDI · Traditional | 04/04/1996SE |
| K955731 | Osteonics Shoulder Humeral ComponentsKWS · Traditional | 03/05/1996SN |
| K955421 | Osteonics N2/VAC Packaging ProcessJWH · Traditional | 02/21/1996SE |
| K951517 | Osteonics Secur-Fit Ha Plus Hip Stem SeriesMEH · Traditional | 01/17/1996SN |
| K954534 | Osteonics Unipolar Endo HeadKWL · Traditional | 11/30/1995SE |
| K953961 | Osteonics Insight Knee Positioning & Alignment SystemFWW · Traditional | 11/29/1995SE |
| K954023 | Osteonics Secur-Fit Ha PSL Extra Acetabular Component SystemMEH · Traditional | 11/22/1995SE |
| K951725 | Osteonics Spinal SystemMNH · Traditional | 09/08/1995SE |
| K951671 | Osteonics Restoration Monolithic II Slotted Hip Stem SeriesMEH · Traditional | 09/06/1995SE |
| K951932 | Osteonics Restoration Monolithic II Hip Stem SeriesMEH · Traditional | 09/01/1995SE |
| K943778 | Osteonics Restoration Cemented Hip Stem SeriesKWL · Traditional | 08/14/1995SE |
| K933882 | Osteonics PS Hemi-Hip Stem SeriesLPH · Traditional | 08/14/1995SN |
| K951956 | Osteonics Series 7000 Total Knee Full Tibial Bone Augementation Blocks & WedgesJWH · Traditional | 08/11/1995SN |
| K951291 | Osteonics Restoration Monolithic Hip StemMEH · Traditional | 08/09/1995SN |
| K950521 | Osteonics All Polyethylene Glenoid Shoulder ComponentKWS · Traditional | 06/16/1995SE |
| K940715 | Osteonics Omnifit Ad Hip Stem SeriesLPH · Traditional | 06/07/1995SE |
| K941366 | Osteonics Omnifit Ad-Ha Hip Stem SeriesMEH · Traditional | 06/06/1995SE |
| K945574 | Osteonics(R) CCR Hip Stem SeriesJDI · Traditional | 05/30/1995SN |
| K946234 | Osteonics(R) Restoration Monolithic II Hip Stem SeriesMEH · Traditional | 04/10/1995SE |
| K944836 | Osteonics Restoration Monolithic II Hip Stem SeriesMEH · Traditional | 04/10/1995SN |
| K945691 | Osteonics(R) Threaded Ha Acetabular ShellsMEH · Traditional | 03/17/1995SN |
| K942900 | Osteonics Secure-Fit Ad-Ha Acetabular Component SystemMEH · Traditional | 03/15/1995SE |
| K943957 | Restoration Ha Acetabular Cup SeriesMEH · Traditional | 03/06/1995SN |
| K943774 | Osteonics Restoration Monolithic Hip StemLZO · Traditional | 03/06/1995SN |
| K940813 | Osteonics(R) Series 7000 Total KneeJWH · Traditional | 01/30/1995SN |
| K944285 | Osteonics Series 7000 Total Knee Femoral ComponentsJWH · Traditional | 12/19/1994SE |
| K943549 | Restoration Acetabular CupJDI · Traditional | 12/19/1994SE |
| K941128 | Osteonics Series 7000 Basic Femoral ComponentsJWH · Traditional | 12/08/1994SN |
| K943054 | Osteonics Secure-Fit Ad Acetabular Component SystemLPH · Traditional | 10/04/1994SE |
| K942809 | Acetabular Dome Hole PlugsJDL · Traditional | 09/20/1994SE |
| K935875 | Osteonics Screwless Acetabular ComponentsLPH · Traditional | 07/29/1994SN |
| K932519 | Osteonics(R) Omnifit(R) Normalized Hip StemLZO · Traditional | 03/10/1994SN |
| K933561 | Osteonics Omnifit Forged Hip Stem SeriesJDI · Traditional | 03/09/1994SN |
| K933359 | Osteonics 22MM, +10 Neck Bearing HeadsLWJ · Traditional | 03/07/1994SE |
| K930187 | Osteonics(R) Arc Depositioned Femoral ComponentsJDI · Traditional | 03/03/1994SE |
| K923011 | Osteonics Unix UnicompartmentalHRY · Traditional | 11/30/1993SE |
| K926201 | Osteonics Microsutered Femoral ComponentesLPH · Traditional | 06/22/1993SE |
| K925883 | Osteonics Microstructured Acetabular ComponentsJDJ · Traditional | 06/15/1993SE |
| K925695 | Omnifit Zirconia C-Taper Femoral Bearing HeadLZO · Traditional | 04/20/1993SE |
| K925372 | Osteonics(R) 700 Series Total Knee Mod Femor CompJWH · Traditional | 02/12/1993SE |
| K923616 | Omniflex-C Uhmwpe Mid-Shaft RestrictorJDK · Traditional | 10/30/1992SE |
| K915396 | Osteonics Zirconia C-Taper Femoral Bearing HeadLZO · Traditional | 10/20/1992SE |
| K922146 | Ostroncs Hemi-Hip Stem SeriesKWL · Traditional | 08/11/1992SE |
| K922104 | 7000 Series Total Knee Modular Component Cement CaJWH · Traditional | 08/11/1992SE |
| K920868 | Acetabular Dome and Screw Hole PlugsJDL · Traditional | 05/26/1992SE |
| K920524 | Osteonics 7000 Series Total Knee Bone AugmentationJWH · Traditional | 05/15/1992SE |
| K914565 | Osteonics 7000 Posterior Stab. Total Knee Fem. ComJWH · Traditional | 05/15/1992SE |
| K915192 | 7000 Series Modular Tibial ComponentsJWH · Traditional | 02/14/1992SE |
| K915186 | 7000 Series Total Knee Patellar ComponentsJWH · Traditional | 02/14/1992SE |
| K914406 | PT II Distal Cement SpacerJDI · Traditional | 12/20/1991SE |
| K913812 | Omnifit/Omniflex/Odc/Omnifit-Ha Hip Stem SeriesJDI · Traditional | 11/22/1991SE |
| K912654 | Omnifit Epf Dual Geometry Acetabular CupMEH · Traditional | 08/16/1991SE |
| K911728 | Omnifit(R) Epf Dual Geomtry/Radius/Thread Acetab CMEH · Traditional | 08/16/1991SE |
| K912147 | Osteonics 7000 Series Stand Total Knee Femor CompJWH · Traditional | 08/13/1991SE |
| K911890 | Osteonics(R) PRT Hip Stem SeriesJDI · Traditional | 07/26/1991SE |
| K911585 | Omnifit II Epf Hip Stem SeriesMEH · Traditional | 07/01/1991SE |
| K911373 | Osteonics Ion Implant Mod-Ml Uniknee Femoral CompHRY · Traditional | 06/26/1991SE |
| K910990 | Osteonics 7000 Series Total Knee Tibial ComponentsJWH · Traditional | 06/19/1991SN |
| K910989 | Osteonics Ion Implanted Total Knee Femoral CompJWH · Traditional | 06/05/1991SN |
| K910662 | PS Omnifit Normalized Hip Stem SeriesJDI · Traditional | 05/13/1991SE |
| K910461 | Osteonics(R) Mid-Shaft Cement SpacerJDK · Traditional | 04/08/1991SE |
| K910922 | Osteonics CDH Hip StemJDI · Traditional | 04/05/1991SE |
| K910083 | Omnifit Total Knee Bone Augmentation WedgesHSX · Traditional | 04/01/1991SE |
| K910988 | Osteonics Ion Implanted Femoral Bearing SeriesJDI · Traditional | 03/26/1991SE |
| K905275 | Osteonics(R) MPSS Hip Stem SeriesJDI · Traditional | 01/28/1991SN |
| K905406 | Osteonics Hip Revision WedgesJDI · Traditional | 01/04/1991SN |
| K905158 | Osteonics(R) 6011 Hip Stem SeriesJDI · Traditional | 01/04/1991SN |
| K896047 | The Omnifit Epf Hip Joint Femoral StemMEH · Traditional | 12/20/1990SN |
| K903636 | Osteonics DRM Acetabular ComponentJDI · Traditional | 10/30/1990SN |
| K902712 | Osteonics PS Head and Neck Hip Stem SeriesLZO · Traditional | 08/09/1990SN |
| K900438 | MC2P Acetabular ComponentJDI · Traditional | 04/18/1990SE |
| K900836 | Osteonics Ecsi Hip Stem SeriesJDI · Traditional | 03/21/1990SN |
| K900462 | Osteonics Cement RestrictorJDK · Traditional | 03/06/1990SE |
| K896856 | Mod-Ml Unicompartmental Knee ProsthesisHSX · Traditional | 02/06/1990SN |
| K895702 | KDR Acetabular ComponentLWJ · Traditional | 11/03/1989SE |
| K894694 | Omnifit Ceramic Morse Taper HeadLZO · Traditional | 10/12/1989SE |
| K894708 | PT Distal Tip Cement SpacerJDK · Traditional | 10/10/1989SE |
| K894124 | Omnifit Self Tapping Cancellous Bone ScrewsHWC · Traditional | 09/11/1989SN |
| K885102 | Omnifit Ceramic Morse Taper Head (1002 Series)LZO · Traditional | 06/22/1989SN |
| K891262 | KDG Acetabular ComponentLWJ · Traditional | 06/06/1989SE |
| K890197 | Omnifit Constrained Acetabular Bearing InsertKWZ · Traditional | 04/07/1989SE |
| K890649 | Omnifit Uhmwpe Acetabular Shell Cement Space Syst.JDI · Traditional | 03/13/1989SE |
| K884410 | Omnifit Total Knee Series Iii,Iv & Post. Stab. FemJWH · Traditional | 01/18/1989SN |
| K884398 | Omnifit Total Knee Series II Tibial InsertsJWH · Traditional | 01/17/1989SN |
| K883816 | Shoulder Microstructured Humeral ProsthesisKWS · Traditional | 11/10/1988SE |
| K883921 | Omnifit Threaded Acetabular Comp. W/Micro CoatingLWJ · Traditional | 10/13/1988SE |
| K881750 | Normal Humeral ProsthesisKWS · Traditional | 08/30/1988SE |
| K882812 | Omnifit Acetabular Shell Cement Spacer SystemJDI · Traditional | 08/08/1988SE |
| K874635 | Omnifit Total Knee Bone Augmentation WedgesJWH · Traditional | 03/10/1988SN |
| K872768 | Omniflex Normalized Hip Stem for Press-Fit Fixat.KWA · Traditional | 01/14/1988SE |
| K872528 | Omnifit Distal Stem Cement SpacersJDK · Traditional | 12/29/1987SE |
| K873251 | Omnifit Bone ScrewHWC · Traditional | 09/18/1987SN |
| K871769 | Omnifit(R) Total Knee System (Modification)JWH · Traditional | 06/02/1987SE |
| K870235 | Omnifit II Hip Prostheses: Cement FixationJDI · Traditional | 05/29/1987SN |
| K870216 | Microstructured Spherical Acetabular ComponentsJDI · Traditional | 03/20/1987SN |
| K862837 | Omnifit Total Knee Prosthesis SystemHSX · Traditional | 12/22/1986SN |
| K863668 | Omnifit (TM) Total Knee Prosthesis SystemJWH · Traditional | 12/19/1986SN |
| K864372 | Osteonics MC1 Metal-Back Acetabular Cup/Pmma Space · Traditional | 11/25/1986SE |
| K862535 | Osteonics Shoulder ProsthesisKWS · Traditional | 09/02/1986SE |
| K861680 | Osteonics Elbow ProsthesisJDC · Traditional | 06/27/1986SE |
| K861723 | (Modified) Omnifit Threaded Acetabular ComponentKWA · Traditional | 06/09/1986SE |
| K860654 | M.C.R. Knee Prosthesis (Series 3000)JWH · Traditional | 03/14/1986SN |
| K844818 | Normalized HS3N Proportional Series Hip StemsKWL · Traditional | 07/30/1985SE |
| K851404 | Omnifit Threaded Acetabular Components 2005 SeriesKWA · Traditional | 06/18/1985SE |
| K850352 | Micro-Struc. Acetabular Compon- MC2PJDL · Traditional | 04/25/1985SE |
| K844817 | Micro-Structured HS3P Proportional Series Hip StemJDI · Traditional | 03/12/1985SE |
| K833970 | Micro-Structured HS2P Hip StemsLWJ · Traditional | 01/27/1984SE |
| K833461 | HS4 Head/Neck Femoral Prostheses · Traditional | 12/27/1983SE |
| K831708 | Micro-Structured Surface Hip Prosthesis · Traditional | 09/15/1983SE |
| K823419 | HC 1M Metalbacked Acetabular CupJDI · Traditional | 01/17/1983SE |
| K812801 | Hip Stem System Titanium AlloyJDI · Traditional | 10/20/1981SE |
| K811500 | Colbalt Alloy Orthopaedic WireJDR · Traditional | 06/18/1981SE |
| K803192 | HCL Acetabular ComponentsKWZ · Traditional | 01/23/1981SE |
| K803191 | Prosthesis, Hip Femoral Component MetalKWL · Traditional | 01/23/1981SE |
| K800207 | Uhr UNIVERSAL6HIP ReplacementKWL · Traditional | 02/11/1980SE |