Drills, Burrs, Trephines & Accessories (Simple, Powered)
FDA product code HBE · Class II (moderate risk) · 21 CFR 882.4310 · Neurology
65510(k) clearances
0PMA approvals
258recalls
Manufacturers
- Stryker Corporation 7
- The Anspach Effort, Inc. 7
- Aesculap, Inc. 5
- Surgify Medical OY 4
- Medtronic Powered Surgical Solutions 2
- Nuell Air Equipment & Hospital Supplies, Inc. 2
- Nakanishi, Inc. 2
- Medtronic Xomed, Inc. 2
- Medtronic Sofamor Danek USA, Inc. 2
- Stryker Instruments 2
- Acra Cut, Inc. 2
- Biomet Microfixation, Inc. 2
- Hubly, Inc. 2
- Adeor Medical AG 2
- Mednext, Inc. 1
- Komet Medical 1
- Phasor Health, LLC 1
- Micro Surgical Instruments Corp. 1
- A. Henniss 1
- Micro-Aire Surgical Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional | Surgify Medical OY | 03/26/2026SE |
| K250815 | Hubly Drill (H100)HBE · Traditional | Hubly, Inc. | 11/06/2025SE |
| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
| K252662 | UniBurHBE · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 06/04/2025SE |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 03/13/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | Stryker Instruments | 03/11/2025SE |
| K232684 | Surgify HaloHBE · Traditional | Surgify Medical OY | 11/29/2023SE |
| K230619 | Hubly Electric Drill (H100)HBE · Traditional | Hubly, Inc. | 05/04/2023SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | Biomet Microfixation | 11/15/2022SE |
| K213072 | 2.1 x 255mm Drill, 22mm StopHBE · Traditional | Biomet Micofixation | 08/23/2022SE |
| K213208 | Twist DrillsHBE · Traditional | Biomet Microfixation | 12/23/2021SE |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…HBE · Special | Medtronic Powered Surgical Solutions | 11/23/2021SE |
| K202120 | P300 AttachmentHBE · Traditional | Nakanishi, Inc. | 10/22/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | Aesculap, Inc. | 08/24/2021SE |
| K210377 | Stryker iBur hubs and cutting accessoriesHBE · Traditional | Stryker Corporation | 06/30/2021SE |
| K191479 | Velocity Alpha Highspeed Surgical Drill SystemHBE · Traditional | Adeor Medical AG | 04/11/2021SE |
| K183203 | ELAN 4 ToolsHBE · Traditional | Aesculap, Inc. | 08/09/2019SE |
| K183545 | Anspach Helix Dissection ToolsHBE · Traditional | The Anspach Effort, Inc. | 07/19/2019SE |
| K191049 | Stryker MIS and Footed AttachmentsHBE · Traditional | Stryker Corporation | 06/18/2019SE |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE · Traditional | Stryker | 06/14/2019SE |
| K182527 | ELAN 4 ToolsHBE · Traditional | Aesculap, Inc. | 01/19/2019SE |
| K172709 | ELAN 4 Electro Motor System ToolsHBE · Traditional | Aesculap, Inc. | 10/17/2018SE |
| K182436 | POWEREASE SystemHBE · Special | Medtronic Sofamor Danek USA, Inc. | 10/04/2018SE |
| K170442 | Cranial Drill Bits and AccessoriesHBE · Traditional | Ad-Tech Medical Instrument Corporation | 09/07/2017SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | Osteomed | 05/19/2017SE |
| K161704 | Phasor DrillHBE · Traditional | Biotex, Inc. | 12/01/2016SE |
| K153519 | DRealHBE · Traditional | Carevature Medical, Ltd. | 03/16/2016SE |
| K143399 | Stryker Footed Attachments and Cutting AccessoriesHBE · Traditional | Stryker Corp. | 05/08/2015SE |
| K143540 | Stryker MIS Attachments and Cutting AccessoriesHBE · Traditional | Stryker Corporation | 05/01/2015SE |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE · Traditional | Stryker Corp. | 04/23/2015SE |
| K130755 | Hicut Highspeed InstrumentHBE · Traditional | Adeor Medical AG | 06/27/2014SE |
| K132436 | Varioguide Drill KitHBE · Traditional | Mri Interventions, Inc. | 03/20/2014SE |
| K123270 | Powerease SystemHBE · Traditional | Medtronic Sofamor Danek USA, Inc. | 01/11/2013SE |
| K121264 | Triton Electric High Torque Handpiece and Software ModuleHBE · Traditional | Medtronic Surgical Technologies | 08/27/2012SE |
| K113476 | Anspach Dissection ToolsHBE · Special | The Anspach Effort, Inc. | 12/16/2011SE |
| K111520 | Ipc Powerease SystemHBE · Traditional | Medtronic Xomed, Inc. | 10/26/2011SE |
| K081475 | Electric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power…HBE · Traditional | Medtronic Xomed, Inc. | 10/17/2008SE |
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…HBE · Special | The Anspach Effort, Inc. | 04/30/2008SE |
| K072315 | Midas Rex Curved BurHBE · Special | Medtronic Powered Surgical Solutions | 09/18/2007SE |
| K070876 | Stryker Twist DrillsHBE · Traditional | Stryker Craniomaxillofacial | 04/27/2007SE |
| K062842 | Twist DrillHBE · Traditional | Walter Lorenz Surgical, Inc. | 12/04/2006SE |
| K050628 | Anspach CouplerHBE · Traditional | The Anspach Effort, Inc. | 04/07/2005SE |
| K042783 | Anspach Minimal Access Spinal Attachment (Masa) SystemHBE · Traditional | The Anspach Effort, Inc. | 12/17/2004SE |
| K040076 | Anspach Advanced Micro Saw AttachmentsHBE · Traditional | The Anspach Effort, Inc. | 03/15/2004SE |
| K032303 | Stryker Consolidated Operating Room Equipment (Core) SystemHBE · Traditional | Stryker Instruments | 01/16/2004SE |
| K030172 | Small High Speed Motor Drill SystemHBE · Traditional | Brasseler USA I, L.P. | 04/03/2003SE |
| K022942 | CraniocutHBE · Traditional | Aesculap, Inc. | 10/21/2002SE |
| K014060 | Microaire 1000E SystemHBE · Traditional | Microaire Surgical Instruments, Inc. | 03/05/2002SE |
| K002903 | Anspach Angled Micronose AttachmentHBE · Traditional | The Anspach Effort, Inc. | 10/24/2000SE |
| K984035 | XK-95 High Speed Motor Drill SystemHBE · Traditional | Komet Medical | 06/03/1999SE |
| K943541 | 75K Staight DrillHBE · Traditional | Stryker Corp. | 05/18/1995SE |
| K935861 | Mednext BurHBE · Traditional | Mednext, Inc. | 05/03/1994SE |
| K930229 | Clinical Neuro Systems Cranial DrillHBE · Traditional | Clinical Neuro Systems, LLC | 03/16/1993SE |
| K922299 | Zeppelin Motor Drill SystemHBE · Traditional | Von Zeppelin Chirurgische Instrumente GmbH | 10/13/1992SE |
| K911819 | Acra-Cut Neurological Surgical Device-PoweredHBE · Traditional | Acra Cut, Inc. | 09/10/1991SE |
| K911812 | Acra-Cut Wire Pass DrillHBE · Traditional | Acra Cut, Inc. | 09/10/1991SE |
| K905097 | Micro-Aire Model Number: MK-426HBE · Traditional | Micro Surgical Instruments Corp. | 12/21/1990SE |
| K902703 | Craniotome Blade or Drill BitHBE · Traditional | A. Henniss | 11/13/1990SE |
| K903664 | Micro-Aire Wire Pass and Craniotome DrillHBE · Traditional | Micro-Aire Surgical Instruments, Inc. | 09/13/1990SE |
| K900388 | Modified Sterilization of Drills, Burrs, TrephinesHBE · Traditional | Midas Rex Pneumatic Tools, Inc. | 05/07/1990SE |
| K881418 | Craniotome Blade or Neuro BladeHBE · Traditional | Nuell Air Equipment & Hospital Supplies, Inc. | 05/31/1988SE |
| K880601 | Wire Pass Drill BitsHBE · Traditional | Nuell Air Equipment & Hospital Supplies, Inc. | 05/06/1988SE |
| K875224 | Hudson Craninal BurrsHBE · Traditional | Tri-Med, Inc. | 01/28/1988SE |
| K873692 | Raylor(Tm) Drill StopHBE · Traditional | Cedar Surgical, Inc. | 12/17/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2573-2026 Class II | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2572-2026 Class II | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2571-2026 Class II | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2570-2026 Class II | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2569-2026 Class II | Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2568-2026 Class II | Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines &…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2567-2026 Class II | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2566-2026 Class II | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2565-2026 Class II | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2564-2026 Class II | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2563-2026 Class II | Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2562-2026 Class II | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2561-2026 Class II | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2560-2026 Class II | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2559-2026 Class II | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2558-2026 Class II | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2557-2026 Class II | Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2556-2026 Class II | Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2555-2026 Class II | Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs…Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Surgify Medical OY | 04/30/2026Open, Classified |
