# K080802: Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal - Pathway: 510(k) (Special) - Applicant: The Anspach Effort, Inc. - Decided: Apr 30, 2008 after 40 days - Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)) - Device class: 2 - Regulation: 21 CFR 882.4310 - Recalls of this device: 35 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K011444 (2001). 1 ancestor in all. 14 later devices descend from it; 2 cite it directly. 0 of 16 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001) Summary page 2. ## Most influential descendants - K113476: Anspach Dissection Tools (2011), 13 descendants of its own - 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 ## Recalls of this device - Oct 6, 2016 · Class II · Z-1949-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2031-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1948-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2001-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1956-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1952-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2026-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2019-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2015-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2032-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1955-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1957-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Dec 17, 2013 · Class II · Z-0726-2014: Some carbide cutting burr fractured during use. - Dec 17, 2013 · Class II · Z-0727-2014: Some carbide cutting burr fractured during use. - Dec 17, 2013 · Class II · Z-0728-2014: Some carbide cutting burr fractured during use. - Dec 17, 2013 · Class II · Z-0729-2014: Some carbide cutting burr fractured during use. - Nov 28, 2012 · Class II · Z-1892-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1880-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1893-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1891-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1879-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1889-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1885-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1878-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1886-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1888-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1877-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1887-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1890-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Nov 28, 2012 · Class II · Z-1881-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. - Jan 9, 2012 · Class II · Z-0074-2013: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. - Jan 9, 2012 · Class II · Z-0076-2013: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. - Jan 9, 2012 · Class II · Z-0075-2013: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. - May 6, 2011 · Class II · Z-0200-2014: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent rev - Aug 13, 2009 · Not classified · Z-0083-2010: The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield con ## Indications for use The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium. Source page: https://510kreport.com/device/K080802 Methodology: https://510kreport.com/methodology