Depuy Spine, Inc.
Medical device manufacturer in Raynham, MA.
71510(k) clearances
2PMA approvals
57recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 30
- KWQ Appliance, Fixation, Spinal Intervertebral… 10
- KWP Appliance, Fixation, Spinal Interlaminal 5
- MQP Spinal Vertebral Body Replacement Device 4
- MAX Intervertebral Fusion Device With Bone… 4
- MNI Orthosis, Spinal Pedicle Fixation 3
- MQV Filler, Bone Void, Calcium Compound 3
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- NDN Cement, Bone, Vertebroplasty 2
- LYC Bone Grafting Material, Synthetic 2
- OUR Sacroiliac Joint Fixation 1
- GZT Retractor, Self-Retaining, For Neurosurgery 1
- NQW Orthosis, Spine, Plate, Laminoplasty, Metal 1
- MRW System, Facet Screw Spinal Device 1
- ODP Intervertebral Fusion Device With Bone… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG PuttyODP · Traditional | 10/15/2022SE |
| K201831 | CONFIDENCE Spinal Cement SystemNDN · Traditional | 08/31/2020SE |
| K142185 | Expedium Verse Spine SystemNKB · Traditional | 11/19/2014SE |
| K111136 | Expedium Spine System, Viper System, Viper 2 SystemNKB · Traditional | 06/14/2012SESU |
| K121020 | Viper SystemNKB · Special | 05/03/2012SE |
| K110353 | Mountaineer Oct Spinal SystemKWP · Special | 04/07/2011SE |
| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
| K101923 | Concorde Curve SystemMAX · Special | 12/01/2010SE |
| K103100 | Mountaineer Oct Spinal SystemMNI · Special | 11/17/2010SE |
| K101762 | Viper F2 Facet Fixation SystemMRW · Special | 11/15/2010SE |
| K102701 | Viper Spine SystemNKB · Special | 10/20/2010SE |
| K101933 | Modification To:Expedium Spine SystemNKB · Special | 10/18/2010SE |
| K093390 | Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025LYC · Special | 05/25/2010SE |
| K100070 | Uniplate Anterior Cervical Plate SystemKWQ · Special | 02/04/2010SE |
| K091994 | Mountaineer Laminoplasty SystemNQW · Traditional | 01/07/2010SE |
| K092473 | Expedium Spine SystemNKB · Special | 11/25/2009SE |
| K092626 | Modification to: Expedium Spine SystemNKB · Special | 09/25/2009SE |
| K090648 | Viper 2 SystemNKB · Special | 06/10/2009SE |
| K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsMAX · Traditional | 05/22/2009SE |
| K090899 | Depuy Spine Lateral SystemMAX · Traditional | 05/19/2009SE |
| K090799 | Modification to Expedium Spine SystemNKB · Special | 04/22/2009SE |
| K090230 | Expedium Spine SystemNKB · Special | 03/06/2009SE |
| K082128 | Depuy Spine Lateral Cage SystemMAX · Traditional | 11/14/2008SE |
| K082942 | Modfication to: Expedium Spine SystemNKB · Special | 10/31/2008SE |
| K082273 | Uniplate Anterior Cervical Plate SystemKWQ · Special | 09/10/2008SE |
| K081898 | Expedium Spine SystemNKB · Special | 09/10/2008SE |
| K082195 | Modifications to Expedium Spine SystemNKB · Special | 09/03/2008SE |
| K081758 | Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…MQV · Traditional | 09/03/2008SE |
| K081432 | Healos II Bone Graft SubstituteLYC · Traditional | 08/29/2008SE |
| K080828 | Mountaineer Oct Spinal SystemMNH · Special | 06/27/2008SE |
| K081252 | Expedium 4.5MM Spine SystemNKB · Special | 05/30/2008SE |
| K073562 | Modification to Viper Spine SystemNKB · Traditional | 05/15/2008SE |
| K080313 | Modification to Expedium Spine SystemNKB · Special | 05/08/2008SE |
| K080568 | X-Mesh Expandable Cage SystemMQP · Special | 05/01/2008SE |
| K073364 | Expedium 4.5MM Spine SystemNKB · Special | 04/04/2008SE |
| K080191 | Eagle Plus Micro Anterior Cervical Plate SystemKWQ · Special | 04/02/2008SE |
| K073649 | Bengal Stackable Cage SystemMQP · Special | 01/25/2008SE |
| K073126 | Expedium Spine SystemNKB · Special | 12/06/2007SE |
| K072546 | Swift Plus Anterior Cervical Plate SystemKWQ · Special | 10/05/2007SE |
| K070387 | Expedium Spine SystemNKB · Traditional | 09/18/2007SE |
| K071860 | Modification to: Viper Spine SystemNKB · Special | 08/01/2007SE |
| K063772 | Expedium Spine SystemNKB · Traditional | 07/10/2007SE |
| K070994 | Eagle + Anterior Cervical Plate SystemKWQ · Special | 05/09/2007SE |
| K070300 | Expedium SFX Cross Connector SystemKWP · Special | 04/10/2007SE |
| K063741 | Expedium Spine SystemNKB · Special | 01/17/2007SE |
| K062814 | Pipeline II Access SystemGZT · Traditional | 12/15/2006SE |
| K063156 | Modification to Expedium Spine SystemNKB · Special | 11/22/2006SE |
| K062174 | Modification to Expedium Spine SystemMNH · Special | 11/02/2006SE |
| K062495 | Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemMQV · Traditional | 10/13/2006SE |
| K062196 | SFX Snap-Fit Cross ConnectorMNH · Traditional | 09/11/2006SE |
| K061520 | Viper Spine SystemNKB · Special | 06/23/2006SE |
| K052546 | Aegis Anterior Lumbar Plate SystemKWQ · Traditional | 02/03/2006SE |
| K052746 | Concorde VBR Spinal SystemMQP · Special | 10/21/2005SE |
| K052552 | Hybrid Anterior Cervical Plate SystemKWQ · Special | 10/13/2005SE |
| K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsKWP · Special | 09/28/2005SE |
| K051296 | Sijf Cannulated Screw SystemOUR · Traditional | 08/26/2005SE |
| K043406 | Vertebroplastic Radiopaque Bone CementNDN · Traditional | 07/15/2005SE |
| K051024 | Expedium Spine SystemNKB · Special | 07/06/2005SE |
| K050675 | Expedium Spine System Spinous Process Fusion PlateMNI · Traditional | 04/11/2005SE |
| K043308 | Modification to: Healos Bone Graft MaterialMQV · Special | 02/16/2005SE |
| K042544 | Uniplate Anterior Cervical Plate SystemKWQ · Traditional | 11/23/2004SE |
| K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemKWP · Special | 10/07/2004SE |
| K041722 | Modification to VBR Spinal SystemMQP · Special | 09/23/2004SE |
| K041801 | Expedium Mis Spine SystemNKB · Traditional | 09/08/2004SE |
| K041205 | Expedium Anterior Spine SystemKWQ · Traditional | 08/17/2004SE |
| K041119 | Expedium Spine SystemKWP · Special | 07/19/2004SE |
| K041203 | Summit Oct Spinal SystemMNI · Special | 06/02/2004SE |
| K040655 | Swift Anterior Cervical Plate SystemKWQ · Special | 06/02/2004SE |
| K033901 | Merlin Spine SystemNKB · Traditional | 03/31/2004SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1324-2022 Class II | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use…Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and… | 05/20/2022Open, Classified |
| Z-1323-2022 Class II | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use…Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and… | 05/20/2022Open, Classified |
| Z-1226-2019 Class II | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23…A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | 04/08/2019Terminated |
| Z-1225-2019 Class II | Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21…A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | 04/08/2019Terminated |
| Z-1300-2018 Class II | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN:…Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is… | 12/15/2017Terminated |
| Z-0630-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0629-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0628-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0627-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0626-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0625-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0624-2017 Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x…SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 10/12/2016Terminated |
| Z-0454-2016 Class II | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the…Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble… | 11/20/2015Terminated |
| Z-1674-2015 Class II | EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm…Device does not mate as intended. | 04/21/2015Terminated |
| Z-0097-2014 Class II | PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0096-2014 Class II | PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0095-2014 Class II | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0094-2014 Class II | PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0093-2014 Class II | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-2134-2013 Class II | CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal…During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body… | 04/17/2013Terminated |
| Z-2133-2013 Class II | CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE…During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body… | 04/17/2013Terminated |
| Z-2132-2013 Class II | CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal…During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body… | 04/17/2013Terminated |
| Z-0963-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |
| Z-0962-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |
| Z-0961-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |
| Z-0960-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |
| Z-0713-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long… | 11/07/2012Terminated |
| Z-0712-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0711-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0710-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0709-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0708-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0707-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0706-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0705-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0685-2013 Class II | DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is…A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially… | 07/24/2012Terminated |
| Z-2103-2011 | Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The…Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle | 03/22/2011Terminated |
| Z-2102-2011 | Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The…Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle | 03/22/2011Terminated |
| Z-0819-2011 | Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code:…The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw… | 10/02/2010Terminated |
| Z-0818-2011 | Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code:…The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw… | 10/02/2010Terminated |
| Z-0817-2011 | Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The…The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw… | 10/02/2010Terminated |
| Z-1670-2009 | DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF:…Tip of Driver may break during use | 02/11/2009Terminated |
| Z-0144-2007 | HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0143-2007 | Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0142-2007 | Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0141-2007 | Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0140-2007 | Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0139-2007 | Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0138-2007 | Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0137-2007 | Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0136-2007 | Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HISterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0135-2007 | Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HISterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0134-2007 | Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0133-2007 | Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0132-2007 | 12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0131-2007 | 0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0130-2007 | DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |