# K061297: Anspach Imri Safe Surgical Drill System

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Jan 26, 2007 after 262 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 MRI Surgical Drill System: named in the summary without a submission number
- (no number) MicroMax: named in the summary without a submission number
- (no number) the original 65K: named in the summary without a submission number

## Recalls of this device
- Apr 25, 2013 · Class II · Z-0657-2014: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (
- Sep 19, 2011 · Class II · Z-2077-2012: Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is
- May 18, 2007 · Not classified · Z-1008-2007: The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

## Indications for use
The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

Source page: https://510kreport.com/device/K061297
Methodology: https://510kreport.com/methodology