Dispenser, Cement
FDA product code KIH · Class I (low risk) · 21 CFR 888.4200 · Orthopedic
11510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042591 | Smartmix Pre-Filled Mixing SystemKIH · Special | DePuy Orthopaedics, Inc. | 10/22/2004SE |
| K943906 | P.F.C. Cement Pressurizing SystemKIH · Traditional | Johnson & Johnson Professionals, Inc. | 12/21/1994SE |
| K897134 | CMW Cement Pressurisation SystemKIH · Traditional | Dentsply Intl. | 03/02/1990SE |
| K851881 | Orthopeadic Cement Delivery SystemKIH · Traditional | Dentsply Intl. | 06/13/1985SE |
| K840046 | Pressurizing/Scavenging Acrylic CementKIH · Traditional | Precision Medical Devices, Inc. | 02/09/1984SE |
| K833675 | Brigham Tibial Cement PressurizerKIH · Traditional | Howmedica Corp. | 12/12/1983SE |
| K811317 | Howmedica Femoral Pressuring SealKIH · Traditional | Howmedica Corp. | 05/29/1981SE |
| K801388 | Oh-HarrisKIH · Traditional | Johnson & Johnson Professionals, Inc. | 07/28/1980SE |
| K790275 | Gun, Exeter CementKIH · Traditional | Howmedica Corp. | 02/21/1979SE |
| K781955 | Gun, CementKIH · Traditional | Depuy, Inc. | 12/04/1978SE |
| K780266 | Bone Cement ApplicatorKIH · Traditional | Zimmer, Inc. | 02/28/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1081-2019 Class II | Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation…Lack of an adequate sterilization validation | Zimmer Biomet, Inc. | 02/28/2019Terminated |
| Z-2772-2015 Class II | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures…Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging… | Orthovita, Inc., dBA Stryker Orthobiologics. | 08/20/2015Terminated |
| Z-1744-2015 Class II | The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet…The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of… | Biomet France S.A.R.L. | 05/14/2015Terminated |
| Z-1198-2012 | Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the…The firm identified two complaints have been reported indicating that the product inside the package did not… | Stryker Instruments Div. of Stryker… | 01/13/2012Terminated |
| Z-3188-2011 | Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of…Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its… | Orthovita, Inc. | 03/31/2011Terminated |