# K042783: Anspach Minimal Access Spinal Attachment (Masa) System - Pathway: 510(k) (Traditional) - Applicant: The Anspach Effort, Inc. - Decided: Dec 17, 2004 after 72 days - Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)) - Device class: 2 - Regulation: 21 CFR 882.4310 - Recalls of this device: 31 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 14 later devices descend from it; 1 cites it directly. 0 of 15 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) Anspach Angled Micro-nose Attachment: named in the summary without a submission number - (no number) Medtronic (Midas Rex) "Micro-Telescoping System": named in the summary without a submission number ## 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-2003-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2009-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2004-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2007-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2011-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2005-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 6, 2016 · Class II · Z-2006-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval. - Oct 26, 2012 · Class II · Z-0708-2014: During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the inte - Mar 29, 2012 · Class II · Z-0715-2014: Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs. - Mar 29, 2012 · Class II · Z-0753-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0762-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0763-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0764-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0758-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0759-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0761-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0768-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0750-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0754-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0749-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0751-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0752-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0755-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0756-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0757-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0760-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0765-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0766-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0767-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Mar 29, 2012 · Class II · Z-0769-2014: The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be - Oct 13, 2010 · Not classified · Z-2903-2011: On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a ## Indications for use The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium. Source page: https://510kreport.com/device/K042783 Methodology: https://510kreport.com/methodology