Prosthesis, Hip, Cement Restrictor
FDA product code JDK · Class II (moderate risk) · 21 CFR 878.3300 · General, Plastic Surgery
54510(k) clearances
0PMA approvals
12recalls
Implantimplanted device
Manufacturers
- Osteonics Corp. 6
- Spinal Concepts, Inc. 5
- Medtronic Sofamor Danek 5
- Medtronic Sofamor Danek USA, Inc. 2
- Spine Next SA 2
- Life Spine, Inc. 2
- Interpore Cross Intl. 2
- Theken Surgical,Llc 2
- Signus Medizintechnik GmbH 1
- Biodynamic Technologies, Inc. 1
- C.R. Bard, Inc. 1
- Turnkey Intergration USA, Inc. 1
- Sulzer Spine-Tech 1
- Signus Medical, LLC 1
- Joint Medical Products Corp. 1
- Medacta International S.A. 1
- New Business Development, LLC 1
- Centerpulse Spine-Tech, Inc. 1
- Osteonics Reconstructive Products Div. 1
- American Ortomed Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210062 | Mectaplug PE IIJDK · Traditional | Medacta International S.A. | 04/08/2021SE |
| K061465 | Kmi Cement Restrictor ImplantJDK · Traditional | Kinetikos Medical, Inc. | 10/05/2006SESU |
| K061698 | Modification to Life Spine Cement RestrictorJDK · Special | Life Spine | 07/12/2006SE |
| K060247 | Life Spine Cement RestrictorJDK · Traditional | Life Spine | 05/11/2006SESU |
| K060132 | Spinal USA Cement Restrictor SystemJDK · Traditional | Spinal USA | 03/16/2006SE |
| K051371 | Interbody Innovations Cement RestrictorJDK · Traditional | Interbody Innovations, Llp | 12/06/2005SESU |
| K051836 | Skelite Resorbable Cement RestrictorJDK · Traditional | Millenium Biologix, Inc. | 11/21/2005SESU |
| K051607 | Novaspine Cement Restrictor NSCRJDK · Traditional | Novaspine, LLC | 10/07/2005SE |
| K052367 | Scient'X Cement RestrictorJDK · Traditional | Scient'X | 10/05/2005SESU |
| K041382 | Polygraft BGS; Bone Graft SubstituteJDK · Traditional | Osteobiologics, Inc. | 06/17/2005SESU |
| K050699 | Modification to: Vented Cement Restrictor, Model 60102-000-001/004JDK · Special | Amedica Corp. | 04/15/2005SE |
| K041583 | PEEK Cement Restrictor X-BoxJDK · Traditional | Innovasis, Inc. | 07/22/2004SESU |
| K033953 | Optimesh 500E Cement RestrictorJDK · Traditional | Spineology, Inc. | 07/06/2004SESU |
| K040276 | Quantum Cement RestrictorJDK · Traditional | Quantum Orthopedics | 04/30/2004SE |
| K030871 | Fidji Large Cement RestrictorJDK · Traditional | Spine Next SA | 12/22/2003SESU |
| K030767 | Fidji Small Cement RestrictorJDK · Traditional | Spine Next SA | 12/22/2003SESU |
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZJDK · Special | Implex Corp. | 11/19/2003SE |
| K032180 | Nuvasive Cement RestrictorJDK · Traditional | Nuvasive, Inc. | 10/07/2003SESU |
| K031318 | Traxis Cement RestrictorJDK · Special | Spinal Concepts, Inc. | 08/22/2003SESU |
| K032095 | Interpore Cross Cement RestrictorJDK · Special | Interpore Cross Intl. | 08/08/2003SE |
| K031837 | Modification to Fortitude Cement RestrictorJDK · Special | Spinal Concepts, Inc. | 07/24/2003SE |
| K030608 | Oti Bone Cement PlugJDK · Traditional | Osteoimplant Technology, Inc. | 06/12/2003SESU |
| K023908 | Interpore Cross Cement RestrictorJDK · Traditional | Interpore Cross Intl. | 05/16/2003SESU |
| K023647 | Cadence PEEK Cemeent RestrictorJDK · Special | Spinal Concepts, Inc. | 11/27/2002SE |
| K022615 | Centerpulse, Spine-Tech Division Cement RestrictorJDK · Special | Centerpulse Spine-Tech, Inc. | 10/29/2002SESU |
| K021788 | NBD Cement Restrictor DeviceJDK · Traditional | New Business Development, LLC | 10/04/2002SESU |
| K021765 | Cement Restrictor, Small and LargeJDK · Traditional | Exactech, Inc. | 08/16/2002SE |
| K021719 | Fortitude Cement RestrictorJDK · Traditional | Spinal Concepts, Inc. | 08/15/2002SESU |
| K022218 | Cadence Cement RestrictorJDK · Traditional | Spinal Concepts, Inc. | 08/12/2002SE |
| K020836 | Rabea Cement RestrictorJDK · Traditional | Signus Medical, LLC | 06/11/2002SE |
| K020344 | RPX Titanium Cemnt RestrictorJDK · Traditional | Sulzer Spine-Tech | 05/02/2002SE |
| K013663 | Cement RestrictorJDK · Special | Medtronic Sofamor Danek, Inc. | 12/05/2001SESU |
| K012462 | Theken Large Cement RestrictorJDK · Traditional | Theken Surgical,Llc | 10/29/2001SESU |
| K012278 | Theken Small Cement RestrictorJDK · Traditional | Theken Surgical,Llc | 10/17/2001SESU |
