# K113476: Anspach Dissection Tools - Pathway: 510(k) (Special) - Applicant: The Anspach Effort, Inc. - Decided: Dec 16, 2011 after 24 days - Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)) - Device class: 2 - Regulation: 21 CFR 882.4310 - Recalls of this device: 39 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K011444 (2001). 3 ancestors in all. 13 later devices descend from it; 6 cite it directly. 0 of 17 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K080802: Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal, The Anspach Effort, Inc. (2008) Summary page 1. - K042783: Anspach Minimal Access Spinal Attachment (Masa) System, The Anspach Effort, Inc. (2004) Summary page 1. ## Most influential descendants - K130755: Hicut Highspeed Instrument (2014), 4 descendants of its own - K232684: Surgify Halo (2023), 3 descendants of its own - K173066: OSSEODUO Shaver and Drill System (2018), 3 descendants of its own - K250380: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (2025), 2 descendants of its own - K251433: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (2025), 1 descendant of its own ## Recalls of this device - Aug 26, 2016 · Class II · Z-2840-2016: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. - Aug 26, 2016 · Class II · Z-2837-2016: Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed. - Aug 26, 2016 · Class II · Z-2839-2016: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. - Aug 26, 2016 · Class II · Z-2838-2016: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. - Apr 13, 2015 · Class II · Z-2283-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2307-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2285-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2308-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2294-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2309-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2310-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2282-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2288-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2313-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2284-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2302-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2297-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2292-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2301-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2280-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2306-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2290-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2293-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2299-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2289-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2295-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2304-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2281-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2296-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2305-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2312-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2311-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2298-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2286-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2303-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2287-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2300-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Apr 13, 2015 · Class II · Z-2291-2015: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachm - Mar 4, 2011 · Class II · Z-1377-2013: Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. ## Indications for use Dissection tools are intended for cutting and shaping bone including spine and cranium. Source page: https://510kreport.com/device/K113476 Methodology: https://510kreport.com/methodology