# K131053: Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Dec 31, 2013 after 259 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002224 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965080: Anspach Micromax System, The Anspach Effort, Inc. (1997) Summary page 1.
- K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001) Summary page 1.
- K073255: XPS 3000 System, Medtronic Xomed, Inc. (2008) Summary page 1.

## Most influential descendants
- K180063: OCM-G1 Attachment (2018), 0 descendants of its own

## Recalls of this device
- Oct 6, 2016 · Class II · Z-2016-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Mar 28, 2016 · Class II · Z-1667-2016: Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
- Mar 28, 2016 · Class II · Z-1668-2016: Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.

## Indications for use
The ANSPACH XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium. When used with the ANSPACH Systems, the 0CM Attachment and 0CM Bunr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochicostomies.

Source page: https://510kreport.com/device/K131053
Methodology: https://510kreport.com/methodology