Data / Medical devices / United States / Depuy Spine, Inc.
Depuy Spine, Inc.: FDA-registered device maker in Raynham, MA, United States, 258 510(k) clearances and 1 PMA approval
Depuy Spine, Inc. is registered with the FDA (registration 1526439) in Raynham, MA, United States. It lists 108 device types. The FDA files 258 510(k) clearances and 1 PMA approval under its listings, the newest dated May 26, 2026. 15 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1526439
- Address
- 325 Paramount Drive, Raynham, MA, United States, 02767
- Owner or operator
- DePuy Spine, Inc. (1526439)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- May 17, 1987
- Registered through
- 2027
- Brand names listed
- ACROMED, ADS Bone Nail, AEGIS, ALC Dynamized, Ace Halo, Ace Halo, Ace Halo Measuring Tape, Ace Halo Vest System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 258.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2026 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | OLO | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| March 27, 2026 | K260240 | SYMPHONY Navigation Ready Instruments | OLO | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 22, 2025 | K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| October 21, 2025 | K253249 | TriALTIS Spine System | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 24, 2025 | K251648 | GPS Advanced; GPS Advanced Cannula | FMF | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| January 17, 2025 | K243249 | TriALTIS Spine System | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 16, 2024 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | OLO | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 9, 2024 | K242042 | TriALTIS Spine System | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 10, 2024 | K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | FMF | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| June 17, 2024 | K233256 | Robotic Integration Instruments | OLO | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| June 17, 2024 | K233255 | CROSSNAV Navigation Enabled Instruments | OLO | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| June 14, 2024 | K233254 | TELIGEN System Navigation Ready Instruments | OLO | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| June 14, 2024 | K233228 | Spine Navigation and Robotic-Assistance Device | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| December 12, 2023 | K233684 | TriALTIS Spine System | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| November 9, 2023 | K233366 | SYMPHONY OCT System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 29, 2023 | K231527 | TriALTIS Navigation Enabled Instruments | OLO | Substantially Equivalent | Medos International Sàrl | accessdata.fda.gov |
| September 22, 2023 | K231479 | TriALTIS Spine System | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| March 8, 2023 | K223688 | CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments | MAX | Substantially Equivalent | Medos International Sàrl | accessdata.fda.gov |
| February 10, 2023 | K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | PDQ | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| January 19, 2023 | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | OLO | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 18, 2022 | K213978 | TELIGEN System | HRX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 15, 2022 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | ODP | Substantially Equivalent | Depuy Spine | accessdata.fda.gov |
| October 13, 2022 | K222473 | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods | NKB | Substantially Equivalent | Medos-International Sarl | accessdata.fda.gov |
| August 25, 2022 | K221325 | CONDUIT Lateral Switch Plate | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| August 23, 2022 | K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| March 8, 2022 | K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| May 6, 2021 | K210728 | CONDUIT Instruments | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| February 5, 2021 | K203319 | SYMPHONY OCT System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 15, 2020 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| April 2, 2020 | K192646 | SYMPHONY OCT System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 24, 2019 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System | PGM | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 18, 2019 | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| February 4, 2019 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| December 20, 2018 | K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| October 12, 2018 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| October 4, 2018 | K181949 | SYMPHONY OCT System | NKG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| April 6, 2018 | K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| December 15, 2017 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| October 25, 2017 | K173095 | VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 11, 2017 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| June 30, 2017 | K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| May 24, 2017 | K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| May 4, 2017 | K170543 | VIPER PRIME Screws with Fenestrations | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| December 20, 2016 | K160879 | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems | PML | Substantially Equivalent | Medos International Sàrl | accessdata.fda.gov |
| December 8, 2016 | K162912 | VIPER PRIME additions to the VIPER® System | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 1, 2016 | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| November 20, 2015 | K151773 | CONCORDE Bullet Lumbar Interbody System | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 8, 2015 | K151352 | CONCORDE Bullet Spinal System | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 3, 2015 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | NKG | Substantially Equivalent | Depuy Synthes, Inc. | accessdata.fda.gov |
| March 25, 2015 | K143533 | FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| November 19, 2014 | K142185 | EXPEDIUM VERSE SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| October 24, 2014 | K140927 | UNIVERSAL NAVIGATION INSTRUMENTS | OLO | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 1, 2014 | K142460 | EXPEDIUM Spine System/Synapse System | KWP | Substantially Equivalent | Johnson and Johnson | accessdata.fda.gov |
| August 22, 2014 | K141509 | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | PGM | Substantially Equivalent | Medos Sarl | accessdata.fda.gov |
| June 13, 2014 | K140759 | BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 12, 2013 | K131802 | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM | OSH | Substantially Equivalent | Depuy Spine, A Johnson & Johnson Company | accessdata.fda.gov |
| September 6, 2013 | K132324 | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST | KWQ | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| August 22, 2013 | K132332 | MOUNTAINEER OCT SPINAL SYSTEM | KWP | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 20, 2013 | K130877 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 18, 2012 | K122896 | COUGAR LS 15 LATERAL CAGE SYSTEM | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 20, 2012 | K120867 | VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS | OLO | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 3, 2012 | K120966 | DEPUY PULSE LUMBAR CAGE SYSTEM | MAX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 14, 2012 | K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM | NKB | Unknown | Depuy Spine, Inc. | accessdata.fda.gov |
| May 3, 2012 | K121020 | VIPER SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| January 27, 2012 | K113273 | SPOTLIGHT ACCESS SYSTEM | GZT | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| December 16, 2011 | K112913 | SPOTLIGHT ACCESS SYSTEM | GZT | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| October 26, 2011 | K110551 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| October 11, 2011 | K110694 | CONCORDE BULLET SPINAL SYSTEM | MAX | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| July 6, 2011 | K111571 | VIPER SYSTEMS | NKB | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| May 13, 2011 | K110454 | COUGAR LS LATERAL CAGE SYSTEM | MAX | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| April 1, 2011 | K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| February 17, 2011 | K103490 | EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM | NKB | Substantially Equivalent | Johnson & Johnson | accessdata.fda.gov |
| February 14, 2011 | K103491 | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | A Johnson & Johnson Company | accessdata.fda.gov |
| January 18, 2011 | K103133 | VEPER SYSTEM, EXPEDIUM SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| November 15, 2010 | K101762 | VIPER F2 FACET FIXATION SYSTEM | MRW | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| October 20, 2010 | K102701 | VIPER SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| October 18, 2010 | K101933 | MODIFICATION TO:EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| August 31, 2010 | K101070 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| May 25, 2010 | K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 | LYC | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| February 4, 2010 | K100070 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| January 7, 2010 | K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | NQW | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| November 25, 2009 | K092473 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| September 25, 2009 | K092626 | MODIFICATION TO: EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| June 10, 2009 | K090648 | VIPER 2 SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| May 22, 2009 | K081917 | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS | MAX | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| March 6, 2009 | K090230 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| November 14, 2008 | K082128 | DEPUY SPINE LATERAL CAGE SYSTEM | MAX | Substantially Equivalent | Depuy Spine | accessdata.fda.gov |
| October 31, 2008 | K082942 | MODFICATION TO: EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| September 10, 2008 | K082273 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| September 3, 2008 | K081758 | HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 | MQV | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| August 29, 2008 | K081432 | HEALOS II BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| May 30, 2008 | K081252 | EXPEDIUM 4.5MM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| May 8, 2008 | K080313 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| May 1, 2008 | K080568 | X-MESH EXPANDABLE CAGE SYSTEM | MQP | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| April 4, 2008 | K073364 | EXPEDIUM 4.5MM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| April 2, 2008 | K080191 | EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| January 25, 2008 | K073649 | BENGAL STACKABLE CAGE SYSTEM | MQP | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| November 21, 2007 | K071927 | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | NDN | Substantially Equivalent | Depuy Spine, A Johnson & Johnson Company | accessdata.fda.gov |
| October 5, 2007 | K072546 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| September 18, 2007 | K070387 | EXPEDIUM SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 2, 1999 | P960025 | BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS | MAX | 11 | March 17, 2004 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2022 | 90390 | Class II | Ongoing | 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 | accessdata.fda.gov |
| April 8, 2019 | 82587 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 15, 2017 | 79494 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| October 12, 2016 | 75454 | Class II | Terminated | 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 dis | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | accessdata.fda.gov |
| November 20, 2015 | 72654 | Class II | Terminated | 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 | accessdata.fda.gov |
| April 21, 2015 | 71067 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 31, 2013 | 65897 | Class II | Terminated | 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. | accessdata.fda.gov |
| April 17, 2013 | 64937 | Class II | Terminated | 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 fr | 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. | accessdata.fda.gov |
| January 15, 2013 | 64072 | Class II | Terminated | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. 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 | accessdata.fda.gov |
| November 7, 2012 | 63665 | Class II | Terminated | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component. | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | accessdata.fda.gov |
| July 24, 2012 | 62719 | Class II | Terminated | DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. | A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification. | accessdata.fda.gov |
| March 22, 2011 | 58271 | Not yet classified | Terminated | Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety | Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle | accessdata.fda.gov |
| October 2, 2010 | 56894 | Not yet classified | Terminated | Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy | The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy | accessdata.fda.gov |
| February 11, 2009 | 51138 | Not yet classified | Terminated | DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to f | Tip of Driver may break during use | accessdata.fda.gov |
| October 10, 2006 | 36504 | Not yet classified | Terminated | DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100 | Sterility of device is compromised due to loss of package integrity | accessdata.fda.gov |
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Updated May 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.