# K011444: Anspach Emax Drill System - Pathway: 510(k) (Traditional) - Applicant: The Anspach Effort, Inc. - Decided: Aug 8, 2001 after 89 days - Product code: HBC (Motor, Drill, Electric) - Device class: 2 - Regulation: 21 CFR 882.4360 - Recalls of this device: 70 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 36 later devices descend from it; 9 cite it directly. 0 of 37 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA has not posted a summary or statement for it, so its predicates are not known. ## Most influential descendants - K080802: Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal (2008), 14 descendants of its own - K113476: Anspach Dissection Tools (2011), 13 descendants of its own - K020688: Hydrocision Arthojet System with Cautery and Turboburr (2002), 8 descendants of its own - K032529: Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310 (2003), 6 descendants of its own - K041233: Arthrojet XT (2004), 5 descendants of its own ## Recalls of this device - Dec 7, 2022 · Class II · Z-0924-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0917-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0921-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0919-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0922-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0923-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0916-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0920-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Dec 7, 2022 · Class II · Z-0918-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend - Oct 6, 2016 · Class II · Z-2023-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1931-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1946-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1933-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1953-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1930-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1950-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1988-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2012-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2025-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2022-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2020-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1994-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1985-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1932-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2014-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1999-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2024-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1951-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1987-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1958-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1991-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2029-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1947-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2027-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1954-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2013-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2000-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2028-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1990-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-1986-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2030-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2002-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Jan 8, 2014 · Class II · Z-1574-2014: Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. - May 6, 2013 · Class II · Z-0779-2014: Product did not reach expected sterility assurance level - Nov 28, 2012 · Class II · Z-1904-2014: 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-1912-2014: 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-1895-2014: 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-1908-2014: 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-1909-2014: 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-1913-2014: 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. Source page: https://510kreport.com/device/K011444 Methodology: https://510kreport.com/methodology