DePuy Spine, Inc.
Raynham, MA, US
DEPUY SPINE, INC. appears in FDA device records in Raynham, MA. FDA records list 71 510(k) clearances between and , 18 PMA records and one registered establishment. As of , FDA records show 57 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 71FDA records hold 71 510(k) clearances for DePuy Spine, Inc. between 2004 and 2022. The busiest year on record is 2008, with 15. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 9 |
| 2005 | 8 |
| 2006 | 7 |
| 2007 | 8 |
| 2008 | 15 |
| 2009 | 7 |
| 2010 | 9 |
| 2011 | 3 |
| 2012 | 2 |
| 2014 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | ODP | Substantially Equivalent | |
| K201831 | CONFIDENCE Spinal Cement System | NDN | Substantially Equivalent | |
| K142185 | EXPEDIUM VERSE SPINE SYSTEM | NKB | Substantially Equivalent | |
| K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM | NKB | Unknown | |
| K121020 | VIPER SYSTEM | NKB | Substantially Equivalent | |
| K110353 | MOUNTAINEER OCT SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM | NKB | Substantially Equivalent | |
| K103133 | VEPER SYSTEM, EXPEDIUM SYSTEM | NKB | Substantially Equivalent | |
| K101993 | VIPER SYSTEM, EXPEDIUM SYSTEM | NKB | Substantially Equivalent | |
| K101923 | CONCORDE CURVE SYSTEM | MAX | Substantially Equivalent | |
| K103100 | MOUNTAINEER OCT SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K101762 | VIPER F2 FACET FIXATION SYSTEM | MRW | Substantially Equivalent | |
| K102701 | VIPER SPINE SYSTEM | NKB | Substantially Equivalent | |
| K101933 | MODIFICATION TO:EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 | LYC | Substantially Equivalent | |
| K100070 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | NQW | Substantially Equivalent | |
| K092473 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K092626 | MODIFICATION TO: EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K090648 | VIPER 2 SYSTEM | NKB | Substantially Equivalent | |
| K081917 | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS | MAX | Substantially Equivalent | |
| K090899 | DEPUY SPINE LATERAL SYSTEM | MAX | Substantially Equivalent | |
| K090799 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K090230 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K082128 | DEPUY SPINE LATERAL CAGE SYSTEM | MAX | Substantially Equivalent | |
| K082942 | MODFICATION TO: EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K082273 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K081898 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K082195 | MODIFICATIONS TO EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K081758 | HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 | MQV | Substantially Equivalent | |
| K081432 | HEALOS II BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | |
| K080828 | MOUNTAINEER OCT SPINAL SYSTEM | MNH | Substantially Equivalent | |
| K081252 | EXPEDIUM 4.5MM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K073562 | MODIFICATION TO VIPER SPINE SYSTEM | NKB | Substantially Equivalent | |
| K080313 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K080568 | X-MESH EXPANDABLE CAGE SYSTEM | MQP | Substantially Equivalent | |
| K073364 | EXPEDIUM 4.5MM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K080191 | EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K073649 | BENGAL STACKABLE CAGE SYSTEM | MQP | Substantially Equivalent | |
| K073126 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K072546 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K070387 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K071860 | MODIFICATION TO: VIPER SPINE SYSTEM | NKB | Substantially Equivalent | |
| K063772 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K070994 | EAGLE + ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K070300 | EXPEDIUM SFX CROSS CONNECTOR SYSTEM | KWP | Substantially Equivalent | |
| K063741 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K062814 | PIPELINE II ACCESS SYSTEM | GZT | Substantially Equivalent | |
| K063156 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | |
| K062174 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | MNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1526439 | 1526439 | DEPUY SPINE, INC. | 325 Paramount Drive, RAYNHAM, MA 02767 US | 2026 | and 98 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- HRXArthroscope
- HWJAwl
- HTWBit, Drill
- HTQBroach
- GEACannula, Surgical, General & Plastic Surgery
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- FZOChisel, Surgical, Manual
- HXDClamp
- HTFCurette
- GDIDissector, Surgical, General & Plastic Surgery
- HWRDriver, Prosthesis
- GFCDriver, Surgical, Pin
- HTEElevator
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HAOInstrument, Surgical, Non-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HTSKnife, Orthopedic
- FQHLavage, Jet
- FSTLight, Surgical, Fiberoptic
- FSQLight, Surgical, Instrument
- EZXMesh, Surgical, Metal
- GEYMotor, Surgical Instrument, Ac-Powered
- GAANeedle, Aspiration And Injection, Disposable
- GABNeedle, Suturing, Disposable
- HAWNeurological Stereotaxic Instrument
- FWZOperating Room Accessories Table Tray
- HWMOsteotome
- GFIOsteotome, Manual
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- HWPPunch, Femoral Neck
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- GCZRetainer, Surgical
- GADRetractor
- GZTRetractor, Self-Retaining, For Neurosurgery
- HTXRongeur
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- FMFSyringe, Piston
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- HAXTong, Skull For Traction
- FSMTray, Surgical, Instrument
- HWKTrephine
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 57| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1324-2022 | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton | Class II | Open, Classified | |
| Z-1323-2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton | Class II | Open, Classified | |
| Z-1226-2019 | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L) | A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | Class II | Terminated | |
| Z-1225-2019 | Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C) | A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | Class II | Terminated | |
| Z-1300-2018 | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma). | Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray. | Class II | Terminated | |
| Z-0630-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0629-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0628-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0627-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0626-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0625-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0624-2017 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | Terminated | |
| Z-0454-2016 | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. | Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length | Class II | Terminated | |
| Z-1674-2015 | EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 | Device does not mate as intended. | Class II | Terminated | |
| Z-0097-2014 | PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. | Class II | Terminated | |
| Z-0096-2014 | PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. | Class II | Terminated | |
| Z-0095-2014 | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. | Class II | Terminated | |
| Z-0094-2014 | PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. | Class II | Terminated | |
| Z-0093-2014 | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. | Class II | Terminated | |
| Z-2134-2013 | CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. | Class II | Terminated | |
| Z-2133-2013 | CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. | Class II | Terminated | |
| Z-2132-2013 | CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. | Class II | Terminated | |
| Z-0963-2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | Class II | Terminated | |
| Z-0962-2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | Class II | Terminated | |
| Z-0961-2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain