Cement Obturator
FDA product code LZN · Class II (moderate risk) · 21 CFR 878.3300 · General, Plastic Surgery
37510(k) clearances
0PMA approvals
8recalls
Implantimplanted device
Manufacturers
- Howmedica Corp. 5
- Isotis NV 2
- Allo Pro Corp. 2
- American Design Group, Inc. 2
- Sunmed, Inc. 2
- Johnson & Johnson Professionals, Inc. 2
- Biomedical Devices, Inc. 1
- Howmedica Osteonics, Dba Stryker Orthopaedics 1
- Osteonics Corp. 1
- Orthopaedic Innovations, Inc. 1
- Depuy, Inc. 1
- Landos, Inc. 1
- Implex Corp. 1
- Johnson & Johnson Orthopaedics, Inc. 1
- Biodynamic Technologies, Inc. 1
- Sofamor Danek Mfg., Inc. 1
- Orthomet, Inc. 1
- Biotron , Ltd. 1
- Dow Corning Corp. Healthcare Industries Materials 1
- Cintor Orthopaedic Div. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement RestrictorLZN · Traditional | Howmedica Osteonics, Dba Stryker Orthopaedics | 05/20/2022SE |
| K061824 | Tornier Cement RestrictorLZN · Traditional | Tornier | 09/14/2006SE |
| K032685 | Cemstop Cement RestrictorLZN · Traditional | Teknimed, S.A. | 11/26/2003SE |
| K023680 | Biobuck Cement RestrictorLZN · Special | Smith & Nephew, Inc. | 11/19/2002SE |
| K011943 | Impro Vise Absorbable Cement Flow RestrictorLZN · Traditional | Kensey Nash Corp. | 09/19/2001SE |
| K010840 | SynplugLZN · Special | Isotis NV | 04/20/2001SE |
| K993841 | Cemstop Cement RestrictorLZN · Traditional | Encore Orthopedics, Inc. | 05/04/2000SE |
| K000587 | Shuttle StopLZN · Traditional | Isotis NV | 05/04/2000SE |
| K992462 | Osteonics Universal Distal Cement PlugLZN · Traditional | Howmedica Osteonics Corp. | 08/13/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | Turnkey Intergration USA, Inc. | 08/29/1997SE |
| K970779 | Osteonics Tibial Tray Screw Hole PlugsLZN · Traditional | Osteonics Corp. | 05/09/1997SE |
| K955632 | Orthoplug Soft Bone DesignLZN · Traditional | Sunmed, Inc. | 02/27/1996SE |
| K955631 | Orthoplug Hard Bone DesignLZN · Traditional | Sunmed, Inc. | 02/27/1996SE |
| K955751 | Prime Femoral Cement PlugLZN · Traditional | Orthopaedic Innovations, Inc. | 01/26/1996SE |
| K951930 | Cementralizer Distal Stem CentralizerLZN · Traditional | Depuy, Inc. | 07/11/1995SE |
| K951934 | PFC Cement RestrictorLZN · Traditional | Johnson & Johnson Professionals, Inc. | 05/16/1995SN |
| K951860 | Howmedice Bone PlugLZN · Traditional | Howmedica Corp. | 05/16/1995SN |
| K933077 | Exeter Intramedullary Bone PlugLZN · Traditional | Howmedica Corp. | 05/16/1995SN |
| K943727 | Biostop G Bone Cement RestrictorLZN · Traditional | Landos, Inc. | 05/11/1995SE |
| K943378 | Implex Cement Restrictor SystemLZN · Traditional | Implex Corp. | 09/23/1994SE |
| K942060 | P.F.C. Cement RestrictorLZN · Traditional | Johnson & Johnson Professionals, Inc. | 09/20/1994SE |
| K932595 | Orthosorb(Tm) Absorbable Cement RestrictorLZN · Traditional | Johnson & Johnson Orthopaedics, Inc. | 09/20/1994SE |
| K931847 | Bio-Prep Cement RestrictorLZN · Traditional | Biomedical Devices, Inc. | 06/28/1994SE |
| K931540 | Universal Bone Cement KitLZN · Traditional | Biodynamic Technologies, Inc. | 01/27/1994SE |
| K920118 | ResorabplugLZN · Traditional | Sofamor Danek Mfg., Inc. | 02/08/1993SE |
| K923909 | Cement Restrictor for Proforma and Perfecta TotalLZN · Traditional | Orthomet, Inc. | 11/04/1992SE |
| K911717 | Adg Intramedullary Bone Plug - VentedLZN · Traditional | American Design Group, Inc. | 09/04/1991SE |
| K910135 | The Universal Cement Plug(Tm)LZN · Traditional | Biotron , Ltd. | 03/05/1991SE |
| K902615 | Adg Bone PlugLZN · Traditional | American Design Group, Inc. | 09/11/1990SE |
| K900392 | Centering PlugLZN · Traditional | Allo Pro Corp. | 03/01/1990SE |
| K890326 | Hip Fracture Stem System - Fenestration PlugLZN · Traditional | Howmedica Corp. | 02/03/1989SE |
| K853186 | Silastic Inflatable Bone Plug H.P.LZN · Traditional | Dow Corning Corp. Healthcare Industries Materials | 09/24/1985SE |
| K852449 | Howmedica Hip Sys Distal Centralizing SpacerLZN · Traditional | Howmedica Corp. | 08/12/1985SE |
| K830949 | Polyethylene Medullary Plug - Stiihmer/LZN · Traditional | Allo Pro Corp. | 04/12/1983SE |
| K810353 | Harris Cement RestrictorLZN · Traditional | Cintor Orthopaedic Div. | 02/23/1981SE |
| K791125 | Plug-Lok Cement RestirctorLZN · Traditional | Richard'S Medical Equip., Inc. | 06/27/1979SE |
| K771408 | Wrought (Forged) VitalliumLZN · Traditional | Howmedica Corp. | 08/04/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2602-2023 Class II | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-2601-2023 Class II | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-2600-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox.…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-2599-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-2598-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-2597-2023 Class II | Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-2596-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | Stryker Corporation | 08/07/2023Open, Classified |
| Z-0951-2023 Class II | BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000…All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because… | Depuy Ireland UC | 12/19/2022Open, Classified |