| K010528 | Titanium Cement Restrictor Material PEEKJDK · Traditional | Medtronic Sofamor Danek USA, Inc. | 10/10/2001SESU |
| K013014 | Block Cement Restrictor (CR) - TitaniumJDK · Special | Medtronic Sofamor Danek, Inc. | 10/04/2001SESU |
| K011443 | Threaded Cement Restrictor (CR) TitaniumJDK · Traditional | Medtronic Sofamor Danek USA, Inc. | 08/03/2001SESU |
| K012255 | Medtronic Sofamor Danek Cement RestrictorJDK · Special | Medtronic Sofamor Danek, Inc. | 08/01/2001SESU |
| K011998 | Metronic Sofamor Danek Cement RestrictorJDK · Special | Medtronic Sofamor Danek, Inc. | 07/26/2001SESU |
| K003718 | Titanium Cement Restrictor (TCR)JDK · Traditional | Medtronic Sofamor Danek, Inc. | 02/14/2001SESU |
| K990345 | Rabea Device, Model PxxxxxxJDK · Traditional | Signus Medizintechnik GmbH | 07/30/1999SESU |
| K965056 | Osteonics Screw Hole PlugsJDK · Traditional | Osteonics Corp. | 02/28/1997SE |
| K926216 | Bone Cement RestrictorJDK · Traditional | Biodynamic Technologies, Inc. | 03/22/1994SE |
| K923616 | Omniflex-C Uhmwpe Mid-Shaft RestrictorJDK · Traditional | Osteonics Corp. | 10/30/1992SE |
| K911338 | Lima Cement RestrictorJDK · Traditional | Turnkey Intergration USA, Inc. | 06/28/1991SE |
| K910461 | Osteonics(R) Mid-Shaft Cement SpacerJDK · Traditional | Osteonics Corp. | 04/08/1991SE |
| K904746 | S-Rom(Tm) Femoral Stem Centralizer/Cement SpacerJDK · Traditional | Joint Medical Products Corp. | 11/20/1990SE |
| K900462 | Osteonics Cement RestrictorJDK · Traditional | Osteonics Corp. | 03/06/1990SE |
| K895378 | Proximal Cement SpacerJDK · Traditional | Osteonics Reconstructive Products Div. | 11/22/1989SE |
| K894708 | PT Distal Tip Cement SpacerJDK · Traditional | Osteonics Corp. | 10/10/1989SE |
| K872528 | Omnifit Distal Stem Cement SpacersJDK · Traditional | Osteonics Corp. | 12/29/1987SE |
| K840413 | Cement RestrictorJDK · Traditional | American Ortomed Corp. | 03/05/1984SE |
| K831512 | Dosimetry Release of Radiation SterilizJDK · Traditional | Biomet, Inc. | 09/29/1983SE |
| K831128 | Bard Intramedullary PlugJDK · Traditional | C.R. Bard, Inc. | 07/12/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1454-2024 Class II | MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-1690-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy…The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer… | Depuy Orthopaedics, Inc. | 01/27/2011Terminated |
| Z-1689-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy…The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer… | Depuy Orthopaedics, Inc. | 01/27/2011Terminated |
| Z-1688-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy…The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer… | Depuy Orthopaedics, Inc. | 01/27/2011Terminated |
| Z-1687-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy…The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer… | Depuy Orthopaedics, Inc. | 01/27/2011Terminated |
| Z-1686-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy…The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer… | Depuy Orthopaedics, Inc. | 01/27/2011Terminated |
| Z-0311-2008 | VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile…Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning:… | Encore Medical, Lp | 09/19/2007Terminated |
| Z-0310-2008 | VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile…Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning:… | Encore Medical, Lp | 09/19/2007Terminated |
| Z-0309-2008 | VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile…Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning:… | Encore Medical, Lp | 09/19/2007Terminated |
| Z-0308-2008 | VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile…Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning:… | Encore Medical, Lp | 09/19/2007Terminated |
| Z-0307-2008 | VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile…Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning:… | Encore Medical, Lp | 09/19/2007Terminated |
| Z-0306-2008 | VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile…Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning:… | Encore Medical, Lp | 09/19/2007Terminated |