| Z-2461-2025 Class II | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC…Due to out of the box wobble of the driver. | Medtronic Xomed, Inc. | 07/17/2025Open, Classified |
| Z-2192-2025 Class II | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase… | Phasor Health, LLC | 03/21/2025Open, Classified |
| Z-0063-2025 Class II | 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming…May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin… | Stryker Corporation | 09/05/2024Open, Classified |
| Z-2731-2024 Class II | Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2730-2024 Class II | Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2729-2024 Class II | Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2728-2024 Class II | Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2727-2024 Class II | Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2726-2024 Class II | Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2725-2024 Class II | Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2724-2024 Class II | Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2723-2024 Class II | Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-2722-2024 Class II | Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | Stryker Corporation | 07/24/2024Completed |
| Z-0982-2025 Class II | stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone…There is potential the device inside the package may not match the product information on the outer label… | Stryker Corporation | 06/28/2023Open, Classified |
| Z-0981-2025 Class II | stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement…There is potential the device inside the package may not match the product information on the outer label… | Stryker Corporation | 06/28/2023Open, Classified |
| Z-0980-2025 Class II | The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut…There is potential the device inside the package may not match the product information on the outer label… | Stryker Corporation | 06/28/2023Open, Classified |
| Z-1478-2022 Class II | Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy…There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break… | Stryker Instruments | 06/24/2022Open, Classified |
| Z-0158-2022 Class II | Medtronic Sterile single-use blades that are components of the StraightShot M Series…There was an increase in complaints related to tip breaks and wobble/vibration. | Medtronic Xomed, Inc. | 08/31/2021Open, Classified |
| Z-2539-2018 Class II | AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing…The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting… | Ad-Tech Medical Instrument Corporation | 05/02/2018Terminated |
| Z-0621-2018 Class II | ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4…ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Aesculap Implant Systems LLC | 09/05/2017Terminated |
| Z-0620-2018 Class II | ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4…ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Aesculap Implant Systems LLC | 09/05/2017Terminated |
| Z-0619-2018 Class II | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING…ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Aesculap Implant Systems LLC | 09/05/2017Terminated |
| Z-0874-2017 Class II | 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-0873-2017 Class II | 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-0872-2017 Class II | 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-0871-2017 Class II | 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-0870-2017 Class II | 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-0869-2017 Class II | 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-0868-2017 Class II | 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS…Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs… | Stryker Instruments Div. of Stryker… | 11/30/2016Terminated |
| Z-1998-2017 Class II | IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1997-2017 Class II | IMRI SHORT ATTACHMENT Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |